Tuesday, November 13, 2018

Gram-Positive Bacterial Infections Market to Observe Strong Development by 2020

Source:  Taxis Pharmaceuticals, Inc. 9/24/18

Bacteria represents essential class of micro-organisms that play a crucial role in the development of infection of any disease to the human being and animal kingdom. Bacteria are divided into two types on the basis of gram staining test, namely; gram-positive bacteria and gram-negative bacteria.

Gram-positive bacteria retain the gram stain and hence are observed as violet purple colored stains when observed under microscope. These are distinguished from gram-negative bacteria, which are colored with red stains. Gram-positive bacteria represents the major class of bacteria and are responsible for infecting humans and animals with variety of acute and chronic diseases. Gram-positive bacteria are further divided on the basis of their shapes, such as, cocci and bacilli.

The Gram-Positive Bacterial Infections Market is segmented on the basis of various bacteria that belongs to the class, such as, bacillus, lactobacillus, actinomyces, clostridium, staphylococcus, streptococcus, listeria, enterococcus, mycobacterium, and many others. Further, the market is also segmented on the basis of diseases caused by gram-positive bacteria, such as, tuberculosis and other respiratory diseases, anthrax, newborn meningitis, acne, and many others. Moreover, it is segmented on the basis of antibacterial drugs, such as, B-lactum antibiotics (Penicillin), clavulanic acid (Augmentin), aminoglycosides (Streptomycin), glycopeptides (Vancomycin), polypeptides (Bacitracin), rifamycins (Rifampicin), chloramphenicol, tetracycline and many others.

Additionally, the market is segmented on the basis of geography, such as, North America, Europe, Asia-Pacific and Rest of the World (RoW). At present, North America and Europe are the most prominent markets, owing to growing prevalence of various gram-positive bacterial infections and associated diseases. However, Asia-Pacific and some countries in RoW region are expected to show lucrative growth in upcoming period, owing to rapidly growing prevalence and awareness about the diseases caused due to gram-positive bacteria and their chronic effects.

The market is expected to show a prominent growth during the forecast period 2014 – 2020. This growth is expected to be driven by factors, such as, increasing prevalence of various gram positive bacterial infections and extensive R&D practices ongoing across the globe. These factors are supported by rising awareness about infections and diseases and increasing medical expenditure. Rising prevalence of infectious diseases is the most important factor that drive the growth of the market to a higher end. According to the WHO, tuberculosis is the second greatest killer across the globe and killed around 1.3 million people in 2012, throughout the world. Thus, such infections prevalence is an important growth driver of the market.

Further, due to extensive R&D practices, a number of drugs and formulations are on the way to enter in the market during the forecast period 2014 -2020. Some of the important pipeline products include LTX-109, PYN-6, RX-P792, XF-70, and TD-1607 amongst others. In addition, various schemes by the WHO, such as, DOTS and Stop TB Strategy (particular for tuberculosis), helps in increasing awareness amongst the population, that fuels the growth of the market. On the other hand, factors such as government austerity, high cost of treatment and R&D, and ignorance towards the symptoms may hamper the growth of the market to certain extent.

Some of the major players engaged in R&D and commercialization of the products in the Gram-Positive Bacterial Infections market include Basilea Pharmaceuticals Ltd., Cubist Pharmaceuticals, Novabiotics Ltd., TAXIS Pharmaceuticals, Inc., Aphios Corporation, Pfizer, Inc., GSK plc, Theravance, Inc. amongst many others.

Monday, November 12, 2018

Hemispherx Outlines Ampligen Combination Therapy Clinical Study Strategy for the Treatment of Multiple Cancers in Letter to Stockholders


Source:  Hemispherx Biopharama, Inc. 10/22/18

Hemispherx Biopharma, Inc. (NYSE American: HEB) announces that Thomas K. Equels, President and Chief Executive Officer, has issued a Letter to Stockholders providing a business update. The full text of the Letter, which has also been posted to the Company's website, is as follows.

To Our Stockholders,
The primary focus of today’s Letter is to update you on the great strides we have made in our oncology programs with Ampligen. In recent months Hemispherx has made significant advancements with our Ampligen oncology program and Ampligen’s potential use as an immuno-oncology agent for the treatment of multiple types of cancer. This has been a priority for our Company, and me personally, since I became CEO in 2016. We have remained focused on fulfilling our promises to advance these important clinical goals. I am pleased to announce that we are supporting six separate clinical studies in eight solid tumors at major research institutions.

In parallel, we continue to pursue Ampligen for the treatment of severe myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). Ampligen is approved for this indication in Argentina (the first and only meaningful therapy approved anywhere in the world for ME/CFS) and is available through an U.S. Food and Drug Administration (FDA) authorized expanded access program (EAP), AMP-511, a program where the FDA has approved the reimbursement rate of $200 per vial for the direct costs and where we are expanding participation at clinics in Nevada and North Carolina.

Ampligen and Oncology
In collaboration with major cancer research centers in the U.S. and around the world, we have been making tremendous progress and strongly believe in the future of our cancer-fighting efforts. We believe the true value of Ampligen is not yet well-understood by the pharma industry, many clinicians or investors. Therefore, I believe it is important that you, our stockholders, understand not only what we are doing in this field, but also why we are doing it. It is also important that you have the opportunity to see what these top experts in immuno-oncology have to say about their recent successes with Ampligen and its importance as a promising agent for advances in oncology. Progress in oncology provides a clear opportunity for commercial success for Hemispherx.

We are working closely with and have initiated the steps to proceed with important clinical studies at the University of Pittsburgh Medical Center (UPMC), the University of Nebraska Medical Center (UNMC) and Roswell Park Comprehensive Cancer Center (Roswell Park). We expect that the Institutions will conduct and complete these clinical trials on an expedited basis. The goal of these various studies will be to conclusively test the hypothesis that the combination of Ampligen with checkpoint blockade therapies will improve clinical tumor responses, time to progression and survival in humans. Checkpoint inhibitors have provided dramatic responses for a number of advanced end stage cancers by enabling the patient’s immune system to attack the cancer. Although a minority of patients respond dramatically to the checkpoint inhibitors, we believe that use of combinational immune therapy to enhance immune killing of tumor cells provides a rational mechanism for expanding the clinical response rate for checkpoint inhibitor therapy.

In early October, Hemispherx signed a Clinical Trial Agreement with Roswell Park in Buffalo, N.Y. to conduct clinical studies of Ampligen in combination with checkpoint inhibitors in three solid tumors, namely urothelial carcinoma (bladder and associated structures), renal cell carcinoma and melanoma. Additional clinical studies of Ampligen plus checkpoint blockade therapies in five other solid tumors — triple-negative breast, colorectal, ovarian, non-small cell lung and pancreatic carcinomas — are at various stages of development, from early protocol drafts to having secured FDA authorization to proceed with human subjects. These five other clinical trials will be conducted at Roswell Park, UPMC or UNMC beginning in the near future.

In summary, Hemispherx is currently collaborating on the start of clinical trials with three U.S.-based world-class cancer research centers to study Ampligen in combination with checkpoint inhibitors that are already approved by the FDA. Checkpoint inhibitors are powerful immuno-therapy drugs that block proteins that restrain the body’s immune system from fighting cancer, and they are used in a number of advanced solid tumor malignancies. The object of these combination clinical trials is to measure improvements in therapeutic outcomes. The need stems from the fact that checkpoint blockade therapies work poorly with so-called “cold” tumors. Clinical proof-of-concept findings using an Ampligen cocktail in colorectal carcinoma demonstrated a more favorable ratio of killer T-cells to regulatory T-cells in the tumor microenvironment. Killer T-cells attack cancer cells, and their presence in the tumor microenvironment can be inhibited by regulatory (suppressor) T-cells in the tumor microenvironment. The suppressor cells thereby reduce a patient’s immune response to cancer. Increases in killer T-cells, without a corresponding increase in suppressor T-cells, therefore, is an indicator of the body’s increased ability to mount a potentially effective immune response, supporting strong pre-clinical evidence of Ampligen’s activity in converting “cold” tumors into “hot” tumors.

