Hemispherx Biopharma and UNMC Partner to Take on Pancreatic Cancer

Source:  Hemispherx Biopharma, Inc.

Study Combines Ampligen Drug, Peptide Vaccine in Attempt to Enhance Immune System

The University of Nebraska Medical Center and Hemispherx Biopharma, Inc. (NYSE American:HEB) are joining forces to take on pancreatic cancer, one of the most deadly forms of cancer. In mouse model studies, Hemispherx’s immune-enhancing drug, Ampligen – an immune-enhancer TLR3 agonist – will be administered with a peptide vaccine developed by UNMC.

The study will test the capability of Ampligen to enhance immune responses when combined with a peptide vaccine developed by UNMC for MUC1-positive pancreatic cancer. MUC1, a tumor-associated antigen, is produced by many common, highly lethal cancers, including cancers of the colon, breast, ovary, lung and pancreas.

In the study, UNMC researchers will immunize mice with pancreatic tumors expressing MUC1. The mice will receive Ampligen in combination with the peptide vaccine, with subsequent immune checkpoint blockade. 

“A prior preclinical vaccine study at UNMC using Ampligen in combination with the checkpoint blockade yielded promising results,” said David Strayer, MD, chief scientific officer for Hemispherx. “The objective now is to expand this experimental vaccination approach using Ampligen and a more specific antigen in combination with the checkpoint blockade. We believe these studies may yield important insights.”

UNMC is one of the leading institutions in the country in studying pancreatic cancer. In 2014, UNMC received a five-year renewal of its $11.5 million pancreatic cancer SPORE (Specialized Programs of Research Excellence) grant from the National Cancer Institute.

“We are working hard to discover better treatments for pancreatic cancer,” said Tony Hollingsworth, Ph.D., the Leon Professor of Cancer and director of pancreatic cancer research for UNMC. “We believe Ampligen is an agent that holds tremendous promise – not only for pancreatic cancer, but also for a variety of other cancers.”

“We are delighted UNMC is continuing with these animal studies as part of our step-by-step progression to develop effective treatments that will prolong or possibly save the lives of people with pancreatic cancer, a devastating disease with a five to six percent five-year survival rate,” said Thomas K. Equels, chief executive officer of Hemispherx. “Finding a cure for this highly lethal malignancy 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 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.
About University of Nebraska Medical Center
University of Nebraska Medical Center’s mission is to lead the world in transforming lives to create a healthy future for all individuals and communities through premier educational programs, innovative research and extraordinary patient care.

 

Hemispherx To Supply Ampligen for Pancreatic Cancer Patients in Canada Under Special Access Program

Source:  Hemispherx Biopharma, Inc.

Agreement with myTomorrows, Following Success in Netherlands, Seeks to Expand Ampligen Early Access Programs in Pancreatic Cancer into Canada

Hemispherx Biopharma, Inc. (NYSE American:HEB) said it is expanding its partnership with myTomorrows to supply Ampligen® for pancreatic cancer patients in Canada under a Special Access Program (SAP).

Amsterdam-based myTomorrows, an international leader in providing physicians access to experimental medicines, is conducting a similar program with Ampligen in Europe, where it is called an EAP, or Early Access Program.

In clinical trials in a variety of indications, approximately 100,000 doses of the experimental drug Ampligen have been administered, IV or intranasally, resulting in one of the most comprehensive safety profiles of a Toll-like receptor agonist. Toll-like receptors (TLRs) are a class of proteins that play a key role in activating the innate immune system.

As a selective activator of the TLR3 pathway, Ampligen stimulates important components of the immune system. It has been tested as a vaccine adjuvant, and it is in late-stage development for ME/CFS. In recent cancer studies, combinational use of Ampligen has been shown to make certain cancers more responsive to immuno-oncology agents such as checkpoint inhibitors.

The program is expected to be in place as of May 2018. Physicians who participate in the program will use their clinical judgment in choosing whether to use Ampligen as a stand-alone immuno-therapy agent or in combination with other drugs or with surgery.

Thomas K. Equels, CEO of Hemispherx, noted that the growing popularity of checkpoint blockade therapy has broadened the potential of Ampligen in immuno-oncology beyond single-agent use, with new data helping to define its potential role as a combinational agent in promoting killer T cell accumulation in the tumor microenvironment.

“Data presented last month by Dr. Pawel Kalinski of the Roswell Park Cancer Institute at the Immuno-Oncology Frontiers Conference showed that combination Ampligen had a positive modulating effect on the PD-1/PD-L1/PD-L2 system in human ovarian and colorectal cancers. Pancreatic cancer is an extremely lethal malignancy with a 95% mortality rate. Therefore, this unmet medical need is a top priority for team Hemispherx,” Mr. Equels said. 

Physicians or individuals living in Canada who are interested in learning more about Ampligen should contact myTomorrows at medical@mytomorrows.com

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.

 

Hemispherx’s Ampligen Highlighted in Review of Role of TLR3 Agonist Support for “Universal” Flu Immunization Development Programs

Source:  Hemispherx Biopharma, Inc.

Three Studies Reviewed at Keystone Symposium on Emerging Technologies in Vaccine Discovery and Development Demonstrate Production of Antibodies Against Highly Pathogenic Strains of Avian Flu Viruses with Human Pandemic Potential with Seasonal Vaccines

Hemispherx Biopharma, Inc. (NYSE American:HEB) said William Mitchell, MD, PhD*, Professor of Pathology, Microbiology & Immunology at Vanderbilt University, provided the first composite review of previously published studies of the potential role of Ampligen® (rintatolimod) in creating broader viral coverage of seasonal vaccines. 

