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March 21, 2013 /PRNewswire/ -- Ohr Pharmaceutical (OTCQB: OHRP), a pharmaceutical company focused on the development of novel therapeutics for large unmet medical needs, today announced the results of a Phase II trial to evaluate the effects of OHR/AVR118 in advanced cancer patients with cachexia. Cancer cachexia is the complex, multi-symptom syndrome seen in late-stage cancer patients, characterized by anorexia and unintended loss of appetite, progressive and continual weight loss, accompanied by generalized host tissue wasting, skeletal muscle atrophy, immune and metabolic dysfunction, and a greatly diminished quality of life. Cancer cachexia is most pronounced in advanced malignancies such as lung, pancreatic and gastrointestinal cancers. There is currently no FDA approved therapy for cancer cachexia.
Eighteen enrolled patients, three with stage III and fifteen with stage IV cancers completed the treatment protocol. The group consisted of six with pancreatic cancer, five with lung cancer, two with prostate cancer and one each with colon, stomach, esophageal, liver cancers and multiple myeloma. While the primary trial end point of weight gain was not achieved, at the completion of treatment, patients achieved stabilization of body weight, body fat and muscle mass with a significant increase in appetite (p=.001). Moreover, PG-SGA (Patient Generated Subjective Global Assessment) scores demonstrated improvement (p=.025), indicating an enhanced quality of life (QOL). No statistically significant differences from baseline (as indicated by the paired
t test) were observed in body fat content, arm circumference, triceps fold measurement, nausea or vomiting.
Patients had the option to continue receiving study drug after completing the initial 28 day treatment period if they and their doctor felt it was in their best interest, and 11 of the 18 patients (61%) elected to do so, being treated with the drug for a total of between 42 to 153 days. Sustained body weight stabilization was maintained even on prolonged therapy with the drug in this sub-group of patients. Importantly, these results were seen despite the fact that 7 of the 18 patients were receiving concomitant chemotherapy, and 1 was receiving concomitant radiotherapy during the trial treatment period with OHR/AVR118. Ordinarily, chemotherapy and radiation exacerbate the symptoms of cachexia. The drug was well tolerated by the patients in the study. The Company expects to present additional detailed data in a presentation at an appropriate scientific forum or in a peer reviewed publication.