In a head-to-head study in explant culture models, Ampligen activated the TLR3 pathway and promoted an accumulation of killer T-cells, but unlike two other TLR3 agonists, it did so without causing regulatory T-cell (Treg) attraction. These findings, published in the journal Cancer Research (http://cancerres.aacrjournals.org/content/early/2018/05/31/0008-5472.CAN-17-3985), are important because they show that Ampligen selectively reprograms the tumor microenvironment by inducing the beneficial aspects of tumor inflammation (attracting killer T-cells), without amplifying immune-suppressive elements such as regulatory, ‘suppressor’, T-cells. The anti-tumor activity of Ampligen has been recognized by oncology investigators in a multiplicity of peer reviewed scientific publications. The ability to reprogram the tumor microenvironment favoring enhanced anti-cancer activity of the checkpoint inhibitors has provided the rationale for initiating clinical proof of concept studies in a variety of advanced (lethal) cancers.

"Ampligen has the potential to be clinically significant because a robust killer T-cell population in the tumor microenvironment without attracting Treg cells is important to help optimize checkpoint blockade induced tumor shrinkage," said Robert P. Edwards, MD, chair of gynecologic services at Magee-Women’s Hospital of the University of Pittsburgh School of Medicine (UPMC), Professor of Obstetrics, Gynecology & Reproductive Services at UPMC, a world-class expert in ovarian cancer and a pioneer in Ampligen research.

His views are vigorously reiterated by another world renowned expert and Ampligen pioneer, Pawel Kalinski, MD, PhD, Rustum Family Professor for Molecular Therapeutics and Translational Research, Vice Chair for Translational Research and Director of Cancer Vaccine and Dendritic Cell Therapies at Roswell Park Comprehensive Cancer Center, who states, “There is significant and pressing need for new therapy options that can extend the benefits of checkpoint inhibition to the patients who currently do not respond to these treatments. We’re excited about initiating our planned basket trial incorporating Ampligen to see whether these combination approaches can successfully convert ‘cold’ tumors into ‘hot’ ones that will respond to these therapies. Our preclinical findings indicate that this is a worthwhile strategy to pursue.”

One of the solid tumors that we are targeting at UNMC in our combination therapy clinical studies with Ampligen is pancreatic cancer, which is a prime example of the unmet medical needs we are striving to meet. We also have an ongoing Dutch-approved standalone Ampligen EAP in pancreatic cancer at Erasmus M.C. that is more than a year old. Statistically, only 6-7% of patients diagnosed with pancreatic cancer are alive five years after diagnosis, and more than 100,000 people will die this year in the U.S. and Europe from this dreaded malignancy. Today, a diagnosis of pancreatic cancer is a virtual death sentence. Hemispherx, working with Erasmus and UNMC, intends to change that. We have every hope that the upcoming clinical trial at UNMC will pave the way for progress in pancreatic cancer. We at Hemispherx strongly believe that this work is important, will make a difference and ultimately will save lives. As one of the world’s top pancreatic cancer researchers, Michael A. (Tony) Hollingsworth, PhD, head of pancreatic cancer research at UNMC’s Buffett Cancer Center states, “We are working hard to discover better treatments for pancreatic cancer. We believe Ampligen is an agent that holds tremendous promise — not only for pancreatic cancer, but also for a variety of other cancers.”

I hope that if, as stockholders, you understand this program, you may better appreciate why we are moving so aggressively on this clinical path. I believe success in oncology will lead to lasting commercial success for our company. Over the past two years we have aggressively and successfully pursued meaningful relationships with top cancer research centers in the U.S. We then, at these same institutions, aggressively and successfully pursued pre-clinical animal studies to show our hypothesis has great merit. Initial proof of concept clinical work was similarly successful. Now we are commencing at these same top institutions, led by top experts in their fields, clinical studies in a variety of solid tumors which we have every expectation will establish Ampligen as an important agent in immuno-oncology.

Fighting Cancer and Beyond
We have two pipeline drugs that show tremendous progress in fighting debilitating conditions for countless people with unmet medical needs, Ampligen, and our FDA approved product, Alferon® N Injection. We have our own manufacturing site and a proven ability to produce our pipeline products. We have an active EAP in the Netherlands in pancreatic cancer, and are in midst of expanding our EAP for ME/CFS in the U.S. We have the first ever commercial approval in severe ME/CFS from Argentina. What’s more, over the past two years, we have successfully collaborated with Erasmus M.C., the Hillman Cancer Center at UPMC, the Fred & Pamela Buffett Cancer Center at UNMC and Roswell Park. These are all highly respected research centers in the field of cancer treatment. We strongly believe that successes in our six independent immuno-oncology clinical studies targeting eight types of solid tumors will create significant long-term value for our stockholders.
In addition to the above detailed clinical work:

We can manufacture our product
  • Two commercial sized lots totaling over 16,000 vials have been filled, finished and released for use. We announced in August that the new Ampligen batch manufactured earlier this year was released for patient use in the pancreatic cancer EAP in the Netherlands. This was the initial shipment (500 vials) of a previously announced 2,100 vial standing stock order issued by myTomorrows, our EAP provider in Europe.
We are making a difference in the U.S. and Globally
  • We are working to expand the U.S.-based EAP, known as AMP-511, an FDA-authorized open-label program for severe ME/CFS.
  • We announced in September that our regulatory inspection and clearance for distribution of our second commercial scale lot of Ampligen, slated for multiple uses including product launch in Argentina for the treatment of ME/CFS, our ME/CFS EAP in the U.S. and Europe and the pancreatic cancer EAP in the Netherlands.
Hemispherx is a small company, but holds great promise. Our pledge to stockholders is that we will continue to pursue all available opportunities to advance our pipeline, with the goals of offering therapeutics that will truly make a difference in the lives of patients and, at the same time, build stockholder value.
We will continue to keep you apprised of our progress in these efforts as we go forward. Thank you for your continued support of Hemispherx Biopharma.

Sincerely,
Thomas K. Equels
President and Chief Executive Officer
October 22, 2018

Hemispherx Biopharma Signs Clinical Trial Agreement with Roswell Park Comprehensive Cancer Center to Study Ampligen in Combination with Checkpoint Inhibitors in a Phase IIa Study in Urothelial Carcinoma, Renal Cell Carcinoma and Melanoma

Source:  Hemispherx Biopharma, Inc. 10/10/18

New Agreement Expands Existing Preclinical Collaborations

Hemispherx Biopharma, Inc. (NYSE American: HEB) announces the signing of a clinical trial agreement with Roswell Park Comprehensive Cancer Center to evaluate Ampligen in combination with checkpoint inhibitors (CPIs). The Phase IIa clinical trial will evaluate the immune-mediated effects of cytokine modulation in combination with CPIs in patients with primary resistance to CPI therapy. The protocol will seek to evaluate the combination of Ampligen and CPIs in patients with advanced urothelial carcinoma, renal cell carcinoma and melanoma. Ampligen is the Company’s investigational immune-enhancing TLR3 agonist that has demonstrated a robust anti-cancer effect in preclinical models when combined with CPIs. This new agreement expands the extensive prior clinical and preclinical work into the clinical checkpoint blockade arena and offers the opportunity to begin evaluation of this combination therapy in patients with a variety of solid tumors where large numbers of patients do not respond or progress following treatment with standard CPI-based therapy.  

The Phase IIa study will be led by Pawel Kalinski, MD, PhD, Vice Chair for Translational Research and Professor of Oncology in the Department of Medicine and Co-Leader of the Tumor Immunology and Immunotherapy Program at Roswell Park, in collaboration with Mateusz Opyrchal, MD, PhD, of the Roswell Park Department of Medicine. Additional details about trial design, implementation and timing will be disclosed upon approval by Roswell Park’s institutional review board.

“This event marks an important milestone for Hemispherx as we evaluate Ampligen in combination with CPIs in difficult-to-treat solid tumors and among a patient population that is largely relapsed and/or refractory to treatment,” said Thomas K. Equels, Chief Executive Officer of Hemispherx. “Our expanded collaboration with Roswell Park offers an ideal setting for these early stage trials. We have developed a productive working relationship with this world-class team and look forward to beginning these important clinical trials.”

About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an immuno-pharma R&D and emerging commercial growth company focused on unmet medical needs in immunology. Hemispherx's flagship products include the Argentina-approved drug rintatolimod (trade names Ampligen® or Rintamod®) and the FDA-approved drug Alferon N Injection®. Based on results of published, peer-reviewed pre-clinical studies and a clinical trial, Hemispherx believes that Ampligen® may have broad-spectrum anti-viral and anti-cancer properties. Clinical trials of Ampligen® already conducted by Hemispherx include studies of the potential treatment of cancer patients with renal cell carcinoma and malignant melanoma. These and other potential uses will require additional clinical trials to generate the safety and effectiveness data necessary to support regulatory approval. Rintatolimod is a double-stranded RNA being developed for globally important debilitating diseases and disorders of the immune system.

