May 28 2010
Relevare Pharmaceuticals Ltd. will present its recent Phase IIa proof-of-concept clinical trial data and extension study results for CNSB015 (flupirtine), its lead repositioned compound, at the Third International Congress on Neuropathic Pain on May 27 –30 in Athens, Greece.
Dr. Kate Cherry, MD, PhD, Head of the Neuropathy and Drug Toxicity Group at the Burnet Institute in Melbourne, Australia will share the results of the Company's Phase IIa trial, entitled, "Flupirtine as an adjunct to opioid analgesia in HIV neuropathy pain" during the Conference's Poster Session on Friday, May 28, 2010.
The results of the recently completed 12-month open-label extension study to be presented by Dr Cherry provide further evidence of the safety and efficacy of flupirtine. In particular, the data indicate clinically relevant improvements for the patients involved in the study in terms of both pain relief and quality of life (mean reductions in BPI Pain Severity and Pain Interference Indices of approximately 30%) when flupirtine is given as an adjunct to opioids.
Flupirtine is orally administered, and used in combination with opioids for the treatment of neuropathic pain. It works by opening potassium channels in the spinal cord and reducing responsiveness and sensitivity to pain signals. Flupirtine may also prevent and/or reverse the development of tolerance to opioid drugs, delivering long-term efficacy of flupirtine/opioid combination therapies without the need to increase dosage.
Mark Blumling, Managing Director of Relevare Pharmaceuticals said: "Flupirtine has been used safely as an analgesic in Germany for over 20 years, and we are pleased with the results of this extension study, which focused on the hard to treat area of painful HIV neuropathy."
The Alfred Hospital has guaranteed funding for the ongoing supply of flupirtine for all patients who completed the open-label study, under the TGA Special Access Scheme. Patients who completed the open-label study at St Vincent's Hospital are also continuing treatment with flupirtine via the Alfred Hospital.
"There is significant is demand for new treatment options among patients with neuropathic pain resulting from conditions such as HIV, cancer and diabetes. We look forward to commencing a 300 patient phase IIb/III trial later this year with patients in Europe and Australia who suffer from opioid resistant cancer pain," he said.
SOURCE Relevare Pharmaceuticals Ltd.