Monday, May 14, 2018

Zomedica Signs Agreement With Seraph Biosciences for Innovative Veterinary Point-of-Care Diagnostic





 Source:  Zomedica Pharmaceuticals Corp.

Exclusive agreement intended to bring human medical diagnostic technology to the veterinary practice workflow

Zomedica Pharmaceuticals Corp. (NYSE American:ZOM) (TSX-V:ZOM), a veterinary diagnostic and pharmaceutical company, today announced it has entered into a development, commercialization and exclusive distribution agreement with Seraph Biosciences, Inc. (“Seraph”), a human biomedical device company. Under the terms of this agreement, Zomedica will have exclusive global veterinary industry rights to develop and market a novel pathogen detection system in the form of an innovative point-of-care diagnostic instrument.

Leveraging principles of Raman spectroscopy, Zomedica and Seraph are partnering to bring human diagnostic technology to veterinarians, beginning with the examination of urine and fecal samples. The diagnostic instrument, referred to as ZM-020 in Zomedica’s product pipeline, is expected to deliver multiple benefits, including speed of results and an enhanced workflow with minimal sample preparation time. Further, Zomedica’s development work will seek to expand the capabilities of in-clinic testing to include not only pathogen detection, but also genus- and species-level information. Because ZM-020 does not require pre-market regulatory approval for use with companion animals in the United States, Zomedica believes that it presents an attractive opportunity in terms of time to market and early revenue opportunities when compared to other diagnostic modalities.

“Our agreement with Seraph is another milestone in our efforts to bring cutting-edge innovations to veterinary practices,” said Gerald Solensky, Jr., CEO, Zomedica. “We chose to partner with Seraph because we believe that their platform will enable us to bring the best of human market technology to the in-house veterinary diagnostic lab bench, elevating the standard of care, enhancing practice workflow and driving practice profitability.”

“I couldn’t be more excited about our partnership with Zomedica and to be part of leveraging our Seraspec® platform to significantly improve the veterinary practice workflow,” said Jim Shanley, CEO, Seraph Biosciences. 

The agreement with Seraph covers development and validation of ZM-020. Zomedica will be responsible for development and validation, and their associated costs. Seraph will supply Zomedica, on an exclusive basis, with the hardware platform, associated software and the consumables to be developed under the agreement, pursuant to a rolling forecast, at prices specified in the agreement. Zomedica will be responsible for the marketing and sale of the hardware platform, associated software and the consumables. Marketing and sales are expected to begin in 2019, with an initial focus on canines and expanding into feline applications post launch.

The agreement, which is exclusive to the field of global veterinary diagnostic applications, has a term of seven years (subject to adjustment in certain circumstances) and automatically renews for additional one-year terms thereafter.

Zomedica has agreed to pay Seraph up-front fees of $500,000 and to issue to Seraph unregistered common shares having a value of $1,250,000, consisting of an aggregate of 641,717 common shares to be issued at an ascribed price of $1.9479 subject to receipt of TSX-V approval. Seraph is entitled to additional payments for development costs. Seraph will be entitled to receive up to an additional $7,000,000, payable 50 percent in cash and 50 percent in additional unregistered common shares, upon the achievement of a series of staged, specified milestones, including completion of laboratory studies and field studies, production and commercial shipment of products. Future issuances of shares will also be subject to TSX-V approval and will be priced relative to market at the time of issuance. Seraph is entitled to certain registration rights with respect to the common shares to be issued by Zomedica. In addition, Zomedica will pay Seraph license fees based on a percentage of gross profit.

“We believe that ZM-020 will enable us to make a significant improvement to the diagnostic workflow of the veterinary clinic,” said Stephanie Morley, DVM, Chief Operating Officer and Vice President of Product Development, Zomedica. “If we are successful in our development efforts, we believe that the ability to screen for a wide variety of pathogens with a single diagnostic instrument, beginning with urine and fecal samples, will be a game changer for the modern veterinary clinical team.”

ZM-020 is intended to use Raman spectral measurements to provide real-time, reagentless and fully automated identification of pathogens and disease indicators. ZM-020 builds upon recent advances in the field of Raman spectroscopy, a laser-based spectroscopy technique, to enable the identification of biological and biochemical signatures in complex biological samples. ZM-020 is comprised of a bench-top instrument and low-cost consumables intended to analyze unprocessed biological samples.  

