HPT/Axis is developing enclomiphene, an isomeric form of clomiphene, for new clinical indications, in a long neglected disorder with no FDA approved treatment, potential to be first-in-class thus becoming the standard of care treatment, in a large market, and protected by method-of-use patents. For enclomiphene, the immediate business opportunity is the treatment of the adverse psychological changes after stopping anabolic steroids, the condition termed anabolic steroid induced hypogonadism (ASIH).

ASIH occurs 100% of the time after stopping anabolic steroid use, both prescription and nonprescription. The only variables are duration and severity. Upon anabolic steroid cessation, psychological disturbances include aggressiveness, depression, suicide, anxiety, potency problems (libido), sleep disorders, and cognitive impairment. The important point for these changes, measurable QOL parameters, is they allow for an easier path for FDA approval.

Identifying existing FDA approved drugs for new clinical indications substantially bypasses costs and time. In the case of enclomiphene, one of the isomers of clomiphene is a current FDA approved generic drug. This is faster than obtaining approval from FDA for a novel compound and gives a faster time to market. This enables HPT/Axis to be a clinical stage company.

The Federal and State government have taken special notice for the period after AAS cessation, particularly the adverse effects of clinical depression, suicidal ideation, and suicide. These were highlighted in the recent congressional hearing on March 17, 2005 entitled, “Restoring Faith in America’s Pastime: Evaluating Major League Baseball’s Efforts to Eradicate Steroid Use.“ Shortly thereafter Texas HB 3563, “Use Of Anabolic Steroids By Public School Students,” was passed and signed into law June 18, 2005. Of particular importance is the bill analysis citing the problem of “clinical depression when steroid use is stopped.