About Roswell Park Comprehensive Cancer Center
Roswell Park Comprehensive Cancer Center is a community united by the drive to eliminate cancer’s grip on humanity by unlocking its secrets through personalized approaches and unleashing the healing power of hope. Founded by Dr. Roswell Park in 1898, it is the only National Cancer Institute-designated comprehensive cancer center in Upstate New York. Learn more at www.roswellpark.org, or contact us at 1-800-ROSWELL (1-800-767-9355) or ASKRoswell@RoswellPark.org.

 


Hemispherx to Distribute Second Lot of Ampligen® for use in Multiple Indications in Argentina, the United States and Europe

Source:  Hemispherx Biopharma, Inc. 8/18/18

Ampligen supply will support product launch in Argentina, Expanded Access Programs for the treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome in the United States and Europe and pancreatic cancer in the Netherlands, and upcoming U.S. based Phase I/II combination therapy clinical trials in various solid tumors

Hemispherx Biopharma, Inc. (NYSE American:  HEB) announced today regulatory inspection and clearance for distribution of the Company’s second commercial scale lot of Ampligen® (rintatolimod), which is slated for multiple uses including product launch in Argentina, where Ampligen is approved for the treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), ME/CFS expanded access program (EAP) in the United States and Europe and an EAP in the Netherlands for pancreatic cancer. This lot includes approximately 8,000 vials and is the second such lot filled and finished this year, giving a usable Ampligen supply of approximately 16,000 vials.

Ampligen, a first-in-class drug of large macromolecular RNA (ribonucleic acid) molecules, was approved for commercial sale in Argentina in 2016 for the treatment of ME/CFS, the first therapy ever approved for this quality-of-life impacting disease. The Argentine commercial launch is scheduled for year end and the first quarter of 2019. The Company will also provide Ampligen to medical centers in the U.S. and Europe for use in EAPs for patients with ME/CFS and in the Netherlands for pancreatic cancer. Finally, but significantly, the Company expects to commence additional clinical trials using Ampligen in combination with FDA-approved checkpoint blockade therapies in an effort to improve overall efficacy and survival in cancers such as pancreatic, non-small cell lung, ovarian and colorectal tumors, the first of which may commence within sixty days.

According to the Centers for Disease Control and Prevention, ME/CFS is a serious, long-term illness that affects many body systems. People with ME/CFS are often not able to do their usual activities. At times, ME/CFS may confine them to bed. People with ME/CFS have severe fatigue and sleep problems. ME/CFS may get worse after people with the illness try to do as much as they want or need to do. This symptom is known as post-exertional malaise (PEM). Other symptoms can include problems with thinking and concentrating, pain, and dizziness. According to an Institute of Medicine (IOM) report published in 2015, an estimated 836,000 to 2.5 million Americans suffer from ME/CFS, but most of them have not been diagnosed.

“We are pleased to announce completion of our second commercial size lot of Ampligen and excited about the opportunities availability of the therapy affords us. From a product launch in Argentina, to supporting patients through EAPs and in evaluation for the treatment of solid tumors, we are working to advance Ampligen as rapidly as possible, and realize its potential across multiple market opportunities,” said Thomas K. Equels, Chief Executive Officer of Hemispherx. “While there are millions of ME/CFS patients across the globe, the approval of Ampligen in Argentina represents the first therapy ever approved for treatment of the condition. Additionally, we are hopeful that our initial trials in solid tumor indications will demonstrate the promise of the therapy in combination with checkpoint inhibitors and have a true impact on the cancer treatment paradigm.”

Hemispherx is working to evaluate Ampligen in several cancers, and the current supply of newly filled and finished Ampligen will support the initiation of a Phase I/II study in combination with checkpoint inhibitors in the treatment of solid tumors. The Company is working closely with the internationally acclaimed cancer research centers at Roswell Park, University of Nebraska, and University of Pittsburg to launch these important programs. These planned and imminent clinical trials are based upon pre-clinical animal experiments in which potentially significant combinational synergies were observed. Proof of concept clinical trials have also been conducted in humans to confirm the changes Ampligen creates in the micro-environment of many solid tumors, which are a potential key to improving checkpoint blockade therapy efficacy.

The planned oncology clinical programs follow the recent publication (Cancer Res May 31 2018 DOI: 10.1158/0008-5472.CAN-17-3985) of a head-to-head study in explant culture models that pitted Ampligen against two other TLR3 agonists to measure how each individually might enhance the tumor microenvironment for checkpoint blockade therapy. All three TLR3 agonists activated the TLR3 pathway and promoted an accumulation of killer T cells, but only Ampligen did so without causing attraction of immune suppressive elements, such as regulator T cells. This is a potentially important advantage Ampligen may have over other TLR3 agonists.  Additionally, Ampligen is the only TLR3 agonist with an extensive safety profile showing it to be generally well tolerated in humans. Almost 100,000 doses of intravenous Ampligen have been administered in clinical settings.

About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an immuno-pharma R&D and emerging commercial growth company focused on unmet medical needs in immunology. Hemispherx’s flagship products include Alferon N Injection® and the experimental therapeutic rintatolimod (tradenames Ampligen® or Rintamod®). Rintatolimod is an experimental RNA nucleic acid being developed for globally important debilitating diseases and disorders of the immune system, including immuno-oncology and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). Hemispherx’s platform technology includes components for potential treatment of various severely debilitating and life-threatening diseases. Because rintatolimod is experimental in nature, it is not designated safe and effective by the FDA for general use and is legally available only through clinical trials.

 


Hemispherx Reports Six Months Ended June 30, 2018 Financial Results and Provides Business Update

Source:  Hemispherx Biopharma, Inc. 8/15/18

Hemispherx Biopharma, Inc. (NYSE American:HEB), an immuno-pharma R&D and emerging commercial growth company focused on unmet medical needs in immunology, has announced its financial results for the six months ended June 30, 2018.

The Company has made great progress pursuing Ampligen in combination therapeutic treatments in immuno-oncology. Significant synergistic anti-tumor activity and/or increased median survival has been observed when Ampligen was added to other anti-cancer agents in three pre-clinical studies. As a result, the Company is now working with several top U.S. cancer research centers to initiate Phase 1 and Phase 2 clinical trials combining Ampligen with FDA-approved checkpoint blockade therapies in a variety of solid tumors.

Hemispherx continues to clarify the regulatory pathway for approval of Ampligen to treat CFS in the United States. It expanded its production capabilities in order to provide a reliable supply of Ampligen for all of its clinical and expanded access programs in the U.S., Canada, Europe and commercial program in Argentina. With the ability to produce Ampligen in sizable commercial lots, the Company is laying the foundation for significant revenue growth, as it sees ongoing scientific and medical validation of Ampligen's potential to fill large unmet medical needs in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and a variety of immune-modulated illnesses.

Six Months Ended June 30, 2018 Financial Highlights
As of June 30, 2018, Hemispherx had $4.2 million in cash and cash equivalents, compared to $2.1 million at December 31, 2017. Cash used in operations was $5.2 million for the six months ended June 30, 2018, compared to $5.3 million in the same period in 2017. The net loss was $5.1 million, or $0.13 per share, for the six months ended June 30, 2018, compared to a net loss of $5.0 million, or $0.19 per share, in the same period in 2017.

Ampligen Moving Towards Commercialization
During the quarter, Hemispherx successfully completed the first phase of its Ampligen production plan. The first commercial-sized lot of Ampligen of 8,500 vials passed all required testing for regulatory release for human use. The vials are earmarked for distribution to U.S.-based ME/CFS expanded access programs in Nevada and North Carolina, U.S. clinical trials in immuno-oncology, European and Canadian expanded access programs and for certain testing and validation required for commercial launch in Argentina.

The second commercial-sized lot of Ampligen is currently undergoing release testing and is intended to be available to supply initial demand for Ampligen’s anticipated commercial launch in Argentina, where it is approved for the treatment of severe CFS. The Argentine commercial approval is the first-ever approval of a drug for severe CFS.