The first of the studies was in rodents, next in non-human primates (monkeys), and the third in healthy human subjects.  The impetus for the three peer-reviewed research programs originated with Hideki Hasegawa, MD, PhD, Director Department of Pathology at Japan’s National Institute of Infectious Diseases, which sponsored the rodent and monkey studies. Commenting recently, Dr. Hasegawa said in response to this review, “Our experimental findings in rodents and non-human primates using intranasal vaccination clearly showed that Ampligen enhanced the activity of influenza vaccines by conferring increased cross-reactivity and cross-protection, even with deadly avian H5N1 influenza viruses.  Such effects will be key to the development of a universal vaccine for influenza.”

William Mitchell, MD, PhD, Professor of Pathology, 

Microbiology & Immunology at Vanderbilt University

Hemispherx Biopharma, Inc.

The positive rodent and monkey findings led to a human study at the University of Alabama, sponsored by Hemispherx. The Principal Investigator of this Phase 1/2 trial of 12 healthy volunteers was Edgar Turner Overton, MD. Dr. Overton stated regarding this review,  “Building on the work of Dr. Hasegawa, we studied intranasal Ampligen administration following influenza vaccine clinically.  The Ampligen was well-tolerated and evidence for cross-reactivity against avian influenza strains was also seen in humans.” The study found that the combination of intranasal FluMist® followed by intranasal Ampligen produced specific secretory IgA antibody responses of at least 4-fold over baseline against at least one of the homologous vaccine strains in the vaccine in 92 percent of the subjects.  Moreover, the experimental vaccination strategy induced cross-reactive secretory IgA antibodies against highly pathogenic avian influenza strains H5N1, H7N9, and H7N3, all with pandemic potential for humans. The researchers reported that the combination of Ampligen and FluMist was well-tolerated. 

Professor Mitchell from Banff stated, “The current poor protection afforded by this season’s flu vaccines, ~10% in Australia and ~30% in North America, provides greater incentive for a ‘universal’ vaccine providing high protection for multiple years against the yearly minor changes referred to as antigenic drift as well as major changes from influenza viruses prevalent in animal reservoirs that have acquired easy infectivity in humans (antigenic shift).The data from the Japanese National Institute of Infectious Diseases and the University of Alabama reviewed today clearly demonstrate that the elements of a universal vaccine may be achievable through simply administered nasal immunization of seasonal vaccines in combination with a TLR3 agonist (Ampligen/ rintatolimod) to achieve immune enhancement by ‘epitope spreading’. The data demonstrated in animals and humans show the generation of antibodies against highly pathogenic avian influenza viruses with high lethality in humans, ~60% for H5N1 and ~40% for H7N9, with super pandemic potential if the ability to easily infect humans through antigenic shift is obtained with retention of high lethality. Data from the Banff meeting suggest technical pathways to achieve maximum responses for the original observations reported by Dr. Hasegawa.”

David R. Strayer, MD, chief scientific and medical officer of Hemispherx, noted that, “proven technology exists to create and make vaccines to protect against the specific strain of flu virus predicted to be the most prevalent for the coming season.  However, the source of seasonal vaccine ineffectiveness rests in the lengthy manufacturing lead time and the potential of the selected strain to mutate, rendering the vaccine less effective or not effective at all. The quest is for a ‘universal’ vaccine that can protect against all major known classes of the virus, a goal which may be achieved only by introducing, through an agent like Ampligen, elements of cross reactivity and cross protection.  After decades of research to develop a safe and effective universal flu vaccine, the goal is still unfulfilled. Ampligen may with additional testing be a relatively quick way to provide a safe and effective approach against the debilitating, costly and frequently lethal influenza viruses.”

*Dr. William Mitchell also serves as the independent chairman of the board of Hemispherx.

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.

 

Hemispherx Comments on $500+ Million Market Opportunity for Ampligen®, the Only Late Stage ME/CFS Candidate in the U.S.

Source:  Hemispherx Biopharma, Inc.

Ampligen® has orphan drug status in the U.S. for treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Hemispherx Biopharma, Inc. (NYSE American:HEB), focused on pharmaceutical research, today commented on the overall market opportunity for its Ampligen^® drug candidate in treating Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS),  given the recent announcement by clinicians regarding the failure of Rituximab ME/CFS trial in Europe. See Link: http://simmaronresearch.com/2017/11/norwegian-rituximab-chronic-fatigue-syndrome-mecfs-trial-fails/ ME/CFS is a serious, debilitating condition that imposes a burden of illness on millions of people in the U.S. and around the world, leaving hundreds of thousands seriously disabled worldwide.

ME/CFS can cause significant impairment and disabilities that have negative economic consequences at both the individual and the societal level. At least one-quarter of ME/CFS patients are house- or bed-bound at some point in their lives (Marshall et al., 2011; NIH, 2011; Shepherd and Chaudhuri, 2001). The direct and indirect economic costs of ME/CFS to society have been estimated at $17 to $24 billion annually (Jason et al., 2008), $9.1 billion of which has been attributed to lost household and labor force productivity (Reynolds et al., 2004). High medical costs combined with reduced earning capacity often have devastating effects on patients’ financial status and their family life.

In the U.S., there are no approved treatments for ME/CFS. Ampligen^®, which enjoys orphan drug status for ME/CFS, is the only drug in late-stage clinical development. The company has completed CFS Phase I/II/III studies in the U.S. for Ampligen^®, which has demonstrated clinically significant improvements in patient exercise performance in two randomized, placebo-controlled pivotal trials and the FDA is requiring a confirmatory trial. Ampligen^® is already approved in Argentina, where it is the first and only drug ever approved anywhere in the world as a therapy for ME/CFS.