About Zomedica
Based in Ann Arbor, Michigan, Zomedica (NYSE American: ZOM) (TSX-V: ZOM) is a veterinary diagnostic and pharmaceutical company creating products for companion animals (canine, feline and equine) by focusing on the unmet needs of clinical veterinarians. Zomedica’s product portfolio will include novel diagnostics and innovative therapeutics that emphasize patient health and practice health. With a team that includes clinical veterinary professionals, it is Zomedica’s mission to give veterinarians the opportunity to lower costs, increase productivity, and grow revenue while better serving the animals in their care. For more information, visit www.ZOMEDICA.com.

About Seraph Biosciences
Incorporated in 2016, Seraph Biosciences is a healthcare technology company dedicated to commercializing Seraspec® – a fully-automated pathogen identification platform capable of delivering near real-time pathogen detection. Based in Detroit, Michigan, Seraph’s mission is to provide disruptive biomedical solutions to front-line providers and their patients at the point of care.

 

Zomedica Pharmaceuticals Corp. Enters into License and Supply Agreement with Celsee, Inc. for Cancer Liquid Biopsy Platform


Source:  Zomedica Pharm aceuticals Corp. 

Targeting non-invasive veterinary cancer diagnostic assay

Zomedica Pharmaceuticals Corp. (NYSE American:ZOM) (TSX-V:ZOM) (“Zomedica” or “Company”), a veterinary pharmaceutical and diagnostic company, today announced it has entered into a license and supply agreement with Celsee, Inc. (“Celsee”), an innovator of progressive rare cell capture, characterization and retrieval products in the emerging field of liquid biopsy. Under the terms of the agreement, Zomedica will have animal health exclusive global rights to develop and market Celsee’s liquid biopsy platform for use by veterinarians as a cancer diagnostic.

A liquid biopsy is a blood test with the potential to detect the presence of circulating tumor cells in the blood. Circulating tumor cells, commonly referred to as CTCs, are cells that have shed from a primary tumor into neighboring blood vessels and are transported throughout the body’s circulatory system. The detection of CTCs in the blood could indicate a cancer diagnosis without the need for an invasive tissue biopsy.

“Liquid biopsy is cutting-edge technology in human medicine right now and we’re excited about the opportunity to develop and market this platform for use in veterinary medicine,” stated Gerald Solensky, Jr., Chief Executive Officer at Zomedica. “We selected the Celsee platform because of the ease of use, workflow simplicity, and flexibility to use our novel canine biomarkers. If we successfully develop Celsee’s technology, we believe we will be able to provide veterinarians with a best-in-class product they deserve when caring for their patients.”

“Our automated sample-to-result liquid biopsy platform not only exceeds current efficiency standards but also reduces the complexity involved in the capture and counting of circulating tumor cells,” stated Kalyan Handique, PhD, President at Celsee. “This agreement means we can continue to validate our technology and substantiate its value for use in prognosis and therapeutic decision making in additional species.”

Using Celsee’s liquid biopsy platform, Zomedica initially intends to develop and market ZM-017, a non-invasive diagnostic assay or blood test that helps veterinarians diagnose cancer in canines. The Veterinary Cancer Society estimates that 50 percent of dogs over the age of 10 will develop cancer and one in four dogs at some stage in their life will develop cancer. Many more canine cancer cases may go undetected due to cost constraints and other factors.

If the development of ZM-017 is successful, Zomedica expects that ZM-017 will provide veterinarians with a faster, more affordable, and less invasive test for cancer in canines compared to existing methods, which can be expensive and cost prohibitive for pet owners. Zomedica estimates the out-of-pocket cost incurred by pet owners for ZM-017 will be less expensive compared to current testing methods, which can cost thousands of dollars depending on the presentation and type of suspected cancer.

Zomedica expects to commence clinical validation of Celsee’s CTC detection technology in the first half of 2018 to determine whether CTCs can be detected in canines to confirm the existence of certain cancers with a high level of sensitivity and specificity. Assuming the successful completion of the technology validation, Zomedica expects to commence the marketing of ZM-017 during the second half of 2018, as there is no pre-market regulatory burden in the United States.

The agreement with Celsee covers the development and commercialization of liquid biopsy assays and related consumable for the detection of cancer in companion animals. The parties will initially focus on the development of a liquid biopsy for use in canines. Zomedica will be responsible for the clinical development and commercialization of the assays. Celsee will supply Zomedica on an exclusive basis with the assays and the consumables for the products to be developed under the agreement pursuant to a rolling forecast to be provided by Zomedica at prices specified in the agreement. Zomedica will be responsible for the marketing and sale of the assays and the related consumables. The agreement, which is exclusive in the field of veterinary cancer diagnostic applications, has a term of seven years (subject to termination in certain circumstances) and automatically renews for additional one-year terms thereafter.

