pipeline

The Company has selected as its lead clinical candidates two compounds (SRX251 and SRX246) that selectively and specifically block the V1A receptor.

Phase I clinical studies with SRX251 were completed in Q1 2008, establishing the safety and tolerability of SRX251. Phase 2 studies are planned to be initiated in late 2008 for the treatment of pain associated with primary dysmenorrheal. This indication, defined by pelvic pain and discomfort, also can trigger stress or anxiety. In its most severe form, premenstrual dysphoria/dysmenorrhea, the pelvic pain and discomfort is accompanied by depression. The Company chose this indication to lead its clinical pipeline because 1) it is considered “quick-to-market”-- objective endpoints, well-defined patient populations, relatively short development times, and low development costs, and 2) Sanofi-Synthelabo has shown clinically that V1A antagonism reduces pelvic pain in women with dysmenorrhea. The dsymenorrhea market is estimated to be approximately $4+ billion annually.

The SRX246 IND filing is anticipated in Q3 2008 for the treatment of stress-related affective illness. Pre-clinical and clinical studies with this compound are supported in part by the National Toxicology Evaluation Program, RAID, and SBIR Phase IIa grants through the National Institute of Mental Health (NIMH). In the U.S. alone, anxiety and depression affect over 36 million people and pharmaceutical treatments represent an estimated $20 billion market annually.