The Company is focusing its NDA and confirmatory trials in the U.S. for severely debilitated ME/CFS patients on a target population of approximately ~100,000. The company estimates that a market penetration of only 10 percent would result in peak annual sales of over $500 million¹. Hemispherx is in the final stages of producing commercial lots with some of its recently acquired funding, which are needed to launch Ampligen^® in Argentina. Increasing Ampligen production is also essential for upcoming clinical activities in both ME/CFS and oncology to move forward in the U.S, Europe and Canada.  

Dr. Daniel Peterson, a world renowned independent expert in the treatment of ME/CFS and in the clinical use of Ampligen^® (or rintatolimod), states that it “… is a potentially useful drug for a subset of severely ill ME/CFS patients to improve quality of life and functional status. Based on extensive clinical experience and testing, rintatolimod has an excellent safety profile. In addition, there are clear outcome measures that can be used to assess the drug’s efficacy in planned confirmatory trials.”

“We are optimistic about the prospects for Ampligen^® and its potential to help tens of thousands of people who currently have no treatment options. Our company is focused on getting Ampligen^® to the final stage for regulatory approval for ME/CFS in the U.S. and preparing for an ME/CFS commercial launch in Argentina,” said Thomas K. Equels, chief executive officer of the company. Mr. Equels recently wrote an address to Hemispherx’s Stockholders and Employees about the importance of seeking an approved therapy for ME/CFS. The Stockholder/Employee Address can be found at (http://ir.hemispherx.net/Events_Presentations).

¹Assuming an average of two vials per dose twice a week over 48 weeks.

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.

 

Hemispherx Enters into Sale/Leaseback Agreement for NJ Development and Production Facility

Source:  Hemispherx Biopharma, Inc.

Transaction helps boost Ampligen production to maximum levels

Hemispherx Biopharma, Inc. (NYSE American:HEB), focused on pharmaceutical research, today said it has entered into a sale and leaseback agreement for the property it owns at 783 Jersey Lane, New Brunswick, NJ., which houses the company’s development and production facilities.

Under the terms of the agreement, Hemispherx is selling the real estate for $4.0 million, and simultaneously entering into a 10-year lease with options to extend the lease for another 10-years. The company will retain the right to repurchase the property at any time during the initial lease. The facility’s lease payments under the agreement are offset by about 50% by the contemporaneous termination of the very expensive lease on its Philadelphia offices. The combination of these transactions raises cash for operations with only a modest increase in the burn rate.

“This is a timely transaction for Hemispherx on favorable terms. It allows us to increase our production capabilities for Ampligen® to meet existing demands and projected higher requirements during the balance of this year and beyond,” said Thomas K. Equels, Chief Executive Officer of the Company. 

Hemispherx is in the final stages of producing commercial lots which are needed to launch Ampligen® in Argentina, where it is the first and only drug ever approved anywhere in the world as a therapy for Myalgic Encephalomyelitis, commonly known as Chronic Fatigue Syndrome or ME/CFS. Increased production is important to allow clinical activities in both ME/CFS and oncology to move forward in the U.S. Furthermore, Ampligen production is key to Early Access Programs in Europe and planned programs in Canada.

“Hemispherx commitment to success is unwavering and converting wholly owned real estate into cash for operations and drug production without a dramatic increase in the burn rate is just a part of our overall financial plan,” states Equels, “We must remember that Ampligen stands as a potentially powerful mediator for dire unmet medical needs. We cannot serve those in need if we do not take the important financial steps necessary to manufacture Ampligen in sufficient quantities to allow it to gain regulatory approvals in major markets.”

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.

 

Hemispherx Enhances Manufacturing Efficiency of Ampligen

Source: Hemispherx Biopharma, Inc.

New Technology Simplifies, Speeds Production of Immuno-Oncology Candidate

Hemispherx Biopharma, Inc. (NYSE American:HEB), has successfully tested a new chemical catalyst used in the manufacturing process of Ampligen®, a novel molecule currently being tested in combination therapy to potentially enhance the performance of checkpoint inhibitors, one of the fastest growing classes of immuno-oncology agents. 

Carol Smith, PhD, chief manufacturing officer, said “This development has a number of tangible benefits in terms of improved manufacturing efficiency and assured availability of a key manufacturing material. The new development can provide a consistent enzyme product, uninterrupted production of Ampligen®, and, in the long run, reduce production costs.”
The manufacture of Ampligen®, a double-stranded RNA, requires an enzyme which historically has been difficult to prepare. Recently, the gene coding for this enzyme was cloned and the production of the expressed enzyme is currently being scaled up for use in the manufacture of both RNA strands that are combined to form the Ampligen® molecule.

Hemispherx said that, during the scale up of the cloned enzyme, it has the equivalent of 18,000 vials of base product now ready for compound, fill and finish for projected distribution this year with an estimated value of $10.3 million.  Development of the new enzyme process is planned to facilitate production of the Ampligen® RNA strands for future needs.

Earlier this week, Hemispherx announced that a presentation will be made by Pawel Kalinski, MD, PhD, Rustum Family Professor for Molecular Therapeutic and Translational Research at Roswell Park Cancer Institute in Buffalo, NY on January 24 at the Immuno-Oncology Frontiers Conference in Miami, FL. detailing evidence of a favorable immuno-modulatory activity of Ampligen® on the tumor microenvironment, which may help convert cold tumors that are unresponsive to immunotherapy to tumors that will respond to immunotherapeutic drugs such as checkpoint inhibitors. 