About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an immuno-pharma R&D and emerging commercial growth company focused on unmet medical needs in immunology. Hemispherx’s flagship products include Alferon N Injection® and the experimental therapeutic rintatolimod (tradenames Ampligen® or Rintamod®). Rintatolimod is an experimental RNA nucleic acid being developed for globally important debilitating diseases and disorders of the immune system, including Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). Hemispherx’s platform technology includes components for potential treatment of various severely debilitating and life threatening diseases. Because rintatolimod is experimental in nature, it is not designated safe and effective by the FDA for general use and is legally available only through clinical trials.

Hemispherx Files Positive Safety Report on Intranasal Use of Ampligen in Combination with FluMist Influenza Vaccine

Source:  Hemispherx Biopharma, Inc. 7/9/18

Hemispherx Biopharma, Inc. (NYSE American:HEB) announced the filing of a clinical study report on AMP-600, a Phase I/II trial of intranasal Ampligen® in combination with FluMist® influenza vaccine with the U.S. Food and Drug Administration. Hemispherx is a research and development and, consistent with its commercial and early access program approvals, an emerging commercial development company focused on unmet medical needs in immunology, with a special emphasis in immuno-oncology.

The two-stage randomized, double-blinded, placebo-controlled, clinical trial assessed the immunogenicity and safety of intranasal FluMist administered sequentially with intranasal Ampligen. The report indicates that there was no evidence of any increase in adverse effects related to higher dosage levels of Ampligen or to the continued administration of Ampligen during the second and third dual vaccinations. The intranasal use of Ampligen and FluMist was generally well-tolerated and generated antibodies against influenza subtypes not present in the seasonal vaccine.

In February 2018, the U.S. Centers for Disease Control and Prevention Advisory Committee on Immunization Practices voted in favor of renewing its recommendation for the use of FluMist Quadrivalent vaccine for the prevention of influenza during the 2018-2019 flu season.

Pre-clinical studies of Ampligen in combination with seasonal influenza vaccines indicate the intranasal combination could be highly effective in vivo against both seasonal and avian influenza A viruses (H5N1) and 3 H5N1 clades.  H5N1 is proven to be highly lethal in humans and has the mutagenic potential for pandemic transmission. In both preclinical and clinical studies, the intranasal combination of seasonal vaccine and Ampligen was observed to generate cross reactive antibodies, which could extend or preserve vaccine efficacy as viruses mutate.

About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an immuno-pharma R&D and emerging commercial growth company focused on unmet medical needs in immunology. Hemispherx's flagship products include the Argentina-approved drug rintatolimod (trade names Ampligen® or Rintamod®) and the FDA-approved drug Alferon N Injection®. Based on results of published, peer reviewed pre-clinical studies and clinical trials, Hemispherx believe that Ampligen® may have broad-spectrum anti-viral and anti-cancer properties. Clinical trials of Ampligen® already conducted by Hemispherx include studies of the potential treatment of cancer patients with renal cell carcinoma and malignant melanoma, CFS, Hepatitis B and HIV. All of these potential uses will require additional clinical trials to generate the safety and effectiveness data necessary to support regulatory approval. Rintatolimod is a double-stranded RNA being developed for globally important debilitating diseases and disorders of the immune system. Commercialization of Ampligen® in Argentina will require, among other things, an appropriate reimbursement level, appropriate marketing strategies, completion of manufacturing preparations for launch (including possible requirements for approval of final manufacturing) and we most likely will need additional funds to manufacture product at a sufficient level for a commercial launch.

Hemispherx Opens FDA-Approved Reimbursement Based Expanded Access Treatment Program for ME/CFS to New Enrollees at Approved Clinical Sites in Nevada and North Carolina

Source:  Hemispherx Biopharma, Inc. 6/27/18

Hemispherx Biopharma, Inc. (NYSE American:HEB) has announced the immediate expansion of its Treatment Protocol/Expanded Access Programs for ME/CFS in the United States, known as AMP-511, to new enrollees for the first time in more than a year. This opportunity to expand the scope of AMP-511 is based on the successful completion of the first phase of its Ampligen manufacturing initiative producing sufficient quantities of Ampligen to support new enrollees in this FDA-approved program. Additional enrollees will be added as supplies of Ampligen expand with the successful fill and finish of additional commercial-sized lots similar to the 8,500 vials just released for human use. However, due to the nature of the limitations in such FDA-approved programs, the number of enrollees will always be limited.

The two approved sites are the Hunter-Hopkins Center in Charlotte, North Carolina and Sierra Internal Medicine in Incline Village, Nevada.

Charles W. Lapp, MD, Principal Investigator at Hunter-Hopkins Center stated “Hunter-Hopkins Center is delighted to hear that the compassionate care program for Ampligen/rintatolimod will once again be welcoming new subjects.”

Daniel Peterson, MD, Principal Investigator at Sierra Internal Medicine stated “We are very enthusiastic about the recent communication from Hemispherx Biopharma announcing the immediate compassionate care protocol expansion.”

Hemispherx announced on June 3, 2018, that its first commercial sized lot of Ampligen, consisting of 8,500 vials, had passed all required testing for regulatory release for human use. “We view the compassionate care program as just a band aid for a much larger problem.  We estimate over one hundred thousand people are now fully disabled in the United States due to ME/CFS. This incapacitating unmet medical need should be aggressively addressed by providing therapeutic options, just as the FDA did when it successfully addressed the AIDS crisis years ago,” said Thomas K. Equels, Chief Executive Officer of Hemispherx. “This successfully released batch of Ampligen will be utilized to expand our ME/CFS compassionate care programs in Nevada and North Carolina and our expanded Early Access Program in Europe in pancreatic cancer, as well as for important immuno-oncology clinical studies in the United States. These studies will include Phase I/II studies of Ampligen in combination with checkpoint blockade drugs in a variety of solid tumor cancers.”

About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an immuno-pharma R&D and emerging commercial growth company focused on unmet medical needs in immunology. Hemispherx's flagship products include the Argentina-approved drug rintatolimod (trade names Ampligen® or Rintamod®) and the FDA-approved drug Alferon N Injection®. Based on results of published, peer reviewed pre-clinical studies and clinical trials, Hemispherx believe that Ampligen® may have broad-spectrum anti-viral and anti-cancer properties. Clinical trials of Ampligen® already conducted by Hemispherx include studies of the potential treatment of cancer patients with renal cell carcinoma and malignant melanoma, CFS, Hepatitis B and HIV. All of these potential uses will require additional clinical trials to generate the safety and effectiveness data necessary to support regulatory approval. Rintatolimod is a double-stranded RNA being developed for globally important debilitating diseases and disorders of the immune system. Commercialization of Ampligen® in Argentina will require, among other things, an appropriate reimbursement level, appropriate marketing strategies, completion of manufacturing preparations for launch (including possible requirements for approval of final manufacturing) and we most likely will need additional funds to manufacture product at a sufficient level for a commercial launch.


Hemispherx Announces New Data Showing Ampligen’s Positive Role in Reprograming Tumor Microenvironment

Source:  Hemispherx Biopharma, Inc. 6/5/18

Study Results Suggests Ampligen Could Materially Enhance the Effectiveness of Checkpoint Blockade Technology

Hemispherx Biopharma, Inc. (NYSE American:HEB) announced today that its TLR3 agonist Ampligen outperformed two other TLR3 agonists, poly IC and natural double stranded RNA, in creating an enhanced tumor microenvironment for checkpoint blockage therapy. Hemispherx is an advanced specialty pharmaceutical company engaged in the treatment of serious and debilitating disorders.

In a head-to-head study in explant culture models, Ampligen activated the TLR3 pathway and promoted an accumulation of killer T cells but, unlike the other two TLR3 agonists, it did so without causing regulatory T cell (Treg) attraction. These findings are considered important because they show that Ampligen selectively reprograms the tumor microenvironment by inducing the beneficial aspects of tumor inflammation (attracting killer T cells), without amplifying immune suppressive elements such as regulator T cells. The study, conducted at the University of Pittsburgh and Roswell Park Comprehensive Cancer Center, as a part of the NIH-funded P01 CA132714 and Ovarian Cancer Specialized Program of Research Excellence (SPORE), was published online in the journal Cancer Research (http://cancerres.aacrjournals.org/content/early/2018/05/31/0008-5472.CAN-17-3985).

