The placebo-controlled trial will enroll up to 48 healthy male subjects to receive an escalating single intravenous dose of the drug. The trial is being conducted in Munich, Germany with clinical trial material manufactured in the company’s GMP pilot facility.
It is expected that the phase I trial will be completed and the results analyzed by year-end 2005. If the trial results demonstrate that an adequate dose is safe and well-tolerated, phase II trials in pain indications are planned for early 2006.
Contingent clinical protocols are being developed for several potential phase II trials including neuropathic pain, post-surgical pain and other indications. The final decisions regarding indications to be examined in the phase II program will await analysis of the phase I data.
“We hope that Cannabinor will become an anti-pain drug that addresses significant unmet patient needs,” said Dr Haim Aviv, chairman and CEO of the company. “We believe this class of compounds has great promise for a variety of applications in human health as CB1 and CB2 cannabinoid receptors in the brain and immune system play an integral role in nociception, inflammation and autoimmunity.”
In preclinical studies, Cannabinor has been shown to be effective in numerous experiments involving more than a dozen different animal models of various types of pain and autoimmune diseases.