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.

 

Hemispherx Successfully Completes Commercial Scale Demonstration Batch of Ampligen® at Contract Manufacturer

Source:  Hemispherz Biopharma, Inc.

Hemispherx Biopharma (NYSE American:HEB) said, its Contract Manufacturing Organization (CMO) for Ampligen® has  completed a commercial scale demonstration/engineering manufacturing run,  along with the re-qualifications of analytical methods that were agreed upon during a previous successful Pre-Approval Inspection (PAI) as necessary prior to the production of commercial lots of Ampligen®.

This accomplishment, in addition to completing all qualification operations to address new equipment and new container closure/vial components, allows the manufacture of current Good Manufacturing Practice (cGMP) clinical product in March 2018 following a scheduled shut down of the CMO for its bi-annual maintenance program.  Completion of the demonstration/engineering manufacturing run provides confidence that the clinical product will meet the stringent quality control release and stability testing prior to release and should be available to patients by the end of the second quarter 2018.  The manufacture of a second clinical lot of Ampligen® is being scheduled to assure maintenance of the clinical supply inventory.

• Ampligen® has been approved in Argentina for severely debilitated Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) patients. Hemispherx recently reported that discussions are underway with the U.S. FDA on the next steps regarding a New Drug Application (NDA) for Ampligen® in ME/CFS, which afflicts more than one million people in this country, according to the Centers for Disease Control (CDC). Ampligen® is the only drug to have completed a Phase 3 clinical trial in the U.S. in ME/CFS.
   
• Earlier this year Hemispherx began supplying Ampligen® for pancreatic cancer patients in an Early Access Program (EAP) in the Netherlands.  In addition, work is underway at two leading U.S. cancer centers to define Ampligen®’s potential role in enhancing the effectiveness of PD-1 and PD-L1 checkpoint inhibitors in the fast-growing field of immuno-oncology. 

Commenting on the importance of this event, Hemispherx Biopharma’s CEO, Thomas Equels states, “We are pleased to announce the achievement of this important milestone in our plan to manufacture Ampligen® in large volume lots for the purpose of supplying drug for our upcoming clinical programs as well as for manufacture and sale internationally.”

About Hemispherx Biopharma, Inc.
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.

Hemispherx Highlights Year-To-Date Progress, Outlines Key Objectives

Source:  Hemispherx Biopharma, Inc.

Letter to Shareholders Posted on Website

Revenue Up, Burn Rate Down Dramatically; Progress Cited with FDA Discussions on Ampligen; Manufacturing Facility for FDA-Approved Alferon N Fully Repaired; Immuno-oncology Seen as Major Opportunity

Hemispherx Biopharma (NYSE American:HEB) announced the posting of a letter to shareholders on its website, www.hemispherx.com, in which CEO Thomas K. Equels reviews corporate activities progress over the past nine months and outlines key objectives going forward.
The letter appears below:

To our shareholders:

We have achieved significant milestones during the short period of time I have been CEO. We are making steady progress with our plans to commercialize Alferon N Injection®, expand the market opportunities for Ampligen®, and streamline operating infrastructure and related costs to put us on a stronger financial footing.

Drastically reduced our cash burn rate while aggressively opening new opportunities for Ampligen in the fast-growing field of immuno-oncology

Specifically, revenue for the first nine months of 2017 totaled $387,000, a greater than five-fold increase compared to $76,000 a year ago, and our net loss for the quarter ended September 30, 2017 decreased by more than 50 percent to $1.3 million from $2.9 million a year-ago. The more than fifty-percent decrease is attributed to a reduction of operating expenses of $0.5 million and an increase in revenue of $1.4 million resulting from the revaluation of the redeemable warrants as of September 30, 2017.  Operating costs and expenses, inclusive of research and development, were $2.7 million in the quarter just ended vs. $3.2 million in the year-ago period. The bottom line is we have achieved important milestones and reduced expenses as compared to prior years.

Moreover, we have tremendous confidence in our product portfolio. I believe Ampligen is the ‘shape of things to come’ in immunology. It is poised to potentially become an important therapy in the rapidly expanding field of immuno-oncology. It is the only activator of Toll-like Receptor 3 with a well-established safety record.

Some of the key developments in our Ampligen program have included regulatory approval in one of South America’s largest markets, a stepped-up collaboration to support a regulatory submission for ME/CFS in Canada, positive results from an intranasal safety study, and several new initiatives to leverage the immunotherapeutic properties of Ampligen in state-of-the-art cancer treatment strategies. 

Key Advancements For Ampligen

• Ampligen has been approved in Argentina for severely debilitated Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) patients and we are pursuing similar approvals in Chile and Peru. We are collaborating with Millions Missing Canada to bring Ampligen to Canadians suffering from ME/CFS. In addition, we are in continuing discussions with the FDA regarding our New Drug Application in ME/CFS. Ampligen is the only drug to have completed a Phase 3 clinical trial in the U.S. in ME/CFS, a condition which according to the Center for Disease Control (CDC) afflicts more than one million people in this country.  Taking into account that trial’s results, and the FDA’s indication at our last meeting that they would be open and receptive to review a proposal by the Sponsor (Hemispherx), we plan to seek approval tied to a protocol we are developing for conducting a study, limiting enrollment to patients with high responder potential.
  
  
• Earlier this year we began supplying Ampligen for pancreatic cancer patients in an Early Access Program (EAP) in the Netherlands managed by myTomorrows, an international leader in providing physicians with early access to experimental drugs.
  
