NEW YORK, Nov. 20, 2012 /PRNewswire/ -- 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 through clinical efficacy trials. Jeffrey S. Heier, M.D. of Ophthalmic Consultants of Boston, and Daniel Roth, M.D., of Retina Vitreous Center in New Jersey 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.
"Squalamine eye drops have the potential to significantly advance the treatment of wet-AMD, both from a patient's convenience perspective as well as its unique mechanism of action which may provide distinct or additional benefits from our current anti-VEGF agents," commented Dr. Jeffrey Heier. "I am excited to be participating in the current trial and look forward to working closely with the Ohr team on this exciting approach."
"We are delighted to be working with thought leaders in the retina community of the caliber of Drs. Heier and Roth," commented Irach B. Taraporewala, Ph.D., CEO. "The reaction of the retinal physician community to our ongoing phase II Squalamine eye drop clinical trial has been very enthusiastic. We will continue to utilize our distinguished SAB to further expand into additional neovascular ophthalmic indications."
Biography for each SAB member is below:
Dr. Jeffrey S. Heier is one of the leading retinal clinical researchers in the country for new treatments in exudative and non-exudative macular degeneration, diabetic macular edema, venous occlusive disease, vitreoretinal surgical techniques and instrumentation, and diagnostic imaging of the retina. He serves on the Scientific Advisory Board or as Clinical Design Consultant to over twenty biotechnical or pharmaceutical companies, lectures nationally and internationally on retinal research and the innovative approach to the treatment of retinal diseases, and has authored numerous works in peer-reviewed journals. Dr. Heier received his medical degree from Boston University, then did his transitional internship and ophthalmology residency at Fitzsimons Army Medical Center. Between his internship and residency, Dr. Heier served as a physician in a Combat Support Hospital in the Persian Gulf War, for which he was awarded a Bronze Star. Dr. Heier then completed a vitreoretinal fellowship at Ophthalmic Consultants of Boston/Tufts University School of Medicine. Currently, he is the Director of the Vitreoretinal Service at Ophthalmic Consultants of Boston, and Co-director of the Vitreoretinal Fellowship. Dr. Heier is the Secretary of On-line Education and e-learning for the American Academy of Ophthalmology, Chairman of the Ophthalmic Services Committee for the New England Ophthalmological Society, Chairman of the Retina Society Credentials Committee, and an At-large Member of the American Society of Retina Specialists Executive Board.
Dr. Daniel Roth is an associate clinical professor at Robert Wood Johnson Medical School and a partner at the Retina Vitreous Center in New Jersey. He graduated summa cum laude and as valedictorian of his undergraduate class at Yeshiva University in New York City. He received his M.D. degree from Yale University, completed his residency in ophthalmology at the prestigious Bascom Palmer Eye Institute and fellowship in vitreoretinal disease and surgery at the world-famous Cleveland Clinic. He has been honored as a member of the Alpha Omega Alpha Honors Society, Retina Society and Macula Society. He has received a Fight for Sight and a Howard Hughes Research Fellowship, as well as AAO Achievement Award and ASRS Honor award. Dr. Roth was elected by his peers for inclusion in Best Doctors in America® and in the Guide to America's Top Ophthalmologists®. He has been a Principal Investigator for many clinical trials and sits on the committee for continuing medical education at the medical school. Dr. Roth has written chapters for numerous medical textbooks, and his research on eye disease has been published in many peer-reviewed medical journals.
About Squalamine Eye Drops
Squalamine is an anti-angiogenic small molecule with a novel intracellular mechanism of action, which counteracts not only Vascular Endothelial Growth Factor ("VEGF"), but also other angiogenic growth factors such as Platelet Derived Growth Factor ("PDGF"). 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 I and Phase II trials for the treatment of wet-AMD, with squalamine demonstrating favorable biological 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. A Phase II randomized, double blind, placebo controlled study to evaluate the efficacy and safety of Squalamine Eye Drops for the treatment of wet-AMD was initiated in September 2012.
About Ohr Pharmaceutical Inc.
Ohr Pharmaceutical Inc. (OTCBB: OHRP) 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 currently being investigated in clinical phase II trials: Squalamine Eye Drops for the treatment of the wet form of age-related macular degeneration, and OHR/AVR118 for the treatment of cancer cachexia. Additional information on the company can be found at www.ohrpharmaceutical.com.
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.
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SOURCE Ohr Pharmaceutical Inc.