Zomedica has agreed to pay Celsee up-front fees of $500,000 and to issue to Celsee unregistered common shares having a value of $250,000, consisting of an aggregate of 112,314 common shares to be issued at an ascribed price of $2.2259, subject to receipt of TSX-V approval. Celsee is entitled to additional payments aggregating up to an additional $1 million, payable 50 percent in cash and 50 percent in additional unregistered common shares, upon the achievement of specified milestones—namely, completion of product development (in respect of 50 percent of the foregoing cash and share payments) and upon successful completion of manufacturing (as to the remaining 50 percent of the foregoing cash and share payments). Future issuances of shares will also be subject to TSX-V approval and will be priced relative to market at the time of issuance. Celsee is entitled to certain registration rights with respect to the common shares issued by Zomedica under the agreement.

About Zomedica
Based in Ann Arbor, Michigan, Zomedica is a veterinary pharmaceutical and diagnostic company creating products for companion animals (canine, feline and equine) by focusing on the unmet needs of clinical veterinarians. Zomedica’s product portfolio will include innovative therapeutics and diagnostics that emphasize patient health and practice health. With a team comprised of clinical veterinary professionals, it is Zomedica’s mission to give veterinarians the opportunity to lower costs, increase productivity, and grow revenue while better serving the animals in their care. For more information, visit www.ZOMEDICA.com.

About Celsee
Celsee Inc., a privately-held company, develops, manufactures, and markets integrated nanotechnology platforms for automated label-free isolation, analysis and retrieval of viable rare cells direct from blood. The C-Prep platforms enable single cell resolution facilitating the study of circulating tumor cells and individual cellular heterogeneity. Years of innovation allow the scaled capture of up to tens or hundreds of thousands of viable cells for culture and multi-omics characterization for expanded analytical sensitivity. The simplicity and efficacy of the workflows are coupled with market leading time for simplified sample to results.

 

Wednesday, May 2, 2018

Arch Therapeutics Provides Update on 510(k)

Source:  Arch Therapeutics, Inc.

Company files pre-submission with FDA for feedback on proposed plan to address FDA comments before next medical device submission; Expecting to file 510(k) during Q3

Arch Therapeutics, Inc. (OTCQB:ARTH) ("Arch" or the "Company"), developer of liquid, gel and solid hemostatic and wound care devices, today announced that it has utilized the Food and Drug Administration’s (FDA, "the agency") pre-submission process to submit a proposed development strategy to the FDA to address the agency’s comments on its previous 510(k) submission for its AC5 Topical Gel product.

As previously reported, Arch voluntarily withdrew its 510(k) notification for its medical device AC5 Topical Gel from the FDA after receiving comments from the FDA late in the review process for which a complete response could not be provided within the FDA's statutorily-mandated 90-day review period. We are proceeding with our disclosed intent to gain a better understanding of the agency's comments and submit a new 510(k) as soon as possible, which would follow appropriate discussion, agreement and completion of a plan.

The 510(k) package previously submitted by Arch included a comprehensive battery of tests. The agency requested further evidence that the product does not cause sensitization in humans. While we respectfully disagree that further evidence should be necessary, we are working with the agency to address their outstanding comments, and we have determined that the most expeditious path involves providing additional data.

In order to provide a comprehensive response to the agency and minimize further delay, we consulted with several medical experts and developed a strategy to perform a small, three-month long, non-invasive human study to provide the additional data to the FDA. The Company has presented this proposal to the FDA via the pre-submission process with the intention of ensuring that the strategy will address their questions. Based on the body of scientific data that the Company has generated, including favorable results in a prior animal test for sensitization, we anticipate supportive findings in a human sensitization test.

Terrence Norchi, MD, President & Chief Executive Officer of Arch, commented, “We determined it most prudent to submit a pre-submission filing to provide the agency adequate time for full review of both the information we presented and our proposal. We expect this phase of the review process by the agency to last roughly two months, after which we would expect to initiate the proposed study at a cost of approximately $100,000.”

Assuming that the FDA agrees with the Company’s proposed development plan and the additional testing is completed when expected, Arch expects to submit the 510(k) later in the third quarter of 2018. Arch also expects to file a CE mark in Europe for AC5 in the second half of 2018.
Dr. Norchi added, “This puts us on target to submit the 510(k) later in the third calendar quarter of 2018 and for us to hear back by the end of 2018 with possible commercialization mid-2019. We believe that the additional testing will answer the agency’s questions and be helpful in future regulatory submissions.”

Arch remains focused on manufacturing scale-up, clinical regulatory strategy, developing commercial partnerships, advancing intellectual property 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.

Dermatologic Surgery Publishes Clinical Data on Arch Therapeutics’ AC5™ in a Topical Application

Source:  Arch Therapeutics, Inc.