  
• Significant research at the University of Pittsburgh and Roswell Park Cancer Center is underway to determine the extent to which Ampligen alone and in combination with other agents may prime the tumor microenvironment in ways that could improve the lethality of cancer-killing T cells in conjunction with PD-1 and PD-L1 checkpoint inhibitors, such as Keytruda from Merck and Opdivo from Bristol-Myers Squibb. The success of these studies and others being planned could lead to a significant advance in the fast-growing field of immuno-oncology.
  
• Attracting a greater number of antigen-specific cytotoxic T cells into the tumor microenvironment while increasing their ratio to immunosuppressive Treg cells is expected to significantly improve the overall effectiveness of checkpoint inhibitors, a new class of drugs designed to destroy the blocking mechanisms that prevent effector cytotoxic T cells from attacking tumor cells. The use of checkpoint inhibitors is growing rapidly (Cowan & Co. projects sales to grow to $30 billion annually by 2020) and we are developing Ampligen with the anticipation of it becoming an integral part of combinational therapies tapping into that growth.
  
• We recently commenced full data analysis of an intranasal vaccine study of Ampligen plus FluMist.  Intranasal Ampligen was generally well-tolerated in this study. Numerous studies have shown that Ampligen is a generally well-tolerated and highly selective Toll-like Receptor 3 agonist capable of inducing the innate immune responses needed for adaptive protective immunity. Monkeys immunized with H5N1 vaccine and Ampligen showed enhanced protection against a highly pathogenic H5N1 virus. Mouse models showed Ampligen generates cross-protection against 3 clades of highly pathogenic H5N1 using a seasonal vaccine. The human intranasal safety study demonstrated antibodies against viral strains not present in the immunizing vaccine. Highly pathogenic bird strains of influenza remain a clear and present human danger for a devastating influenza pandemic. Only one or two mutations in the viral attachment receptor of these highly pathogenic bird influenza viruses are required to provide an easily spread and highly lethal virus in humans. The clinical data from our FluMist study extends the mouse and monkey studies. The experimental data suggests that intranasal immunization with Ampligen may provide a rapid and well tolerated means of protection in at-risk humans. We are currently exploring co-development partnerships with vaccine producers. 

Our cancer-directed programs with Ampligen build on a safety data base consisting of approximately 100,000 Ampligen doses, primarily in ME/CFS trials, and earlier Phase 1/2 oncology clinical studies including renal cell carcinoma and metastatic melanoma.

We have finalized a commercial-scale “fill and finish” production agreement to fulfill our forecasts for Ampligen demand in 2018. New inventory is planned to be available 2Q18 for Argentina, for US based clinical studies and for Early Access Program sales in Europe.

New Jersey manufacturing facility - completed work to resume production and awaiting funding and FDA re-certification

It will cost about $10 million to put the Alferon manufacturing line at the New Brunswick, NJ plant back into full operation. We are exploring several avenues for funding. While the insurance has fully covered the physical damage to the plant, we are still working to get additional coverage under policy provisions which will help us defray the costs of restarting production. In the interim we are also examining other options, including co-development opportunities.As many of you know, we experienced a major setback in our Alferon N Injection program when a broken water main for the sprinkler system flooded key sections of our New Jersey manufacturing facility. Insurance has reimbursed us for all the physical damage and all repair and reconstruction work has been completed. The next step is FDA re-certification of the facility.

We have an agreement with Asembia, a leading national supplier to specialty pharmacies, to market and distribute the product in the U.S. when manufacturing resumes.  Alferon N is approved for refractory or recurring external genital warts in the US and Argentina, and is also approved in Argentina for any patient refractory to recombinant interferon.

In summary, the stage is set for Hemispherx to capitalize on significant new opportunities during the balance of this year and 2018. We have repaired our flood-damaged manufacturing facility.  It is now ready, pending additional start-up funding and FDA certification, to produce FDA-approved Alferon N Injection. A marketing and distribution agreement is in place. We have secured our first country approval for Ampligen in ME/CFS and we expect several more in the coming years. We are steadily expanding our EAP strategy for Ampligen internationally.  We are making progress in defining the next steps for FDA registration of Ampligen. We are aggressively opening new opportunities for Ampligen in the fast-growing field of immuno-oncology.  All of this is being accomplished with cautious use of capital and our commitment to increasing shareholder value. Our new management motto is EFFICIENT EXECUTION OF PRIORITY GOALS. We have accomplished all the above while slashing the burn rate by 50 percent.

I look forward to keeping you updated on our progress.

/s/Thomas K. Equels

Chief Executive Officer

About Hemispherx Biopharma, Inc.
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.

BioSig Technologies to Partner with Focus Marketing

Source:  BioSig Technologies, Inc.

Experienced Electrophysiology Marketing Leaders to Assist with Commercial Launch

BioSig Technologies, Inc. (OTCQB: BSGM), a medical device company developing a proprietary biomedical signal processing platform designed to address an unmet technology need for the $4.6 billion electrophysiology (EP) marketplace, today announced that the Company appointed Focus Marketing to assist BioSig’s commercial team in preparation for the targeted launch of its PURE EP™ System. 

California based Focus Marketing is a boutique consulting firm with deep experience in electrophysiology.  Led by two former Biosense Webster marketers, the company delivers both strategic marketing guidance and tactical execution support for the healthcare and technology sectors.

Mrs. Cortney Donaldson, the company’s Founder and Principal Consultant, brings over 15 years of marketing and sales experience, having worked with a number of Fortune 50 companies on the development of new product plans and sales support execution. Prior to starting Focus Marketing, Mrs. Donaldson held a number of leadership roles, including Group Product Director at Biosense Webster, in which she was responsible for strategic company partnerships as well as the ultrasound and diagnostic product lines.