“This has the potential to be clinically significant because a robust killer T cell population in the tumor microenvironment without attraction of Treg cells is important to help optimize checkpoint blockade-induced tumor shrinkage.” said Robert P. Edwards MD, executive vice chair of gynecologic services at Magee-Womens Hospital of UPMC and Professor of Obstetrics, Gynecology & Reproductive Services, University of Pittsburgh School of Medicine.

Lead investigator Pawel Kalinski, MD, PhD, Vice Chair for Translational Research and Professor of Oncology, Department of Medicine at Roswell Park, commented that the study “provides a strong foundation for moving forward with solid tumor studies to clinically demonstrate the extent to which Ampligen reprograms the tumor microenvironment in various clinical settings, with the goal of developing more effective immune therapies with checkpoint blockers.”

“We believe this is a valuable survival-enhancing medical strategy, building on the known capability of immuno-oncology agents such as Keytruda and Opdivo and potentially giving them a significant boost in tumor killing activity” said Thomas K. Equels, Chief Executive Officer of Hemispherx.

About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the clinical development of new drug entities for the treatment of serious and debilitating disorders. Hemispherx's flagship products include the FDA-approved drug Alferon N Injection® and the Argentina-approved drug rintatolimod (tradenames Ampligen® or Rintamod®). Rintatolimod is a double-stranded RNA being developed for globally important debilitating diseases and disorders of the immune system, including Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). Hemispherx's platform technology includes components for the potential treatment of various severely debilitating and life-threatening diseases. Because rintatolimod has not been designated safe and effective by the FDA for general use, it is legally available in the United States only through clinical trials; however, Ampligen® has been approved in Argentina for severe ME/CFS. The company is working toward legal access in other countries where early access programs exist for serious diseases, such as ME/CFS, with unmet medical needs. Ampligen® is the only therapy approved anywhere in the world for ME/CFS. An Ampligen® EAP approval has also been obtained for therapeutic use in the Netherlands for pancreatic cancer.

 


Hemispherx Biopharma and Roswell Park Plan Phase I/II Study of Ampligen Plus Checkpoint Inhibitors





Source:  Hemispherx Biopharma, Inc. 5/31/18

Earlier Studies Showed Ampligen Produced a More Favorable Ratio of Killer T cells to Regulatory T cells in the Tumor Microenvironment, a Key to Improving Checkpoint Blockade Therapy

Roswell Park Comprehensive Cancer Center (Roswell Park) and Hemispherx Biopharma, Inc. (NYSE American:HEB) plan to expand their existing scientific collaboration to advance the clinical development of Ampligen – an investigational immune-enhancing TLR3 agonist – which has shown promise in preclinical studies when combined with checkpoint inhibitors (CPIs). The parties have executed a Memorandum of Understanding (“MOU”) designed to further assess the clinical potential of Ampligen in treating certain cancers.

A contemplated phase I/II study will evaluate the potential of Ampligen to enhance the immune mediated effects of CPIs in patients with advanced solid tumors. The study will seek to validate prior research that has demonstrated synergy with this combination in preclinical models. This study will be led by Pawel Kalinski, MD, PhD, who currently serves as the Vice Chair for Translational Research and Professor of Oncology in the Department of Medicine and as the Co-Leader for the Tumor Immunology & Immunotherapy Program at Roswell Park.

“Earlier clinical data demonstrated significant activity against metastatic renal cell carcinoma and melanoma. More recent preclinical studies combining Ampligen with checkpoint inhibitors have yielded very promising results,” said David Strayer, MD, Chief Scientific Officer of Hemispherx. “The objective now is to determine the optimal integration of Ampligen with standard checkpoint inhibitor therapy in the clinic in a variety of solid tumors with the goal of improving survival.”

“Enhancing the accumulation of cytotoxic T cells and enhancing their activation levels in the tumor microenvironment, as Ampligen has demonstrated in recent preclinical studies, is critically important to improving the effectiveness of PD1-targeted checkpoint inhibitors,” said Dr. Pawel Kalinski. “We are excited to expand our collaboration with Hemispherx and to embark on a clinical study designed to assess the promise of Ampligen in combination with checkpoint inhibitors across a variety of advanced solid-tumor settings.”

“We are delighted Roswell Park is expanding its collaborations with Hemispherx to study the combination of Ampligen and checkpoint inhibitors with a goal to improve and prolong the lives of people with advanced solid tumors,” said Thomas K. Equels, Chief Executive Officer of Hemispherx. “Finding ways to explore the full potential of Ampligen as an immune-enhancing therapy in combination with checkpoint inhibitors is one of our top priorities.”

About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx’s flagship products include FDA approved Alferon N Injection®, the only natural alpha-interferon product, and the ANMAT (Argentina) approved product for severe myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) known as rintatolimod (tradenames Ampligen® or Rintamod®). Outside of Argentina, Rintatolimod is an experimental RNA nucleic acid being developed for globally important debilitating diseases and disorders of the immune system, with a priority focus on solid tumor malignancies. Based on experience to date in ME/CFS, with nearly 100,000 doses administered intravenously (IV) to human subjects in clinical settings, Rintatolimod has been generally well tolerated. Due to the fact that Rintatolimod is experimental in nature, it is not designated safe and effective by the FDA for general use and is legally available only through clinical trials.
About Roswell Park Comprehensive Cancer Center
Roswell Park Comprehensive Cancer Center is a community united by the drive to eliminate cancer’s grip on humanity by unlocking its secrets through personalized approaches and unleashing the healing power of hope. Founded by Dr. Roswell Park in 1898, it is the only National Cancer Institute-designated comprehensive cancer center in Upstate New York. Learn more at www.roswellpark.org, or contact us at 1-800-ROSWELL (1-800-767-9355) or ASKRoswell@RoswellPark.org.

 

Hemispherx Successfully Completes Production of More Than 8,500 Vials of Ampligen for Commercial Sales and Expanded Clinical Programs





 Source:  Hemispherx Biopharma, Inc. 4/17/18


Hemispherx Biopharma, Inc. (NYSE American:HEB), an immuno-pharma R&D and emerging commercial growth company focused on unmet medical needs in immunology, is pleased to announce that it has successfully achieved a developmental milestone with the completed production of a commercial-size batch of more than 8,500 vials of Ampligen®, its drug candidate that has been accorded Orphan Drug Product Designation by the FDA for the treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). The Company announced that following its “Fill & Finish” at the Contract Manufacturing Organization (CMO), the batch is now undergoing routine release testing prior to shipment.

ME/CFS is a chronic and disabling biological disorder affecting millions worldwide. The direct and indirect economic costs of ME/CFS in the United States have been estimated at $17 to $24 billion per annum (Jason et al., 2008), $9.1 billion of which has been attributed to lost household and labor force productivity (Reynolds et al., 2004). There are no approved treatments for ME/CFS in the United States. Ampligen is the only drug in late-stage clinical development.

Hemispherx plans to generate substantial revenues from this large batch through an existing 2,100 vial stock order from myTomorrows for its early access programs. Further, this batch will supply the initial demand for the anticipated commercial launch of Ampligen in Argentina, where it is approved for treatment of severe ME/CFS. The recent Argentine approval is the first-ever approval of a drug for severe ME/CFS. Additionally, this large lot meets the Company’s projected needs for clinical trials of Ampligen in the United States, including the FDA-approved compassionate care program in ME/CFS, and clinical trials involving various cancers with Ampligen as a stand-alone therapy as well as in combination with checkpoint blockade technology.

“This accomplishment is an important milestone for Hemispherx. Team Hemispherx has demonstrated it can compound its polymers into filled and finished commercial-size lots, thereby setting the ground for dramatically expanding revenues in the coming months. Additional commercial-sized lots are scheduled and we are moving full speed ahead,” said Thomas K. Equels, Chief Executive Officer of Hemispherx. “This further demonstrates our ability to produce commercial-scale lots of Ampligen, thereby paving the way to better serve those with dire unmet medical needs.”

Hemispherx announced in January 2018 that it had polymers, equivalent to approximately 18,000 vials of Ampligen, ready to compound fill and finish at its CMO. The more than 8,500 vials recently successfully filled and finished at our CMO were derived from a portion of these polymers.

