SOURCE: Ohr Pharmaceutical Inc.

December 08, 2009 08:30 ET

Ohr Pharmaceutical Presents New Interim Phase 2 Clinical Data Showing Its OHR/AVR118 Drug to Be Safe, Effective Treatment of Severe Wasting Disorder (Cachexia) in Late Stage Cancer Patients

Selectively Inhibits Inflammatory Immune Response

DOVER, DE--(Marketwire - December 8, 2009) - Ohr Pharmaceutical Inc. (OTCBB: OHRP) announced today that interim data from the Company's Phase 2 clinical trial of OHR/AVR118 demonstrate that the drug safely and effectively restores strength and vitality to patients suffering with Cachexia, a severe wasting disorder that affects late stage cancer patients and others with serious debilitating diseases. The clinical data that were presented yesterday at the 5th annual meeting of the Society of Cachexia and Wasting Disorders in Barcelona are consistent with previous positive clinical trials of OHR/AVR118 in late-stage AIDS patients.

According to Cancer Research UK, a leading independent organization in the United Kingdom dedicated to cancer research, up to six out of 10 patients with advanced cancer develop some degree of Cachexia. Various pharmaceutical industry sources have estimated that the growing commercial market for treating Cachexia is approximately $500 million annually in the U.S. alone. Industry sources have also estimated that the worldwide market for treating Cachexia is approximately $1 billion.

Most of the patients treated in the trial quickly witnessed their weights stabilize, their blood counts rise and their appetites return; these are all very positive responses in cancer patients at very late stages in their battles against the disease. Stronger, more stable patients have a much better chance of tolerating the intense chemotherapies and radiation therapies involved in treating late stages of cancer, said Martin Chasen, M.D., the lead investigator in the trial conducted by the Cancer Nutrition Rehabilitation Program at McGill University Health Centre in Montreal. Dr. Chasen recently moved to head up a palliative rehabilitation and survivorship program at the Elisabeth Bruyere and the Ottawa University hospital. This clinic will allow earlier access in their disease trajectory to patients with cancer to supportive therapies such as OHR/AVR118.

While the patient sample was small, the results added to existing evidence that OHR/AVR118 can effectively counteract the debilitating and cachexia inducing effects of cancers and chemotherapy. The drug's main action is anti-inflammatory through the inhibition and modulation of cellular pro-inflammatory chemokine and cykotine synthesis, including tumor necrosis factor-alpha (TNF-alpha). During the past decade, researchers have adduced much evidence supporting the critical roles of cytokines in the production of Cachexia. Moreover, previous clinical data already indicated that OHR/AVR118, in addition, has powerful chemoprotective effects, allowing patients to tolerate higher doses, and more intensive treatment regimens, with ordinarily toxic chemotherapeutic agents.

The results of the trial offer hope that OHR/AVR118 can provide similar improvements in patients in earlier stages of cancer, Dr. Chasen added.

"I believe this is an exciting drug which targets the inflammatory component of Cachexia," Dr. Chasen said. "OHR/AVR118 needs to also be investigated further in patients during earlier phases of their disease trajectory."

The trial's patients received 4.0 ml of OHR/AVR118 by subcutaneous daily injections. Patients underwent bi-monthly evaluations during the 28-day initial treatment (phase A). Evaluations included Karnofsky performance status, Edmonton Symptoms Assessment Scale (ESAS), Patient Generated Subjective Global Assessment (PG-SGA), Simmonds Functional Assessment (SFA), Dyspepsia Symptom Severity Index (DSSI), weight, lean body mass, skin fold thickness and grip strength. Patients who benefited from phase A could elect to continue with therapy (phase B).

A total of 11 patients completed phase A. Eight patients choose to continue with OHR/AVR118 treatment (phase B). Weight stabilization or gain was observed in 7 of 11 patients. Total PG-SGA scores improved significantly (p = < 0.01). Appetite (p = < 0.01) and depression (p = 0.05) scores improved on ESAS. Frequent burping / belching (p = 0.02), feeling full (p = 0.04) and stomach distention (p = 0.03) improved on the DSSI. Furthermore the SFA tests showed improvement on time to sit and stand (p = 0.01) representing a most important clinical enhancement of the patents' functional capacities. OHR/AVR118 was well tolerated with no serious side effects reported.

"We believe these are dramatic results for very sick patients who are in very late stages in their fight against cancer," said Andrew Limpert, Interim CEO, of Ohr Pharmaceutical. "This data provides further evidence that the mechanism of OHR/AVR118 is very strong and very safe."

Shalom Z. Hirschman, M.D., Chief Science Advisor of Ohr Pharmaceutical, said, "The very positive phase 2 results, heretofore, in extremely ill cachectic cancer patients validate previous clinical trials in cachectic AIDS patients and the very positive clinical effects observed in sporadically treated cancer patients. I very much look forward to a defining phase 3 trial needed to substantiate these exciting therapeutic data."

Dr. Hirschman estimates that Ohr will complete the Phase 2 clinical trial and report the data by the fall of 2010. It then will request approval from the U.S. Food and Drug Administration to commence a definitive Phase 3 randomized, blinded clinical trial.

About Ohr Pharmaceutical Inc.

Ohr Pharmaceutical Inc. ( (OTCBB: OHRP) is a biotechnology company dedicated to the development of first in class drugs for underserved therapeutic needs. Currently, Ohr is focused on the development of two drugs from its pipeline of candidate therapeutics, OHR/AVR118 for the treatment of Cachexia and EVIZON™ for the treatment of wet-AMD.

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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 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. 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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