Peer-Reviewed Paper Concludes That AC5™ Provided Safe and Effective Hemostasis Regardless of Whether Patients Were Taking or Not Taking Antiplatelet Therapy

Positive data from a clinical study of patients undergoing dermatologic surgery and treated with the AC5™ was published in the peer-reviewed journal Dermatologic Surgery, the official journal of the American Society for Dermatologic Surgery. The study was sponsored by Arch Therapeutics, Inc. (OTCQB: ARTH) (“Arch” or the “Company”) and conducted by an independent research organization in Ireland. The results in the manuscript, titled “First Safety and Performance Evaluation of T45K, a Self-Assembling Peptide Barrier Hemostatic Device After Skin Lesion Excision” by Rahmani et al. show that AC5™ was safe and rapidly achieved hemostasis agnostic to the presence of antiplatelet medication. SAPB-T45K is a development name for AC5. The paper has been published as Open Access, and can be accessed online at the journal website.

The authors report that in this single-blind study, wounds were randomized to receive AC5 or control treatment after sequential shave excision of two lesions in the same patient. This design allowed patients to serve as their own controls. Patients and clinical assessors were blind to treatment allocation. Safety was assessed at treatment, Day 7 and Day 30. Performance was evaluated using time to hemostasis (TTH) and a published wound scoring system, with a subgroup analysis for patients with or without antiplatelet therapy (aspirin). A total of 46 patients (10 of which, or 22% of the study group, received antiplatelet therapy) received randomized AC5 or control treatment for their two wounds. Safety assessments were similar for AC5 and the control treatment, and wound scores reflected normal healing in both wound groups. AC5 demonstrated significantly faster median TTH (24.5 [range, 7–165] seconds) compared with the control treatment (44 [10–387] seconds), for a 41% median TTH reduction (18 [95% confidence interval, 7–35] seconds, and this result was statistically significant (p < 0.001, Wilcoxon signed rank test). AC5 use resulted in an identical median TTH of 24 seconds in the group of patients taking antiplatelet therapy and the group not taking antiplatelet therapy. In contrast, the median TTH for the control treatment was 90 and 40 seconds for the groups of patients taking or not taking antiplatelet therapy, respectively. 

Safety assessments in the study included a full battery of laboratory blood tests, assessment of wound healing scores and observation for any systemic reactions. Terrence W. Norchi, MD, President and CEO of Arch Therapeutics, said, “This report represents the first clinical study of both the safety and performance of AC5. The primary purpose of the study was to assess safety. The safety profile of a topical agent is important, and AC5’s safety profile was similar to that of saline and consistent with a normal healing pattern.”

The senior author of the paper and Principle Investigator of the study, Professor Jack Kelly MB MD FRCS(Plast), is a Consultant Plastic Surgeon and Professor of Plastic Surgery at Galway University Hospital, Galway Ireland. Professor Kelly said, “According to a 2015 report, almost half of the patients undergoing elective surgery are taking anticoagulant or antiplatelet medications to prevent potentially life-threatening problems, such as strokes, heart attacks and pulmonary emboli. When these patients require surgery or even a minor procedure, the surgeon often decides to discontinue the drug, weighing the risk of bleeding against the risk of stroke or other event for which the medication was prescribed. The consistent performance of AC5 regardless of the patient’s antiplatelet medication support the potential of AC5 as an important option to control bleeding without having to stop the medication.” In animal studies, AC5 has also demonstrated this consistent performance in the presence of various anticoagulant and antiplatelet medications.

Topline results of the study were previously reported in a press release issued by the Company on August 15, 2016, which can be accessed at the company’s website.

Dr. Norchi further commented, “We continue to develop our exciting technology for wound care and biosurgical applications. As our priority, we are committed to continued collaboration with the FDA and plan to submit a new 510(k) notice for AC5 Topical Gel as soon as possible following further discussion with the agency. We will provide a more detailed update when the plan is finalized.”

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 Favorable Results in Repeat Dose Testing of AC5™ for Subchronic Systemic Toxicity

Source:  Arch Therapeutics, Inc.

AC5 was comparable to control when dosed 16 times over two months

Arch Therapeutics, Inc. (OTCQB:ARTH) (“Arch” or the “Company”), developer of novel liquid, gel and solid hemostatic and wound care devices reported that AC5™ Topical Gel (AC5™) was found to be biocompatible in testing designed to investigate subchronic systemic toxicity. The subchronic systemic testing, which involved repeat, frequent dosing over 8 weeks, is one of a panel of biocompatibility evaluation endpoints recommended by US FDA regulatory guidelines for devices such as AC5 to allow use in humans.

