PHARMOS ANNOUNCES DATA ON INTRAVENOUS CANNABINOR

Pharmos announced preliminary results from its Phase IIa study evaluating intravenous cannabinor, a CB2-selective synthetic cannabinoid compound, in a capsaicin-induced pain model. The drug candidate did not meet the primary endpoint defined by analgesic effects compared with placebo, but the trial confirmed safety and tolerability observed in previous studies. All subjects completed the treatment with no serious adverse events or significant cardiovascular effects.

The randomized, double-blinded, two-way-crossover study enrolled 24 healthy male volunteers to compare 48 mg of cannabinor delivered intravenously versus placebo on capsaicin-evoked allodynia and hyperalgesia.

"While we are disappointed that cannabinor did not show efficacy in this pain model, we have a newly developed oral formulation of cannabinor targeting chronic neuropathic pain with repeated administration," Haim Aviv, chairman and CEO of Pharmos, said. "We plan to move forward with the program for orally administered cannabinor, and our next step is to conduct a Phase I safety trial in healthy volunteers." The company recently completed preclinical toxicology and safety pharmacology studies of oral cannabinor.

Cannabinor has demonstrated efficacy in a number of preclinical animal models of pain, inflammation and autoimmune disease. Analgesic activity has been documented in nociceptive, neuropathic, visceral and inflammatory pain in rodents and in postoperative pain in a porcine surgery model. The magnitude of analgesia was generally equivalent or greater than that of accepted comparator agents, including morphine, non-steroidal anti-inflammatory drugs and Gabapentin, according to the company.