NEW YORK, NY--(Marketwire - June 06, 2012) -
Ohr Pharmaceutical Inc. (OTCBB: OHRP
) today announced the addition of two prominent ophthalmologists to its Scientific Advisory Board ("SAB") comprised of leading retinal ophthalmology experts to assist in advancing the Squalamine eye drop program into clinical efficacy trials. David S. Boyer, M.D. of Retina-Vitreous Associates Medical Group in the Los Angeles metropolitan area, and Lawrence J. Singerman, M.D., of Retina Associates of Cleveland will be joining 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.
"Ohr Pharmaceutical's Squalamine eye drops, conveniently self-administered by the patient, could potentially provide great benefits to patients with wet-AMD and other ophthalmological disorders," commented Dr. Lawrence Singerman. "I look forward to working with the Ohr team on this exciting and potentially transformational product."
"We are pleased to be working with thought leaders in the retina community of the caliber of Drs. Boyer and Singerman," commented Irach B. Taraporewala, Ph.D., CEO. "Their addition to our ophthalmic SAB, together with their past experience in the clinical advancement of numerous FDA approved retinal therapeutics, including Eylea® and Lucentis®, will immensely help the company move the Squalamine eye drop program forward into its first clinical trial, which is expected to begin in the third quarter of 2012."
Biographies for each SAB member are below:
David S. Boyer, M.D. is a Board-certified ophthalmologist specializing in treatment of diseases of the retina and vitreous and is a senior partner at Retina-Vitreous Associates Medical Group with offices in Los Angeles, Beverly Hills, North Hollywood, Torrance, Santa Clarita and Pasadena, California. Dr. Boyer, who is also a Clinical Professor with the University of Southern California, has an extensive research background. He has been involved in trials studying age-related macular degeneration, diabetic retinopathy, and cytomegalovirus retinitis. His professional affiliations include the Los Angeles Medical Association, Los Angeles Eye Society, American Board of Ophthalmology, Discovery Fund for Eye Research, American Academy of Ophthalmology, California Medical Association, Retina Society, Macula Society, American Medical Association and Retinitis Pigmentosa International. A widely-published author and avid lecturer, Dr. Boyer has been on the advisory boards for Alcon, Allergan, Eyetech, Genentech, iCo, ISIS, Novartis, Neurotech, Pfizer, Regeneron and the Macular Degeneration Partnership. He is a member of the board of directors of the Research Study Club, Discovery Fund for Eye Research and has been a member of the board of directors of the American Diabetes Association Los Angeles Chapter and the Center for the Partially Sighted.
Lawrence J. Singerman, M.D. is a Board-certified ophthalmologist specializing in the treatment of retina and vitreous disorders. After completing his retinal training at the Wilmer Ophthalmological Institute of Johns Hopkins University, Dr. Singerman established Retina Associates of Cleveland in 1974. With 8 other retina specialists and over 100 employees, the practice sees patients throughout Northern Ohio. Dr. Singerman is active in the field of clinical research and has been a principal investigator in more than 75 multicenter clinical trials sponsored by NIH and pharmaceutical companies. Many of these studies of treatments for diabetic retinopathy, age-related macular degeneration, and other vitreoretinal diseases have led to FDA-approval of new drugs. Dr. Singerman serves on editorial boards for major ophthalmology journals. He has edited two textbooks and has authored a book and over 300 publications. He has also chaired or organized over 80 national and international courses and symposia on macular and retinal vascular disease. In 1977, Dr. Singerman founded the Macula Society, an international association of leading investigators and clinicians in the field of retinal diseases. He has been continuously re-elected to the position of Executive Secretary of the Society. In 1999, he received the Society's J. Donald M. Gass Medal for Outstanding Contributions in the Study of Macular Diseases, and in 2009 he was awarded the Arnall Patz Medal for outstanding contributions in the study of retinal vascular diseases. Dr. Singerman was the Vice Chair of the Council of the American Academy of Ophthalmology and a member of the Executive Committee of the Academy's Board of Directors. In 2006, he was given the Academy's Life Achievement Honor Award.
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.
Squalamine is an anti-angiogenic small molecule 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. The drug was previously studied using an intravenous administration in over 250 patients in Phase 1 and Phase 2 trials for the treatment of wet-AMD, with squalamine demonstrating favorable biologic effect and maintained and improved visual acuity outcomes, with both early and advanced lesions responding. Ohr Pharmaceutical has developed a novel eye drop 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. In May 2012, the Squalamine eye drop program was granted Fast Track Designation by the U.S. FDA.
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.