NEW YORK, NY, August 20, 2013 – ( Accesswire) - Ohr Pharmaceutical Inc. (OHRP) today announced the initiation of an investigator-sponsored trial (“IST”) to evaluate the efficacy and safety of Squalamine Eye Drops for the treatment of macular edema secondary to retinal vein occlusion (RVO). The trial is being conducted by Dr. John Wroblewski at Cumberland Valley Retina Consultants in Maryland and is expected to enroll 20 treatment naïve patients. Dr. Wroblewski is a leading retinal specialist and recently joined Ohr Pharmaceutical’s scientific advisory board.
“The broad clinical potential of Squalamine has encouraged me to initiate a trial to look at this interesting drug candidate in retinal vein occlusion,” said Dr. John Wroblewski, retina specialist at Cumberland Valley Retina Consultants, and Principal Investigator of this IST. “Squalamine is known to inhibit multiple protein growth factors and it is now well established that agents with anti-VEGF properties have benefit for patients with RVO and improve visual acuity. The eye-drop formulation of Squalamine may provide a non-invasive approach that is more convenient for patients and physicians.”
Irach B. Taraporewala, Ph.D., CEO of Ohr Pharmaceutical added, “We are very pleased that Dr. Wroblewski has chosen to initiate this study. This is the second investigator led trial of Squalamine Eye Drops, underscoring the interest we are seeing in this experimental treatment within the medical community. There remains a significant unmet clinical need in retinal vein occlusion, which is the second most common cause of vision loss due to retinal vascular disease and a leading cause of blindness. We look forward to seeing the results of this study in 2014.”
Study OHR-004 is designed to evaluate the efficacy and safety of Squalamine Eye Drops for the treatment of macular edema secondary to central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO). Patients will receive Squalamine Eye Drops for the first two weeks of treatment, at which point they will then receive two successive injections of Lucentis® four weeks apart while continuing treatment with the eye drops. Patients will subsequently be randomized 1:1 at week 10 to either continue administering Squalamine Eye Drops or discontinue drops for the remainder of the 38-week study. Rescue injections of Lucentis will be administered as needed though week 38. The primary and secondary endpoints include visual acuity parameters, need for rescue retreatments, retinal thickness, vascular leakage, and change in area of non-perfusion.
About Squalamine Eye Drops
Squalamine is an anti-angiogenic small molecule with a novel intracellular mechanism of action, which counteracts multiple growth factors implicated in the angiogenesis process. 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, which require intravitreal injections directly into the eye. The drug, using an intravenous administration in over 250 patients in Phase I and Phase II trials for the treatment of wet-AMD, showed favorable biological effect and maintained and improved visual acuity outcomes. 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 (OHR-002) to evaluate the efficacy and safety of Squalamine Eye Drops for the treatment of wet-AMD is currently enrolling patients at more than twenty clinical sites in the U.S.
About Retinal Vein Occlusion
Retinal vein occlusion (RVO) is a common vascular disorder of the retina that occurs when the central retinal vein that drains the retina or one of its branches becomes blocked. It generally causes vision loss, the extent of which can vary greatly, depending on the severity and exact site of the vein occlusion. Early diagnosis and treatment of retinal vein occlusion and any complications may make a difference to the eventual level of visual loss. Severe vein occlusions can cause permanent visual loss, even if treated very early. RVO can be divided into two types: branch RVO (BRVO) and central RVO (CRVO), depending on the site of occlusion, with BRVO occurring more commonly than CRVO. Retinal vein occlusion will recur in about 1 in 6 people (either in the same eye or in the other eye) within five years of diagnosis and treatment. It is estimated that more than 16 million people worldwide are affected by RVO, according to a report published by the International Eye Disease Consortium (IEDC).
About Ohr Pharmaceutical Inc.
Ohr Pharmaceutical, Inc. (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 advancing its pipeline products currently in phase II clinical development: Squalamine Eye Drops for the treatment of the wet form of age-related macular degeneration and other neovascular ophthalmic disorders, 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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