NEW YORK, NY--(Marketwire - July 10, 2012) -
Ohr Pharmaceutical (OTCBB: OHRP
) today announced positive results from a long term safety study of Squalamine eye drops being developed for the treatment of the wet form of age-related macular degeneration ("wet-AMD") and other ophthalmic neovascular disorders. The data from the study indicates that the novel eye drop is safe when applied to the eye with no signs of ocular or systemic toxicity on long term administration. The Squalamine eye drop program was recently awarded Fast Track designation by the U.S. FDA, and the company presented data at scientific meetings which highlighted the clinical relevance of Squalamine eye drops for the treatment of wet-AMD.
"We are excited with the continued positive results being generated on our Squalamine eye drop program demonstrating its safety, tolerability, and consistent therapeutically relevant concentrations in the eye," stated Dr. Irach B. Taraporewala, CEO of Ohr. "An eye drop for wet-AMD would be transformational for the large patient population currently taking chronic treatments of Lucentis® or Eylea® injected directly into the eye. The program continues to progress rapidly and we expect to initiate a clinical Phase II trial in Q3 2012 for the treatment of wet-AMD."
In a 26-week safety and toxicity study in male and female Dutch belted rabbits, Squalamine or placebo eye drops were administered via topical instillation twice a day ("BID") in both eyes. Ophthalmoscopic examinations were conducted throughout the study period to assess ocular toxicity (irritation, redness, swelling, discharge). Blood and urine samples for clinical pathology evaluations were collected, and blood samples for determination of the plasma concentrations of Squalamine eye drops and toxicokinetic evaluations were collected from all animals at designated time points. At study termination, necropsy examinations were performed, and organs and optical tissues were microscopically examined.
No adverse effects of treatment were observed in any of the parameters evaluated including clinical findings, body weights, food consumption, ocular irritation, hematology, coagulation, clinical chemistry, urinalysis and macroscopic pathology examinations. Importantly, ophthalmoscopic examinations indicated no signs of clouding of the lens, no corneal opacities or deposits, and no increase in intraocular pressure. In addition, microscopic histopathology evaluations on ocular tissues were normal. Squalamine also did not build up in plasma over long term administration, indicating reduced potential for systemic side effects.
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 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.
About Wet Age-Related Macular Degeneration
Wet-AMD is a medical condition which usually affects older adults and generally results in a loss of vision. AMD occurs in "dry" and "wet" 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, 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) (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.
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.