Ohr Pharmaceutical Enrolls First Three Patients at a new Clinical Site for Ongoing Phase 2b Cachexia Trial
News Dec 15, 2010
Ohr Pharmaceutical Inc. has 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."
In the largest study of its kind, researchers at Newcastle University have led national research into the treatment of patients with newly diagnosed myeloma. The results, published by The Lancet Oncology, show an improvement for those who received ongoing therapy with a drug called lenalidomide, compared to those not receiving it.READ MORE
The cholesterol-lowering drugs called statins have demonstrated substantial benefits in reducing the risk of heart attacks and strokes caused by blood clots (ischemic strokes) in at-risk patients. Since statins are associated with a low risk of side effects, the benefits of taking them outweigh the risks, according to a scientific statement from the American Heart Association that reviewed multiple studies evaluating the safety and potential side effects of these drugs.READ MORE