NEW YORK, Dec. 27, 2012 /PRNewswire/ -- Ohr Pharmaceutical Inc., a pharmaceutical company dedicated to the clinical development of new drugs for underserved therapeutic needs in large and growing markets, announced today that it has published a letter to shareholders, available on the Company's website, from its Chief Executive officer, Dr. Irach B. Taraporewala, Ph.D. The letter states:
I would like to take this opportunity to share the progress we have made in 2012 and lay out the milestones we aim to achieve in 2013:
- Initiated Phase 2 clinical trial with Squalamine Eye Drops for the treatment of wet-AMD: The Phase 2 trial (OHR-002) will 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 is enrolling patients at large ophthalmology treatment centers across the United States. Interim results are expected in the fourth quarter of 2013. We believe 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.
- Strengthened balance sheet: The Company completed a $2.9 million dollar financing with a group of existing shareholders at favorable terms. We are now well financed to continue the clinical development of our pipeline compounds.
- Squalamine eye drop data: We completed several preclinical studies to support our Phase 2 clinical trial for the treatment of wet-AMD. The studies demonstrated:
- Therapeutically relevant concentrations in the tissues of the back of the eye
- The ability to maintain those concentrations consistently
- Ocular and systemic safety when administered over a long period of time
Data was presented at the Association for Research in Vision and Ophthalmology (ARVO) conference in May. Dr. Michael Elman, a member of our scientific advisory board, also made an oral presentation, at the Macula Society 2012 meeting, which outlined the clinical relevance of Squalamine eye drops and its potential utility in neovascular ophthalmic disorders.
- FDA Fast Track designation: In May, the U.S. FDA granted our Squalamine eye drop program with Fast Track designation for the treatment of wet-AMD. Fast track designation is awarded to programs that meet specific criteria which includes programs that demonstrate the potential to treat an unmet medical need. Fast track status will provide us with many advantages to potentially accelerate development of the Squalamine eye drop program, such as more frequent meetings with the FDA and the potential for Priority Review.
- Formation of World Class Scientific Advisory Board: We assembled an ophthalmic scientific advisory board consisting of seven top thought leaders in the treatment of retinal disorders and other ophthalmology indications. These thought leaders have been actively involved in the clinical development of therapeutics approved by the FDA for wet-AMD (Lucentis ® and Eylea®), and are at the leading edge of research into novel therapeutics for retinal disorders.
- Strengthening of patent portfolio: In 2012, we were granted several key patents on our Squalamine and OHR/AVR118 programs including composition of matter and method of use claims. Additional applications have been filed and we plan to continue expanding our intellectual property portfolio.
- Increased market awareness and visibility: During 2012, we amplified our efforts to increase market awareness and visibility of our exciting story through road show meetings with institutional investors, presentations at investor conferences, online and print articles, and social media. Of particular note, are the recent research coverage initiations from two Wall Street firms, Burrill & Company and Brean Capital. This increased investor awareness coupled with continued business execution has resulted in a tremendous increase in shareholder value in 2012.
Anticipated 2013 Milestones
- Completion of OHR/AVR118 Trial and Data Presentation: Enrollment of the OHR/AVR118 trial is complete and we will present top line data from the phase II trial in the first quarter of 2013. The interim analysis from the current trial demonstrated positive effects and mitigation of multiple symptoms of cachexia, including increase in appetite. Cachexia is a severe wasting disorder often seen in late stage cancer patients which is highly debilitating and diminishes their quality of life. There is currently no FDA approved therapy for cancer cachexia.
- Interim Data from Squalamine Eye Drops Phase 2 Trial: The OHR-002 study to evaluate the efficacy and safety of Squalamine eye drop for the treatment of wet-AMD patients continues to enroll patients. The protocol includes a predetermined interim analysis when 50% of the patients have completed the nine month treatment period, and we expect to have those results in the fourth quarter of 2013.
- Uplisting to a national exchange: Based on our strengthened financial position, we are planning on moving our listing to a larger national exchange and expect to do so by the end of the second quarter.
- Progress of additional indications and pipeline molecules: In 2013, we expect to present additional data from a completed phase IIa study of Squalamine in resistant ovarian cancer, an Orphan Drug indication, and continue to progress with Trodusquemine and related compounds currently undergoing preclinical testing in a yet undisclosed indication.
Our programs have the ability to meet large unmet medical needs in large and growing, well established markets. Wet-AMD in particular, is an area that has received a lot of attention lately with the successful launch of Regeneron's (REGN) Eylea® and the continued commercial success of Roche/Genentech's (RHHBY) Lucentis®, which are likely to have worldwide revenues for 2012 in excess of $4 billion.
I thank you for your ongoing support and I look forward to updating you in the future as we continue to progress with our exciting development programs.
Irach B. Taraporewala
Chief Executive Officer
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 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.
Tel: (877) 215-4813
SOURCE Ohr Pharmaceutical Inc.