About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx’s flagship products include the FDA approved drug Alferon N Injection® and the Argentina approved drug rintatolimod (tradenames Ampligen® or Rintamod®). Rintatolimod is a RNA nucleic acid being developed for globally important debilitating diseases and disorders of the immune system, including Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). Hemispherx’s platform technology includes components for potential treatment of various severely debilitating and life threatening diseases. Because rintatolimod has not been designated safe and effective by the FDA for general use, it is legally available in the United States only through clinical trials, however, Ampligen has been approved in Argentina for ME/CFS and the company is working toward legal access in other countries where early access programs exist for serious diseases such as ME/CFS where there are unmet medical needs. Ampligen is the only therapy approved anywhere in the world for ME/CFS. Also, an Ampligen EAP approval has been obtained for therapeutic use in the Netherlands for pancreatic cancer.

Hemispherx Expands Ampligen Early Access Programme to Canada to Treat ME/CFS Patients


 Source:  Hemispherx Biopharma, Inc. 4/4/18

Early Access Programs are Known as “Special Access Programme” in Canada

Hemispherx Biopharma, Inc. (NYSE American:HEB), focused on pharmaceutical research, said it amended its agreement with Netherlands-based myTomorrows to include management of a Special Access Programme (SAP) in Canada for patients suffering from Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).

myTomorrows, Hemispherx’s exclusive service provider for early access programs in Europe and Turkey, will now also perform special access activities in Canada to include managing the supply of Ampligen®  for the treatment of ME/CFS, for which there is currently no approved product in Canada. Ampligen is approved only in Argentina for severe ME/CFS. Hemispherx has a NDA on file with the U.S. FDA and is developing a protocol for a confirmatory Phase 3 trial.

The first commercial size batch of Ampligen, which will contain ~8,300 vials, is anticipated to be available in May. This is the first of several lots scheduled over the next 18 months. We have recently received a stock order from myTomorrows for 2,100 vials that will be allocated from the first lot of Ampligen produced.  

The Canadian SAP will be supported by Millions Missing Canada, a non-profit organization advocating for ME/CFS research funding and treatment access in Canada, which is working with Hemispherx to establish a pathway for government approval of Ampligen for ME/CFS in Canada.

“This is long overdue, and we are delighted myTomorrows is expanding its role with us into Canada to provide a greatly needed option for Canadians suffering the debilitating effects of ME/CFS,” said Thomas K. Equels, CEO of Hemispherx. “Millions Missing Canada brings a strong advocacy and outreach to this program as an invaluable partner in advancing treatments for ME/CFS patients.”

Scott Simpson, an ME patient and advocate with Millions Missing Canada said, "With over 580,000 Canadians diagnosed with ME, and experiencing the highest rates of unmet health care needs according to Health Canada, access to Ampligen is our greatest hope for treatment. For over 3 decades there have been millions of dollars missing from ME research and treatment in Canada, now Canadians living with ME may have a treatment option through the Special Access Program and we are keen to collaborate with Hemispherx and myTomorrows to make that opportunity become a reality. We may get our health, and lives, back."

About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx’s flagship products include Alferon N Injection® and the experimental therapeutic rintatolimod (tradenames Ampligen® or Rintamod®). Rintatolimod is an experimental RNA nucleic acid being developed for globally important debilitating diseases and disorders of the immune system, including Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). Hemispherx’s platform technology includes components for potential treatment of various severely debilitating and life threatening diseases. Because rintatolimod is experimental in nature, it is not designated safe and effective by the FDA for general use and is legally available only through clinical trials.

 


Tuesday, November 6, 2018

Arch Therapeutics Announces 510(k) Submission to the U.S. FDA for AC5™ Topical Gel





Source:  Arch Therapeutics, Inc. 10/1/18


Arch Therapeutics, Inc. (OTCQB: ARTH) (“Arch” or the “Company”), developer of novel liquid, gel and solid hemostatic and wound care devices, today announced that the Company submitted a 510(k) notification to the U.S. Food and Drug Administration (FDA or “the Agency”) for its AC5ä Topical Gel (AC5)1 and has received acknowledgement from the Agency that the submission has been received.

The purpose of the 510(k) notification is to allow for commercial use of AC5 on external wounds for the management of partial and full-thickness wounds, such as pressure sores, leg ulcers, diabetic ulcers, and surgical wounds.

Terrence W. Norchi, MD, President and CEO of Arch, said, “We are happy to have initiated and completed the necessary steps required to file this submission during the third calendar quarter. As previously disclosed, these steps included developing a required study protocol and submitting it to the Agency in a pre-submission letter in the first calendar quarter, completing the pre-submission process and initiating the study in the second calendar quarter, and completing the study and filing the 510(k) during the third and most recent calendar quarter.”

As previously disclosed, the Company plans to file a CE Mark for external use of AC5 this calendar year, to subsequently seek regulatory approval for expanded indications, and to pursue internal use commercial opportunities for other AC5-related products through the premarket authorization process. Arch continues to evaluate commercialization options and will provide updates when appropriate.

About Arch Therapeutics, Inc.Arch Therapeutics, Inc. is a biotechnology company developing a novel approach to stop bleeding (hemostasis), control leaking (sealant) and manage wounds during surgery, trauma and interventional care. Arch is developing products based on an innovative self-assembling barrier technology platform with the goal of making care faster and safer for patients. Arch's development stage product candidates include the AC5™ Topical Gel and the AC5™ Surgical Hemostatic Device.

Arch Therapeutics Reports Topline Results from Skin Sensitization Study of AC5





Source:  Arch Therapeutics, Inc. 9/5/18


Study finds no evidence of irritation or allergic reaction in any enrolled subject


 

Arch Therapeutics, Inc. (OTCQB: ARTH) ("Arch" or the "Company"), developer of liquid, gel and solid hemostatic and wound care devices, today announced topline data for its irritation/sensitization patch test study of AC5™ Topical Gel (AC5)1. The study was designed to address a request by the Food and Drug Administration (FDA or “the Agency”).

These topline results indicate that AC5 is neither an irritant nor a sensitizer. Additionally, no immunogenic response and no serious or other adverse events attributable to the device were reported in any of the enrolled subjects.

The objective of this Study (“Cumulative Irritancy Assay with Delayed Challenge for Allergic Contact Dermatitis Potential of AC5™ Topical Gel (AC5) in Healthy Volunteers”) was to assess irritation and sensitization potential (development of allergic contact dermatitis) of AC5 after repeat applications and then a delayed challenge application of the product to the skin. Products can be studied in this way to determine if a reaction develops immediately upon initial exposure to the skin, in the case of irritation, or when the skin is ‘challenged’ or exposed again at a point in the future, in the case of allergic contact dermatitis.

Terrence W. Norchi, MD, President and CEO of Arch, said, “We are pleased that these topline results provide favorable support for the safety profile of AC5, and we are eager to provide the full report to the FDA. As previously indicated, this study is intended to strengthen and enhance the Company’s 510(k) notification for AC5 Topical Gel, which we expect to file during this third quarter of calendar 2018, as previously disclosed.”

About Arch Therapeutics, Inc.
Arch Therapeutics, Inc. is a biotechnology company developing a novel approach to stop bleeding (hemostasis), control leaking (sealant) and manage wounds during surgery, trauma and interventional care. Arch is developing products based on an innovative self-assembling barrier technology platform with the goal of making care faster and safer for patients. Arch's development stage product candidates include AC5™ Topical Gel and AC5™ Surgical Hemostatic Device.

Arch Therapeutics Appoints Healthcare Industry Executive Punit Dhillon to Board of Directors





Source:  Arch Therapeutics, Inc. 7/20/18


Medical device and biopharma drug development, M&A experience enhance Arch

Arch Therapeutics, Inc. (OTCQB:ARTH) (“Arch” or the “Company”), developer of the AC5 Surgical Hemostatic Device™ (“AC5™”), today announced the appointment of Punit Dhillon, former President & CEO of OncoSec Medical, Inc. (NASDAQ:ONCS), to its Board of Directors (the “Board”) as an independent member effective as of July 19, 2018. Mr. Dhillon brings over 15 years of global industry experience to Arch’s Board with a wealth of knowledge and experience operationally in medical devices, advancing programs from scientific research through clinical development, regulatory approval, and into healthcare systems globally. Mr. Dhillon is experienced and skilled in capital markets and in establishing strategic partnerships, including early and late stage deals with Merck and Pfizer.

