6:01AM Ohr Pharma presents Phase II data on OHR/AVR118 in advanced cancer patients with Cachexia Presented (OHRP) 8.15 : Co announces that full results from a Phase II trial to evaluate the effects of OHR/AVR118 in advanced cancer patients with cachexia were presented yesterday at the 7th International Cachexia Conference in Kobe, Japan. The data were selected for podium presentation of late breaking clinical trials and were presented by principal investigator Dr. Martin Chasen, Medical Director, Palliative Care, Ottawa Hospital Cancer Centre, Canada.
In this Phase 2 trial with OHR/AVR118, 29 patients with advanced cancer and cachexia were enrolled. 18 patients, 3 with stage III and 15 with stage IV cancers completed the treatment protocol. This included 5 patients with pancreatic cancer, 5 with lung cancer, 2 with prostate cancer and one each with colon, stomach, esophageal, liver cancers, head and neck cancer and multiple myeloma. While the primary trial end point of weight gain was not met, at the completion of treatment, patients achieved stabilization of body weight, body fat and muscle mass with a significant increase in appetite. Moreover, there was an improvement in PG-SGA scores, indicating an enhanced quality of life. 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.
After completing the initial 28 day treatment period, patients had the option to continue receiving study drug if they felt it was in their best interest. Eleven 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. 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. Chemotherapy and radiation frequently exacerbate the symptoms of cachexia. Overall, the drug appeared well tolerated with minimal side effects.
