Competitive Technologies, Inc. (OTCQX: CTTC) today announced an update regarding Xion Pharmaceuticals ("Xion"), a joint venture with CTTC formed in 2010 to advance the commercialization of Melanotan-II (MT-II) peptides especially for sexual dysfunction.
Dr. Natan Bar-Chama, Director of Male Reproductive Medicine and Surgery and Faculty in the Department of Urology at Mt. Sinai School of Medicine, researchers from New York Medical College and Xion's Dr. Mike Wyllie presented the current status of Xion research and development at the Annual Meeting of the American Urological Association last month. In their presentation at AUA, the team concluded that they had "for the first time demonstrated the ability to deliver the MT-II orally" in animal trials, further concluding that "Melanotan-II (MT-II) a centrally acting synthetic melanocortin analog may in the future provide oral as needed therapy for men with erectile dysfunction." Earlier studies of these peptides showed efficacy and safety when administered subcutaneously (injected) for psychogenic as well as organic erectile dysfunction.
The earlier studies confirmed the pro-erectile activity of MT-II and have shown the mechanism of action is central through the forebrain and spinal cord activation with a distinct positive impact on libido. This clearly differentiates it from the currently available PDE-5 inhibitors such as Viagra, Cialis and Levitra, and indicates potential for the as yet untapped female sexual dysfunction market. The conclusions presented at AUA support the plan to proceed with formulation optimization and initial human studies.
"I'm delighted with the progress our long-term partner Xion has made with the melanocortin portfolio," CTTC's CEO Carl O'Connell stated. "It is this sort of collaboration that makes successful commercialization a reality for most technologies."
Independent third party valuations of this technology conducted in December 2012 indicated a value of between $125 and $230 million. CTTC's share as a 30% owner of Xion Pharmaceuticals would be between $37 and $69 million.
Because the mechanism of action is different from PDE-5 inhibitors currently available for treating ED, the MT-II formulation could be used either synergistically or in refractory cases (i.e., cases in which PDE-5 inhibitors are not effective). The next steps include human trials to build on the already proven subcutaneous delivery by performing additional studies using the novel oral MT-II formulation and proceeding with human dosing in a robust Phase I/II program.
About Xion Pharmaceutical Corporation
Xion Pharmaceutical Corporation was founded as a joint venture between Competitive Technologies, Inc., Xion Holding Corporation, and Eden Consulting Group Inc. to further research and develop an oral formulation of a synthetic a-melanocortin stimulating hormone (a-MSH) for commercial distribution as a new pharmaceutical therapy for the robust erectile dysfunction (ED) market, female sexual dysfunction (FSD) and obesity markets, designated as XN-105.
Xion's management team is comprised of individuals who contributed significantly and were instrumental to the successful development, approval and marketing of both Viagra and Cialis. The team offers nearly 50 years of combined pharmaceutical experience and has a successful track record in drug development, testing, and approval.