Mr. Dhillon co-founded OncoSec, a biotechnology company pioneering new technologies to stimulate the body’s immune system to target and attack cancer. Prior to that, Mr. Dhillon served as Vice President of Finance and Operations at Inovio Pharmaceuticals, Inc. (formerly Inovio Biomedical Corporation), a DNA vaccine development company, from September 2003 until March 2011.  Mr. Dhillon is also currently a director for Emerald Health Sciences, Inc. and Audit Committee Chair of Emerald Health Therapeutics, Inc. (TSXV:EMH) and Nemus Bioscience, Inc. (OTCQB:NMUS).

Mr. Dhillon said, “Having led or supported numerous companies in the healthcare industry in North America and Europe, I understand the importance of technological innovation to advancing the state of care across a range of therapeutic areas. I am convinced that the technology being developed by Arch holds the potential to improve an impressive array of surgical procedures and fulfill many poorly met needs. I look forward to working with the Board as Arch continues its development path through clinical studies with the goal of commercializing its products.”

Dr. Terrence Norchi, added, “Punit Dhillon brings a tremendous amount of industry experience to Arch, and we intend to draw heavily on his insights and professional talents. His executive leadership with public companies contributes to his exceptional qualifications. Punit will provide valuable advice and support as we contemplate potential commercial partnership opportunities.”

Mr. Dhillon will be filling the position formerly held by Avtar Dhillon, MD (“Dr. Dhillon”), the Chairman of Arch’s Board.  Dr. Dhillon submitted his resignation from the Board on July 17, 2018, which became effective on July 19, 2018, but will continue to serve as an advisor to the Company. Dr. Norchi will succeed Dr. Dhillon as the Chairman of the Board in addition to his role as President & CEO.  “Dr. Dhillon has been and continues to be a committed resource and advisor to me and to the Company,” said Terrence W. Norchi, MD, President, CEO and Chairman of Arch Therapeutics, Inc. “I am thankful and appreciative of the leadership and counsel of Avtar and look forward to his continuing support as we move our technology and products forward. I know that he will remain as accessible and helpful as always. We look forward to continuing work with the Board, our advisors and the rest of our team in the drive to building value.”

Mr. Dhillon is the nephew of Dr. Dhillon, and is also a member of the board of directors of OncoSec Medical Inc. and Emerald Health Sciences, Inc, both of which are companies for which Dr. Dhillon is the chairman of the board.

About Arch Therapeutics, Inc.
Arch Therapeutics, Inc. is a biotechnology company developing a novel approach to stop bleeding (hemostasis), control leaking (sealant) and manage wounds during surgery, trauma and interventional care. Arch is developing products based on an innovative self-assembling barrier technology platform with the goal of making care faster and safer for patients. Arch's development stage product candidates include the AC5™ Topical Gel and the AC5™ Surgical Hemostatic Device.

 

Arch Therapeutics, Inc. $4.5 Million Registered Direct Offering





Source:  Arch Therapeutics, Inc. 6/29/18


Arch Therapeutics, Inc. (OTCQB:ARTH) (“Arch” or the “Company”), a developer of innovative materials as hemostatic and wound care devices, today announced the pricing of registered direct offering of 9.1 million units, each unit consisting of a share of the Company’s common stock, and a Series G Warrant (“Series G Warrant”) to purchase 0.75 of a share of our common stock for the combined purchase price of $0.50 per unit.  The Series G Warrants have an exercise price of $0.70 per share and are exercisable for a period of five years.

The gross proceeds to Arch from this offering are approximately $4.5 million before deducting estimated offering expenses payable by the Company. The offering is expected to close on or about July 2, 2018, subject to customary closing conditions.

The securities described above are being offered by Arch pursuant to a registration statement previously filed with and subsequently declared effective by the Securities and Exchange Commission (“SEC”) (File Number 333- 213878) on October 20, 2016. A final prospectus supplement relating to the offering will be filed with the SEC and, once filed, will be available on the SEC’s website at http://www.sec.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Arch Therapeutics, Inc.
Arch Therapeutics, Inc. is a biotechnology company developing a novel approach to stop bleeding (hemostasis), control leaking (sealant) and manage wounds during surgery, trauma and interventional care. Arch is developing products based on an innovative self-assembling barrier technology platform with the goal of making care faster and safer for patients. Arch's development stage product candidates include the AC5™ Topical Gel and the AC5™ Surgical Hemostatic Device.

Arch Therapeutics Provides Skin Sensitization Study Status Update

Source:  Arch Therapeutics, Inc. 6/26/18

Approximately two-thirds of applications in the repeat dosing induction phase are completed; Study remains on track

Arch Therapeutics, Inc. (OTCQB: ARTH) ("Arch" or the "Company"), developer of liquid, gel and solid hemostatic and wound care devices, provided an update today in which it announced that in the recently initiated skin sensitization study of AC5TM Topical Gel (AC5), two-thirds of the applications of AC5 in the repeat dosing induction phase have occurred and the study remains on schedule.

The sensitization study protocol was designed by Arch and its subject matter experts, and it incorporates recommendations provided by the Food and Drug Administration (FDA or “the Agency”). The study, designed as a single-center, prospective, clinical investigation, in approximately 50 healthy subjects, comprises an induction phase separated from a challenge phase by a rest period.

During the induction phase, AC5 on a patch is applied to each subject’s back three times weekly over 21 days for a total of 9 applications. With each re-application, the skin beneath the patch is evaluated, and any findings are scored per protocol. After a 14-day rest period, subjects enter the challenge phase, receive one additional application of AC5, and after a two-day rest period, are evaluated over 48 hours. If significant positive reactions occur subjects may be re-challenged in order to provide further information.

The Company is pleased to report that two-thirds of the induction phase applications have been completed and the study remains on schedule to conclude in the third calendar quarter of 2018.
Terrence W. Norchi, MD, President and CEO of Arch, said, “While the study and report must be completed before we can draw conclusion, we remain optimistic about the outcome based on the results of the prior study for sensitization that was performed in animals. We are also pleased that the study remains on budget, and we now anticipate that our corporate cash runway has extended into the fourth calendar quarter of 2018.”

The study is intended to support the Company’s 510(k) notification for its AC5 Topical Gel, which is expected to be filed by the end of the third quarter of calendar 2018.

About Arch Therapeutics, Inc.
Arch Therapeutics, Inc. is a biotechnology company developing a novel approach to stop bleeding (hemostasis), control leaking (sealant) and manage wounds during surgery, trauma and interventional care. Arch is developing products based on an innovative self-assembling barrier technology platform with the goal of making care faster and safer for patients. Arch's development stage product candidates include the AC5™ Topical Gel and the AC5™ Surgical Hemostatic Device.

 


Arch Therapeutics Completes Enrollment and Initiates Dosing in Skin Sensitization Study

 Source:  Arch Therapeutics, Inc. 6/15/18

Study completion and submission of 510(k) notification expected in Calendar Q3 2018

Arch Therapeutics, Inc. (OTCQB:ARTH) ("Arch" or the "Company"), developer of liquid, gel and solid hemostatic and wound care devices, announced today that it has completed enrollment for its human skin sensitization study and that applications of the Company’s AC5™ Topical Gel are underway for all subjects. The study is anticipated to conclude during the third quarter. 

Terrence W. Norchi, MD, President and CEO of Arch, said, "This study is an important component of our plans to address the request by the Food and Drug Administration (FDA or “the Agency”). The Agency had requested further evidence beyond that which was previously supplied to support that AC5 does not cause sensitization in humans. We are pleased that enrollment was completed within the expected timeframe and that the study volunteers have entered the repeat dosing phase.”

The study protocol was designed with input from Arch’s expert advisors and the Agency in order to support the Company’s 510(k) submission for its AC5™ Topical Gel. As previously announced, the study is expected to cost approximately $100,000 and take about three months. We anticipate filing a 510(k) notification by the end of the third quarter of calendar 2018.

Dr. Norchi added, “We expect the future anticipated 510(k) notification to contain both the information previously reviewed by the FDA, including the favorable results from a required animal test for sensitization, and the additional data from this human sensitization study. We believe that there are no other material items to address with the Agency.”

As the study is conducted, Arch remains focused on manufacturing scale-up, clinical regulatory strategy, developing commercial partnerships, enhancing its intellectual property portfolio and expanding its pipeline of products.

