Ohr Pharmaceutical Initiates Phase II Trial of Squalamine Eye Drops for the Treatment of Wet Macular Degeneration
NEW YORK, Sept. 24, 2012 /PRNewswire/ -- Ohr Pharmaceutical (OTCBB: OHRP-News) today announced the initiation of a Phase II clinical trial to evaluate the efficacy and safety of Squalamine Eye Drops for the treatment of the wet form of age-related macular degeneration ("wet-AMD"). The randomized, double blind, placebo controlled study will enroll patients at twenty one ophthalmology treatment centers across the United States. Interim results are expected in the fourth quarter of 2013.
"An eye drop to treat wet-AMD and ophthalmic neovascular disorders would be transformational for the large patient populations currently taking chronic treatments of Lucentis® or Eylea®, both of which are injected directly into the eye," stated Dr. Irach B. Taraporewala, CEO of Ohr. "In the past few months we have achieved several major milestone events including the completion of a financing at favorable terms as well as the U.S. FDA granting Fast Track designation to our Squalamine Eye Drop program. We are very pleased to announce the initiation of our Phase II trial today which we stated to investors would start by the end of the third quarter."
"I am very excited to be participating in the clinical study of this potentially groundbreaking product," commented Dr. Lawrence Singerman, of Retina Associates of Cleveland, and a member of Ohr's Scientific Advisory Board. "The addition of a self-administered eye drop to treat wet-AMD as an alternative or adjunctive therapy to our current treatment modalities would be a tremendous step forward for patients who suffer from this debilitating condition."
Dr. Michael Elman, investigator at Elman Retina, and a member of Ohr's Scientific Advisory Board, added, "The drug's unique mechanism of action may provide additional clinical advantages well beyond the obvious patient convenience of a self administered eye drop. This could translate into the eye drop's additional use in other retinal disorders which involve neovascularization and affect millions of patients."
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 twenty one clinical sites in the U.S., who will be treated with Squalamine 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 (approximately 60). More information on the clinical trial can be found at clinicaltrials.gov.
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") with high potency. 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.
About Wet Age-Related Macular Degeneration
Age-related macular degeneration ("AMD") is a medical condition which usually affects older adults and generally results in a loss of vision. AMD occurs in "dry" (non-exudative) and "wet" (exudative) forms. Wet-AMD is the advanced form of macular degeneration that robs the elderly of their eyesight, and involves the formation of abnormal and leaky blood vessels in the back of the eye behind the retina, through a process known as choroidal neovascularization ("CNV"). The wet form accounts for approximately 15 percent of all AMD cases, yet is responsible for 90 percent of severe vision loss associated with AMD. According to the National Eye Institute (NEI), the prevalence of wet-AMD among adults 40 years or older in the U.S. alone is estimated at 1.75 million people. In addition, more than 200,000 new cases are diagnosed yearly in the U.S.
About Ohr Pharmaceutical Inc.
Ohr Pharmaceutical Inc. (OTCBB:OHRP-News) (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 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.
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.
Ohr Pharmaceutical Inc.
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