Ms. Carolyne MacLellan, the company’s Strategic Marketing Consultant, has extensive experience in clinical, sales and marketing roles at Biosense Webster, working directly with the key opinion leaders within the cardiac electrophysiology field. A cardiovascular technologist by training, she has successfully developed and launched a number of electrophysiology projects, including a global brand refresh for the CARTO^® 3 system and CONFIDENSE™ and CARTOREPLAY™ modules in the U.S. market.   

“The Focus Marketing Team has extensive history of successfully introducing technology in the EP space and we are excited about our new partnership with BioSig Technologies. The PURE EP™ System can bring a new level of signal clarity to electrophysiologists and has the potential to influence the treatment of AF and VT in meaningful ways,” commented Ms. MacLellan and Mrs. Donaldson.

“High quality marketing strategy and support is essential for a commercial launch. Cortney and Carolyne have impressed us with their remarkable track record in building clinical relations, commercialization, and their knowledge of electrophysiology. We are pleased to welcome them, and we are confident that our shareholders will benefit from their capabilities,” commented Kenneth L. Londoner, Chairman and CEO of BioSig Technologies, Inc.

About BioSig Technologies
BioSig Technologies is a medical device company developing a proprietary biomedical signal processing technology designed to improve the $4.6 billion electrophysiology (EP) marketplace (www.biosigtech.com). Led by a proven management team and a veteran, independent Board of Directors, Los Angeles-based BioSig Technologies is preparing to commercialize its PURE EP™ System. The technology has been developed to address an unmet need in a large and growing market.

The Company’s first product, PURE EP™ System, is a novel cardiac signal acquisition and display system which is engineered to assist electrophysiologists in clinical decision making during procedures to diagnose and treat patients with abnormal heart rates and rhythms. BioSig’s main goal is to deliver technology to improve upon catheter ablation treatments for the prevalent and deadly arrhythmias, Atrial Fibrillation and Ventricular Tachycardia. BioSig has partnered with Minnetronix on technology development and is working toward FDA 510(k) clearance for the PURE EP™ System.

BioSig Technologies to Open Operations Center in Austin, Texas

 

Source:  BioSig Technologies, Inc.

 

New Location to Support Company Growth and Commercialization

BioSig Technologies, Inc. (OTCQB: BSGM), a medical device company developing a proprietary biomedical signal processing platform designed to address an unmet technology need for the $4.6 billion electrophysiology (EP) marketplace, today announced that the Company is opening a new office in Austin, Texas. 

The new offices will complement the Company’s headquarters in Los Angeles, CA and will become an operational hub hosting administration, field engineering and sales.

Texas is the second largest economy in the US and accounts for $1.6 trillion of the country’s GDP(1), making the state the 10th largest economy in the world. Attractive business climate, historically low tax rates and abundance of natural resources has allowed the state to become home to six of the top 50 companies on the Fortune 500 list(2). Steady economic growth has also led to the development of Texas’ healthcare industry. The state is home to some of the largest and most advanced medical centers in the US and the world.

“Texas has always been one of the key locations for BioSig, both for clinical development and capital formation. As we advance towards commercialization, we want to build a permanent hub in one of the most strategic locations for commercial launch and clinical activities. We are confident that having a strong operational office in Austin will allow us to grow our Company, support development activities and drive shareholder value,” commented Kenneth L. Londoner, Chairman and CEO of BioSig Technologies, Inc.

About BioSig Technologies
BioSig Technologies is a medical device company developing a proprietary biomedical signal processing technology designed to improve the $4.6 billion electrophysiology (EP) marketplace (www.biosigtech.com). Led by a proven management team and a veteran, independent Board of Directors, Los Angeles-based BioSig Technologies is preparing to commercialize its PURE EP(TM) System.  The technology has been developed to address an unmet need in a large and growing market.

The Company’s first product, PURE EP(TM) System, is a novel cardiac signal acquisition and display system which is engineered to assist electrophysiologists in clinical decision making during procedures to diagnose and treat patients with abnormal heart rates and rhythms. BioSig’s main goal is to deliver technology to improve upon catheter ablation treatments for the prevalent and deadly arrhythmias, Atrial Fibrillation and Ventricular Tachycardia. BioSig has partnered with Minnetronix on technology development and is working toward FDA 510(k) clearance for the PURE EP System.

Citius Reports Progress in Hemorroid Treatment Program

Source:  Citius Pharmaceuticals, Inc.

- Selection of Higher Potency Corticosteroid For Phase 2b Trial to Improve Efficacy and Faster Onset of Symptomatic Relief

- Target Population to include Patients with Grade 2 and 3 Hemorrhoids

- Revised Program Discussed with the FDA

Citius Pharmaceuticals, Inc. ("CITIUS") ("Company") (NASDAQ: CTXR), a specialty pharmaceutical company, announced that the Company is selecting a higher potency corticosteroid in its steroid/anesthetic topical formulation program for the treatment of hemorrhoids. The original topical preparation, CITI-001, was a combination of hydrocortisone acetate and lidocaine hydrochloride. The new formulation, CITI-002, will combine lidocaine with the higher potency corticosteroid for symptomatic relief of the pain and discomfort of hemorrhoids. While not used in combination in currently marketed products, the proposed corticosteroid is included as an FDA-approved topical product to treat a variety of dermatological disorders.