This study was designed to provide information on the health hazards that might arise from repeated exposure to AC5. A total of 80 animals (40 male and 40 female) were assigned to either a group dosed with one of three dose levels of AC5 or control. Accordingly, AC5 solutions and control were administered two times per week by intraperitoneal administration for eight weeks (16 doses). Animals were observed for signs of toxicity before and immediately post administration and daily throughout study duration of 90±2 days. At the end of the survival period, standard blood tests, macroscopic exams and target tissue histopathologic evaluations were conducted.

All animals appeared normal over the course of the study and survived to the scheduled end of the study.  Clinical observations throughout the study, including weight, food consumption, blood tests, and other observations were comparable among animals receiving AC5 or control. Gross pathology and histopathology differences for AC5 were minimal and not clinically significant.

This test was conducted in compliance with the International Organization for Standardization (ISO) and in full accordance with the Food and Drug Administration’s Good Laboratory Practice (GLP) regulations (21 CFR Part 58).

Arch Therapeutics President and CEO Terrence Norchi, MD, stated, “This is an important study in the battery of biocompatibility tests in animals needed to demonstrate the safety of AC5, because it supports that even with repeat dosing over two months, AC5 was well tolerated and not associated with clinical toxicity. The favorable results demonstrated in this study are consistent with the other safety studies conducted to date, and provide important new safety information pertaining to repeat, long-term exposure to AC5. We continue to be pleased with the data generated.”

In July, Arch submitted a 510(k) to the U.S. FDA for AC5 Topical Gel, which is under active review.

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.

Safety, Income & Growth Declares First Quarter 2018 Common Stock Dividend

Source:  Safety, Income & Growth Inc.

Safety, Income & Growth Inc. (NYSE:SAFE) announced today that the Company’s Board of Directors has declared common stock dividends of $0.15 per share for the first quarter of 2018. The dividend represents an annualized rate of $0.60 per share and is payable on April 13, 2018 to holders of record on March 30, 2018.

Safety, Income & Growth Inc. (NYSE:SAFE) is the first publicly traded company that focuses on acquiring, owning, managing and capitalizing ground leases. The Company seeks to provide safe, growing income and capital appreciation to shareholders by building a diversified portfolio of high quality ground leases. The Company, which is taxed as a real estate investment trust (REIT), is managed by its largest shareholder, iStar Inc. Additional information on SAFE is available on its website at www.safetyincomegrowth.com.


Safety, Income & Growth Originates $50 Million of New Ground Leases

Source:  Safety, Income & Growth Inc.

Safety, Income & Growth Inc. (NYSE:SAFE), the leading company focused on ground leases, announced it has originated two new ground leases totaling $50 million with The Dilweg Companies. 

Dilweg utilized a SAFE Ground Lease™ to successfully recapitalize Regency Lakeview, a two-building office campus comprising 376k square feet on 27 acres in Cary, NC. The property is in the center of the vibrant “Research Triangle” between Raleigh, Durham, and Chapel Hill. Regency Lakeview has convenient access to US-64 offering a short drive to Raleigh-Durham International Airport and downtown Raleigh. The campus is currently undergoing a nearly $6 million renovation to further enhance the space.

In addition, SAFE’s custom-tailored ground lease facilitated Dilweg’s acquisition of Pershing Point, a 7-story, 410k square foot office building on Peachtree Street in Midtown Atlanta. The property is well-located in a top 10 MSA and has excellent access to I-75, I-85, and GA-400 via the Peachtree Street Connector. Dilweg plans to invest approximately $19 million in capital and tenant improvements to reposition the asset as creative office space.

The SAFE Ground Lease™ provided low-cost, long-duration solutions that enabled Dilweg to unlock value and achieve better returns at both properties.

“These transactions show how a well-structured, modern SAFE Ground Lease™ can be employed to create value for customers at acquisition and recapitalization. The low-cost, flexible structure is immediately accretive, particularly when compared to alternative financing options,” said Tim Doherty, Head of Ground Lease Investments. “We are building momentum as the marketplace is realizing how our brand of ground leases offers an innovative way for our clients to maximize their returns.”

Safety, Income & Growth Inc. (NYSE: SAFE) is the first publicly traded company that focuses on acquiring, owning, managing and capitalizing ground leases. The Company seeks to provide safe, growing income and capital appreciation to shareholders by building a diversified portfolio of high quality ground leases. The Company, which is taxed as a real estate investment trust (REIT), is managed by its largest shareholder, iStar Inc. Additional information on SAFE is available on its website at www.safetyincomegrowth.com