Ohr Pharmaceutical Achieves 50% Enrollment Milestone in Squalamine Eye Drop Phase II Clinical Trial Interim Results of the Wet-AMD Study Expected in the Second Quarter of 2014
NEW YORK, July 10, 2013 /PRNewswire/ -- Ohr Pharmaceutical, Inc. (NasdaqCM:OHRP), a pharmaceutical company focused on the development of novel therapeutics for large unmet medical needs, today announced that it has enrolled the first 60 patients in the Company's ongoing OHR-002 Phase II clinical trial evaluating Squalamine Eye Drops for the treatment of the wet form of age-related macular degeneration ("wet-AMD"). The study is a randomized, double blind, placebo controlled study enrolling patients at more than twenty clinical sites in the U.S.
"We are excited to have reached the halfway point in the enrollment of our Squalamine Eye Drop study," said Dr. Irach B. Taraporewala, CEO of Ohr. "This milestone sets the stage for the planned interim analysis once the 60 patients complete the nine month treatment protocol, and we expect the data to be available in the second quarter of 2014."
"I am pleased with the continued progress in the trial to evaluate Squalamine Eye Drops for exudative AMD," commented Dr. Jason Slakter, retinal disease specialist at Vitreous-Retina-Macula Consultants of NY, and member of Ohr's scientific advisory board. "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 could be a significant advancement in the future treatment of wet-AMD."
Study OHR-002 is a randomized, double blind, placebo controlled Phase II study to evaluate the efficacy and safety of Squalamine Eye Drops for the treatment of wet-AMD. The study will enroll 120 treatment naive wet-AMD patients at more than twenty clinical sites in the U.S., who will be treated with Squalamine Eye Drops or placebo eye drops twice daily for a nine month period. The primary and secondary endpoints include visual acuity parameters, need for rescue intravitreal injections, and safety. The protocol includes an interim analysis upon the completion of the treatment period in 50% of the patients (60). More information on the clinical trial can be found at clinicaltrials.gov.
About Ohr Pharmaceutical, Inc.
Ohr Pharmaceutical, Inc. (NasdaqCM: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 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. Stockholders 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 on Form 10-K and subsequent Quarterly Reports on Form 10-Q 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.
Ohr Pharmaceutical, Inc.
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