The Company held a Type C meeting with the FDA to discuss the results of the Phase 2a study and to obtain the Agency's view on development plans to support the potential formulation change for the planned Phase 2b study. Citius also requested the Agency's feedback on the Phase 2b study design, including target patient population, inclusion/exclusion criteria, and efficacy endpoints. The pre-clinical and clinical development programs for CITI-002 are planned to be similar to those conducted for the development of CITI-001 to support the design for a planned Phase 3 clinical trial. 

Myron Holubiak, CEO of Citius, said, "We made this decision to take advantage of the efficacy exhibited with higher potency steroids in reducing inflammation and in the faster onset of relief for hemorrhoid patients. In our planned Phase 2b trial, we will focus our attention on more severe hemorrhoidal disease, Grade 2 and 3, where a prescription strength may be more urgently needed.  We will also be using the proprietary formulation we have developed since completing our CITI-001 clinical trial."

Hemorrhoids are a common gastrointestinal disorder characterized by pain, swelling, itching, tenderness, and bleeding. Hemorrhoids affect nearly 5% of the U.S. population, with 10 million patients reporting symptoms and a third seeking treatment from doctors. Between 50% and 90% of the population will experience hemorrhoid disease in their lifetime. The potential prescription market in the U.S. is very large with over 25 million units of topical products for hemorrhoids being sold annually in the U.S."

Currently, there are no approved prescription products, alone or in combination, for the treatment of hemorrhoids. Citius plans to use the FDA's 505(b)(2) pathway for new drug approvals.

CITI-002 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 using 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. We focus on developing products that have intellectual property protection and competitive advantages to existing therapeutic approaches. www.citiuspharma.com

Citius Announces Enrollment Of First Patient In The Mino-Lok™ Phase 3 Trial

Source:  Citius Pharmaceuticals, Inc.

PIVOTAL TRIAL TO ASSESS EFFECTIVENESS AND SAFETY OF MINO-LOK™ IN THE TREATMENT OF INDIVIDUALS WITH CATHETER RELATED BLOOD STREAM INFECTIONS 

Citius Pharmaceuticals, Inc. ("Citius") ("Company") (NASDAQ: CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, announced that yesterday the first patient was randomized into the Mino-Lok Phase 3 clinical trial for catheter related bacteremias ("CRBSIs") at the Henry Ford Health System in Detroit, Michigan. When fully-recruited, it is planned that there will be 700 patients enrolled in 50 participating institutions, throughout the U.S.

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 ("CVCs") 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, such as hemopneumothorax, misplacement, or arterial puncture, with the reinsertion of a new CVC at different site.

"We are pleased to enroll the first patient in the Mino-Lok™ phase 3 trial, which is designed to further our understanding of the efficacy of antibiotic lock solutions in salvaging infected catheters in the treatment of this serious infection," stated Mr. Myron Holubiak, President and CEO of Citius.  "We believe we are at the forefront of providing much needed evidence that antibiotic lock therapy is an attractive alternative to removing and replacing infected central lines.  This will be the largest and most definitive study of its kind conducted to date.

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 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.

Mr. Holubiak continued, "Because of the unique properties of Mino-Lok, we believe we will be able to show that our proprietary 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, especially M.D. Anderson Cancer Center, for their help in bringing Mino-Lok to this juncture."

Mino-Lok^TM 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 aims to develop products that have intellectual property protection and competitive advantages to existing therapeutic approaches. For more information, please visit www.citiuspharma.com.

About MD Anderson Cancer CenterThe University of Texas MD Anderson Cancer Center in Houston ranks as one of the world's most respected facilities for cancer patient care, research, education and prevention. The institution's sole mission is to end cancer for patients and their families around the world. MD Anderson is one of only 45 comprehensive cancer centers designated by the National Cancer Institute (NCI) and is ranked No.1 for cancer care in U.S. News & World Report's most recent "Best Hospital's" survey. The center has ranked as one of the nation's top two hospitals since the survey began in 1990, and has ranked first for 11 of the past 14 years. MD Anderson receives a cancer center support grant from the NCI of the National Institutes of Health (P30 CA016672).

About the Henry Ford Health System Henry Ford Health System is committed to improving the health and well-being of a diverse Michigan community. Founded in 1915 by auto pioneer Henry Ford and now one of the nation's leading health care providers, Henry Ford Health System is a not-for-profit corporation governed by a 17-member Board of Trustees, with volunteer-led advisory and affiliate boards providing additional leadership. It is comprised of hospitals, medical centers and one of the nation's largest group practices, the Henry Ford Medical Group, which includes more than 1,200 physicians practicing in over 40 specialties. The System's flagship, Henry Ford Hospital in Detroit, is a Level 1 Trauma Center recognized for clinical excellence in cardiology, cardiovascular surgery, neurology and neurosurgery, orthopedics, sports medicine, multi-organ transplants and cancer treatment. The Henry Ford Health System provides care to 3.3 million patient visits annually. With more than 30,000 employees, Henry Ford Health System is the fifth-largest employer in metro Detroit, and among the most diverse. Henry Ford Health System was one of only four 2011 recipients of the Malcolm Baldridge National Quality Award and the only organization in Michigan to receive it.

Citius Publishes Expert Roundtable Discussion On Treatment Considerations For Catheter Related Bacteremias

Source:  Citius Pharmaceuticals, Inc.

SALVAGING INDWELLING CATHETERS IS ESSENTIAL WHEN THERE IS NO VASCULAR ACCESS AND THE PATIENT NEEDS LONG TERM CHRONIC PARENTERAL THERAPY

 Citius Pharmaceuticals, Inc. ("Citius") ("Company") (NASDAQ: CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, published the proceedings of a roundtable of experts today, entitled, "Treating CLABSI: A Clinical and Economic Challenge".
 