About Arch Therapeutics, Inc.
Arch Therapeutics, Inc. is a biotechnology company developing a novel approach to stop bleeding (hemostasis), control leaking (sealant) and manage wounds during surgery, trauma and interventional care. Arch is developing products based on an innovative self-assembling barrier technology platform with the goal of making care faster and safer for patients. Arch's development stage product candidates include the AC5™ Topical Gel and the AC5™ Surgical Hemostatic Device.

 


Sunday, November 4, 2018

Citius Provides Clinical Update And Progress Of The Mino-Lok® Phase 3 Trial



Source:  Citius Pharmaceuticals, Inc. 7/9/18

PIVOTAL TRIAL ASSESSES THE EFFECTIVENESS AND SAFETY OF MINO-LOK IN THE TREATMENT OF INDIVIDUALS WITH CATHETER RELATED BLOOD STREAM INFECTIONS (CRBSIs)

Citius Pharmaceuticals, Inc. ("Citius") ("Company") (NASDAQ: CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, provided a status report on the progress of the Mino-Lok Phase 3 clinical program. The Mino-Lok Phase 3 Trial is planned to enroll 700 patients in 50 participating institutions, all located in the U.S. There will be interim analyses at the 50% and 75% point of the trial as measured by the number of patients treated.


Citius reports that as of this past week there are 12 active sites currently enrolling patients including such academic centers as MD Anderson Cancer Center, Henry Ford Health Center, Georgetown University Medical Center, University of Chicago, and others. There are 13 additional well renowned medical centers in startup mode. When these study centers are activated, site recruitment will have reached 50% of the target institutions planned; and, there are another 13 centers in feasibility stage.

"We have pre-screened over 328 patients with CRBSIs in a short period of time demonstrating that these infections continue to be highly prevalent and present a significant unmet need. Although our patient recruitment is slower than initially planned, we have adjusted the inclusion/exclusion criteria to be able to enroll patients at a greater rate. In addition we have deployed experienced clinical research associates to ensure that medical staff in the participating institutions are aware of this study that could benefit their patients and shed light on alternatives to removing and replacing infected central lines in very sick patients. We expect to have all 50 sites activated in this quarter (Q3 2018)," said Myron Holubiak, President and CEO of Citius. "This will be the largest and most definitive study of its kind conducted to date. Because of the unique properties of Mino-Lok, we believe we will be able to show that Mino-Lok therapy, used in a very manageable dosing regimen, namely two hours of lock time for 5 to 7 days, is superior to any other antibiotic locks that require substantially more dwell time and have not been thoroughly studied. Mino-Lok would be the first approved antibiotic lock for the treatment of CRBSIs. The Company thanks all of its advisors and partners for their help in bringing Mino-Lok to the clinic."

Catheter Related Bloodstream Infections ("CRBSIs") are some of the most difficult infections to treat, and, are a leading cause of healthcare-associated infections (HAIs) with substantial morbidity and mortality. Patients with CRBSI may be at risk for serious complications, including septic thrombosis, endocarditis, and disseminated infection. Many of these patients need to have their central venous catheters removed and subsequently replaced, causing added costs, morbidities and discomfort. Removal and reinsertion of a new CVC may be difficult or even impossible due to the unavailability of other accessible vascular sites. Furthermore, critically ill patients often have underlying coagulopathy, which may increase the risk of mechanical complications (e.g., hemopneumothorax, misplacement, or arterial puncture with severe hematomas and attendant blood loss) with the reinsertion of a new catheter at a different site.

About the Mino-Lok TrialThe Mino-Lok trial is a Phase 3, Multi-Center, Randomized, Open-Label, Assessor-Blind Study to Evaluate the Efficacy and Safety of Mino-Lok Therapy (MLT) in Combination with Systemic Antibiotics in the Treatment of Catheter-Related Bloodstream Infections.
Subjects with documented CRBSI for whom catheter retention is reasonable or required due to lack of alternative venous access will be included.
The primary endpoint for this study is the proportion of subjects who have Overall Success at the test of cure at week 8.
Overall Success is defined as a subject who does NOT demonstrate ANY of the following:
  • All-cause mortality at Week 8;
  • Catheter removal for any infection-related reason or inability to administer study drug;
  • Worsening of systemic signs and symptoms of infection that result in discontinuation of lock therapy;
  • Demonstration that the baseline pathogen is not eradicated from the blood at 48 hours following randomization despite 48 hours of antibiotic therapy to which the infecting organism is susceptible;
  • Demonstration that the baseline pathogen has recurred by Week 8 of the study; or,
  • Demonstration that the baseline pathogen is part of a newly diagnosed deep-seated infection by Week 8 of the study.
Mino-Lok® is under investigation and not approved for commercial use.

About Citius Pharmaceuticals, Inc.Citius is a specialty pharmaceutical company dedicated to the development and commercialization of critical care products, with a focus on anti-infectives, cancer care and unique prescription products that use innovative, patented or proprietary formulations of previously-approved active pharmaceutical ingredients. We seek to achieve leading market positions by providing therapeutic products that address unmet medical needs; by using previously approved drugs with substantial safety and efficacy data, we seek to reduce the risks associated with pharmaceutical product development and regulatory requirements. Citius develops products that have intellectual property protection and competitive advantages to existing therapeutic approaches. For more information, please visit www.citiuspharma.com.


Citius Announces The Issuance Of The Patent On The Advanced Stability Of Mino-Lok® By USPTO





Source:  Citius Pharmaceuticals, Inc. 9/25/18

Citius Pharmaceuticals, Inc. ("Citius") ("Company") (NASDAQ: CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, received notice from MD Anderson Cancer Center ("MDACC") that the US Patent and Trademark Office ("USPTO") will issue United States Patent Number 10/086,114 entitled "Antimicrobial Solutions with Enhanced Stability" on October 2, 2018.


The new invention overcomes limitations in mixing antimicrobial solutions in which components have precipitated because of physical and/or chemical factors, thus limiting the stability of the post-mix solutions. The scientists and technologists at MDACC have been able to improve the stability of the post-mixed solutions through adjustments of the post-mixed pH of the solution. This may allow for longer storage time of the ready-to-use solution.

Citius holds the exclusive worldwide license to this patented technology.

"We are thrilled that this patent is being issued as it extends our intellectual property protection on Mino-Lok significantly to November 4, 2036," said Mr. Myron Holubiak, President and CEO of Citius Pharmaceuticals. "The stability of the Mino-Lok solution post mixing was limited to a time period of about 24 hours prior to use. Through the good work of technologists at MDACC, we now are producing a product that maintains stability for 3 full days post-mixing. This will make it easier for Mino-Lok to be prepared under standard pharmacy procedures and would allow for several days storage of ready-to-use Mino-Lok. Aside from also offering greater intellectual property protection, the post-mix stability of Mino-Lok is important to the potential world market for the product."

Mino-Lok is currently being studied in phase 3 in over a dozen medical centers in the United States. There are currently no approved therapies to salvage infected CVCs. 

Catheter Related Bloodstream Infections ("CRBSIs") are some of the most difficult infections to treat, and, are a leading cause of healthcare-associated infections (HAIs) with substantial morbidity and mortality. Patients with CRBSI may be at risk for serious complications, including septic thrombosis, endocarditis, and disseminated infection. Many of these patients need to have their central venous catheters removed and subsequently replaced, causing added costs, morbidities and discomfort. Removal and reinsertion of a new CVC may be difficult or even impossible due to the unavailability of other accessible vascular sites. Furthermore, critically ill patients often have underlying coagulopathy, which may increase the risk of mechanical complications (e.g., hemopneumothorax, misplacement, or arterial puncture with severe hematomas and attendant blood loss) with the reinsertion of a new catheter at a different site.

Mino-Lok® is under investigation and not approved for commercial use.

About Citius Pharmaceuticals, Inc.Citius is a specialty pharmaceutical company dedicated to the development and commercialization of critical care products, with a focus on anti-infectives, cancer care and unique prescription products that use innovative, patented or proprietary formulations of previously-approved active pharmaceutical ingredients. We seek to achieve leading market positions by providing therapeutic products that address unmet medical needs; by using previously approved drugs with substantial safety and efficacy data, we seek to reduce the risks associated with pharmaceutical product development and regulatory requirements. Citius develops products that have intellectual property protection and competitive advantages to existing therapeutic approaches. For more information, please visit www.citiuspharma.com.