NEW YORK, NY--(Marketwire - May 01, 2012) -
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Ohr Pharmaceutical Inc. (OTCBB: OHRP) today announced the formation of a Scientific Advisory Board (“SAB”) comprised of leading retinal ophthalmology experts to assist in advancing the Squalamine eye drop program into clinical efficacy trials. Thomas A. Ciulla, M.D. of the Midwest Eye Institute, Michael J. Elman, M.D. of the Elman Retina Group, and Jason S. Slakter, M.D. of the Vitreous Retina Macula Consultants of NY group have agreed to join as members of the SAB. These highly regarded experts will advise the company on its clinical programs, regulatory strategy and provide strategic guidance to support the development of Squalamine in multiple neovascular ophthalmic clinical indications each with sizable commercial markets.
“I am very pleased to be joining the Ophthalmic Scientific Advisory Board of Ohr Pharmaceutical,” commented Dr. Slakter. “The Company’s eye drop for treating wet-AMD would potentially offer patients a convenient, self-administered, treatment alternative or adjunct to currently used intravitreal injections directly into the eye. This would be an exciting and significant advancement in the therapy of wet-AMD should the therapy be proven effective.”
“We are excited to be working with key opinion leaders in the retina community,” stated Irach B. Taraporewala, Ph.D., CEO. “Their prior experience in fostering the development of numerous FDA approved therapeutics, including Eylea® and Lucentis®, will provide us with immeasurable assistance as we move the Squalamine eye drop program into a clinical trial for the treatment of wet-AMD in the near future.”
Biographies for each SAB member are below:
Dr. Thomas Ciulla, M.D., is a retinal physician who serves as Director of the Midwest Eye Institute in Indianapolis, IN. Dr. Ciulla is board-certified in ophthalmology and has served as Co-Director of the Retina Service and Associate Professor of Ophthalmology on the faculty of the Indiana University School of Medicine, prior to entering private practice at the Midwest Eye Institute. Through Midwest Eye Institute, Dr. Ciulla performs clinical studies in macular and retinal diseases, with particular emphasis on age-related macular degeneration, diabetic retinopathy and retinal occlusions. He has been the principal investigator and sub-investigator on clinical trials sponsored by the NIH and NEI and has served as a consultant, Principal Investigator or Medical Monitor for numerous ophthalmic pharmaceutical companies. He has served on the Advisory Boards of numerous large medically affiliated companies, has lectured nationally and internationally, has authored nearly 100 publications, and co-edited two major textbooks.
Dr. Michael Elman, M.D., is a board certified ophthalmologist and has practiced ophthalmology for over 30 years, specializing in diseases of the retina and vitreous. Author of more than 150 publications on retinal diseases and surgery, Dr. Elman is an Assistant Professor of Ophthalmology at the Johns Hopkins University School of Medicine. He is currently the Director of Retina Surgery at Franklin Square Hospital. Dr. Elman directed the Clinical Research Unit at the University of Maryland and was bestowed the Young Scholar Award for the entire University of Maryland. He serves as the Chairman of Executive Committee of the National Eye Institute’s Diabetic Retinopathy Clinical Research Network (DRCRnet). He was also Study Chairman of the DRCRnet’s Protocol I, a national collaborative clinical trial that recently revolutionized the treatment of diabetic macular edema.
Dr. Jason Slakter, M.D., of the Vitreous Retina Macula Consultants of New York is an internationally recognized retinal and macular disease specialist, and is the Founder and Director of the Digital Angiography Reading Center (DARC) in New York, which is the largest center for ocular image evaluation for clinical trials of posterior segment disease with over 800 certified clinical sites in over 40 countries worldwide. As Director of DARC, a principal investigator of many clinical trials, and a pharmaceutical industry consultant, Dr. Slakter has played a major role in the discovery, development and commercialization of treatments for age-related macular degeneration, diabetic retinopathy, retinal vascular disease, central serous chorioretinopathy and other retinal diseases. He has provided critical assistance in the design of clinical trials at all stages of development, and has participated in numerous meetings with the FDA. Dr. Slakter has published more than 85 papers and book chapters.
About Ohr Pharmaceutical Inc.
Ohr Pharmaceutical Inc. (OTCBB: OHRP) (www.ohrpharmaceutical.com) is a pharmaceutical company dedicated to the clinical development of new drugs for underserved therapeutic needs in large and growing markets. The company is focused on two lead compounds: Squalamine eye drops for the treatment of the wet form of age-related macular degeneration, and OHR/AVR118 for the treatment of cancer cachexia, currently being investigated in a Phase II trial.
About Squalamine
Squalamine is a small molecule anti-angiogenic with a novel intracellular mechanism of action, that counteracts not only Vascular Endothelial Growth Factor (“VEGF”) but also other angiogenic growth factors such as Platelet Derived Growth Factor (“PDGF”) with high potency at nanomolar concentrations. Recent clinical evidence has shown PDGF to be an additional key target for the treatment of wet-AMD. Using the intravenous formulation in over 250 patients in Phase 1 and Phase 2 trials for the treatment of wet-AMD, Squalamine demonstrated favorable biologic effect and maintained and improved visual acuity outcomes, with both early and advanced lesions responding. The previous IV formulation had been awarded fast track status and a Special Protocol Assessment for a phase III registration study from the U.S. Food and Drug Administration (“FDA”). Ohr Pharmaceutical has developed a novel eye drop formulation of squalamine for the treatment of wet-AMD designed for self-administration which may provide several potential advantages over the FDA approved current standards of care, Roche/Genentech’s Lucentis® and Regeneron’s Eylea®, which require intravitreal injections directly into the eye. Preclinical testing has demonstrated that the eye drop formulation is both safe to ocular tissues and achieves in excess of target anti-angiogenic concentrations in the tissues of the back of the eye.
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995:
This news release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made only as the date thereof, and Ohr Pharmaceutical undertakes no obligation to update or revise the forward-looking statement whether as a result of new information, future events or otherwise. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of various factors and uncertainties, including the future success of our scientific studies, our ability to successfully develop products, rapid technological change in our markets, changes in demand for our future products, legislative, regulatory and competitive developments, the financial resources available to us, and general economic conditions. For example, there can be no assurance that Ohr will be able to sustain operations for expected periods. Shareholders and prospective investors are cautioned that no assurance of the efficacy of pharmaceutical products can be claimed or assured until final testing; and no assurance or warranty can be made that the FDA or Health Canada will approve final testing or marketing of any pharmaceutical product. Ohr’s most recent Annual Report and subsequent Quarterly Reports discuss some of the important risk factors that may affect our business, results of operations and financial condition. We disclaim any intent to revise or update publicly any forward-looking statements for any reason.
Contact:
Investor Relations:
Tel: (877) 215-4813
Email: ir@ohrpharmaceutical.com
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