The experts participating in the roundtable included Infectious Disease specialists:

• Ray Y. Hachem, MD, FIDSA, Professor of Medicine, Department of Infectious Diseases, Infection Control & Employee Health at U.T. M. D. Anderson Cancer Center;
• Mayur S. Ramesh, MD, Senior Staff Physician, Infectious Diseases, Henry Ford Health System;
• Mark E. Rupp, MD, Professor & Chief, Division of Infectious Diseases, University of Nebraska Medical Center; and,
• Sharon Welbel, MD, Associate Professor, Rush Medical College; Director, Hospital Epidemiology and Infection Control, Cook County Health and Hospital Systems.

Joining them were Stuart Gordon, MSN, RN, Clinical Education and Practice Specialist Vascular Access at Legacy Health; and Salman S. Mufti, MD, Vascular and Interventional Radiologist.

The roundtable panel was organized to discuss the treatment of catheter related bacteremias and focusing on the issue of the nidus of the bacteremia: the infected central venous catheter (CVC). Additionally, the roundtable brought the disciplines of venous nursing care and interventional vascular management to the core specialty of Infectious Disease. 

The panel concluded that Central Line Associated Bloodstream Infections (CLABSIs) are some of the most difficult infections to treat, and are a leading cause of healthcare-associated infections (HAIs) with substantial morbidity and mortality. Many of these patients need to have their CVCs 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. Salvaging the existing catheter may be essential – or at the very least, far preferable to remove and replace – when faced with the following clinical conditions:

• No vascular access
• A very sick patient (e.g., ICU, hypotensive, thrombocytopenic) 
• Need for long-term chronic parenteral therapy 
• Acute leukemia or lymphoma 
• Other comorbid conditions such as gross obesity.

"Citius has committed to providing much needed evidence that antibiotic lock therapy (ALT) is an attractive alternative to removing and replacing infected central lines," said Myron Holubiak, President and CEO of Citius. "Our phase 3 study comparing Mino-Lok to conventional ALT will be the largest and most definitive study of its kind conducted to date. 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 ALT locks that require substantially more dwell time and have not been thoroughly studied. We believe we will make a significant contribution to the body of knowledge on a variety of ALTs."

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.

About "Treating CLABSI: A Clinical and Economic Challenge"Citius Pharmaceuticals, Inc., commissioned Aesculapius Consulting, Inc. to conduct an expert roundtable discussion on the treatment of Central Line Associated Blood Stream Infections. The proceedings of those discussions are available as the sponsored publication "Treating CLABSI: A Clinical and Economic Challenge" and can be requested by contacting Citius Pharmaceuticals, Inc.

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.

Inserting And Removing Central Venous Catheters Cause Significant Discomfort In Cancer Patients And At Times Is Unnecessary

Source:  Citius Pharmaceuticals, Inc.

Use of Mino-Lok™ to disinfect CVCs could avoid patient discomfort while providing an effective alternative in the treatment of Central Line Associated Bloodstream infections (CLABSIs).

 Citius Pharmaceuticals, Inc. ("Citius") ("Company") (NASDAQ: CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, noted that a recent paper presented at the Infectious Disease Society of America (IDSA) meeting in early October (ID Week - 2017) showed that as many as half of the patients having their central venous catheters (CVCs) removed or inserted experience distress and/or catheter threading pressure, and about a third felt these symptoms to be severe.

Mr. Myron Holubiak, Chief Executive Officer of Citius, commented "We have believed for some time now, that the physical process of inserting and removing CVCs cause patients significant discomfort, and that having an anti-infective solution that could adequately disinfect a CVC thereby avoiding the removal and insertion of a new CVC would be of great benefit to patients from a symptom burden point of view."

There are currently no approved therapies to salvage infected central venous catheters.  CLABSIs are responsible for mortality rates up to 25% in some patients, and contribute to significant morbidities. Citius is currently enrolling patients for a phase 3 trial of Mino-Lok in the United States.

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.

Mino-Lok™ Phase 3 Clinical Trial Supplies Shipped to Sites

Source:  Citius Pharmaceuticals, Inc.

Mino-Lok recently received Fast Track designation by the FDA 

 Citius Pharmaceuticals, Inc. ("Citius") ("Company") (NASDAQ: CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, has announced that clinical trial supplies of Mino-Lok (minocycline/edetate/ethanol) have been sent to the University of Chicago Medical Center, and the Henry Ford Health System in Detroit, the first 2 clinical trial sites for the Mino-Lok phase 3 pivotal trial. When fully recruited, it is planned that there will be 50 participating sites, all located in the U.S.

The Mino-Lok solution is supplied as: 1) one stoppered glass vial containing lyophilized minocycline powder; and 2) one stoppered glass vial containing a sterile solution of edetate disodium in 25% ethanol. The mixing of the two vials will be prepared via standard pharmacy practices by reconstituting of the lyophilized vial of minocycline using the vial of sterile EDTA/ethanol solution.

Mr. Myron Holubiak, Chief Executive Officer of Citius, commented, "We have reached a key milestone in advancing this innovative product to an NDA.  Mino-Lok clinical trial supplies have been sent to two of the most prestigious institutions in the US in preparation for the initiation of our phase 3 pivotal trial. We have discussed the urgent need to find an alternative to CVC removal as an approach to treating Catheter Related Blood Stream Infections (CRBSIs).  We are very excited to finally begin our pivotal trial. We believe that the worldwide market potential for Mino-Lok exceeds $1 billion."

There are currently no approved therapies to salvage infected central venous catheters.  CRBSIs are responsible for mortality rates of up to 25% in some patients, and contribute to significant morbidities.

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.