SOURCE: Ohr Pharmaceutical Inc.

Ohr Pharmaceutical Inc.

December 14, 2010 08:30 ET

Ohr Pharmaceutical Enrolls First Three Patients at a New Clinical Site for Ongoing Phase 2b Cachexia Trial

NEW YORK, NY--(Marketwire - December 14, 2010) - Ohr Pharmaceutical Inc. (OTCBB: OHRP) today announced the enrollment of the first three patients at a new clinical site in its ongoing Phase 2b clinical trial to investigate the efficacy of OHR/AVR118 for the treatment of cancer cachexia in patients with recurrent or advanced cancers. The ongoing trial will evaluate the response to daily treatments of OHR/AVR118 on appetite, weight, lean body mass (LBM), strength, depression, and quality of life parameters as well as the safety profile. The trial protocol calls for a total of 30 patients to be enrolled, 11 of which have already been completed.

Cachexia is a severe wasting disorder often seen in late stage cancer patients whereby the patient exhibits multiple symptoms including loss of muscle and fat, anorexia, fatigue, loss of appetite, weakness, and multiple gastrointestinal symptoms. 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. Additionally, upwards of 20% of cancer fatalities can be attributed to the effects 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. There is currently no FDA or Health Canada approved therapy for cancer cachexia.

"OHR/AVR118 is currently at the forefront of clinical development for cancer cachexia. We are very encouraged by our progress towards bringing OHR/AVR118 to commercialization and addressing this large unmet medical need," said Dr. Irach B. Taraporewala, Ph.D., CEO of Ohr Pharmaceutical. "It is exciting to be working with The Ottawa Hospital Cancer Centre, a leading regional cancer center for the Ontario province. Their professionalism and dedication to the treatment of their patients is truly first class."

Dr. Martin Chasen, principal investigator of the trial, added, "OHR/AVR118 has the potential to greatly benefit advanced cancer patients suffering from the debilitating effects of cachexia. Stronger, more stable patients have a much better chance of tolerating the intense chemotherapies and radiation therapies involved in treating late stages of cancer."

OHR/AVR118 is a broad spectrum immunomodulator whose main action is to act as an anti-inflammatory through the inhibition and modulation of cellular pro-inflammatory chemokine and cykotine synthesis, including tumor necrosis factor-alpha (TNF-alpha) and interleukin-6 (IL-6). During the past decade, researchers have adduced much evidence supporting the critical roles of cytokines in the production of cachexia. Moreover, previous clinical data indicates that OHR/AVR118, in addition, has powerful chemoprotective effects, thus allowing patients to tolerate higher doses, and more intensive treatment regimens, with toxic chemotherapeutic agents. OHR/AVR118 is novel in that it addresses the underlying etiology of the cachexia disease process, as opposed to current and investigational therapies being used for cancer cachexia, that attempt to mitigate just one or two symptoms of cachexia.

Interim Data:
Interim data from this Phase 2b trial was presented at the 5th annual meeting of the Society of Cachexia and Wasting Disorders in Barcelona, and were consistent with previous positive clinical trial results of OHR/AVR118 in late-stage cachectic AIDS patients.

A total of 11 patients completed the treatment period, with 8 (73%) of those patients electing to continue with OHR/AVR118 treatment beyond the treatment period. 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. 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.

About Ohr Pharmaceutical Inc.:
Ohr Pharmaceutical Inc. (OTCBB: OHRP) is focused on the development of two drugs: OHR/AVR 118 for the treatment of cancer cachexia and EVIZON™/Squalamine for the treatment of the wet form of age-related macular degeneration (Wet-AMD). Cancer cachexia, the syndrome of body wasting that affects late-stage cancer patients, is a debilitating condition which adversely affects their quality of life. Wet-AMD is a leading cause of vision loss and blindness in the elderly population. The promise shown by Ohr Pharmaceutical's products pipeline offers a new ray of hope to patients suffering from these devastating diseases.

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.

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