Cortex Pharma enters into license agreement with University of Illinois

Cortex is developing dronabinol (D9-tetrahydrocannabinol), a cannabinoid, for the treatment of obstructive sleep apnea (OSA), the most common form of sleep apnea.

Cortex previously conducted a 21 day, randomized, double-blind, placebo-controlled, dose escalation Phase 2 clinical study in 22 patients with OSA, in which dronabinol produced a statistically significant reduction in the Apnea-Hypopnea Index (AHI), the primary therapeutic end-point, and was observed to be safe and well tolerated.

Dronabinol is currently under investigation, at the University of Illinois and other centers, in a pivotal Phase 2 OSA clinical trial, fully funded by the National Institutes of Health.

Dronabinol is a Schedule III, controlled generic drug with a relatively low abuse potential that is approved by the FDA for the treatment of AIDS related anorexia and chemotherapy induced emesis. The use of dronabinol for the treatment of OSA is a novel indication for an already approved drug and, as such, would only require approval by the FDA of a supplemental new drug application (sNDA).

"I am delighted that we have been able to re-establish our relationship with the University of Illinois, a leading center for sleep-related breathing disorders," said Dr. Arnold Lippa, the Chairman and Chief Executive Officer of Cortex.

"This new license agreement allows us to continue our development of dronabinol with confidence that our work will be protected by the patents that are the subject of this agreement. Furthermore, by substantially strengthening our cannabinoid platform, this agreement also provides impetus for the regeneration of Cortex and the continuing development of Cortex’s revised business plan under its new management team."