This excerpt taken from the AEN 8-K filed Aug 14, 2008.
TRIMESTA (oral, once-daily estriol)
TRIMESTA, our oral, once-daily bioidentical hormone estriol is currently in a seven U.S. center, placebo-controlled Phase II/III clinical trial which is expected to enroll up to 150 relapsing-remitting Multiple Sclerosis (MS) patients. TRIMESTA is being supported under a $5 million grant from the Southern California Chapter of the National Multiple Sclerosis Society and NIH. Oral estriol, the active ingredient in TRIMESTA, has been approved throughout Europe and Asia for approximately 40 years but is not available in the U.S.
This Phase II/III clinical trial builds upon our encouraging results from an earlier single agent Phase IIa clinical trial in female MS patients whereby TRIMESTA demonstrated a 79 percent decrease in MS brain lesions in 3 months (p=0.02) and a 14 percent improvement in cognitive function as measured by the PASAT scoring system at 6 months (p=0.04). This dataset is also supplemented by a definitive study of the effect of pregnancy on MS, known as the PRIMS (Rate of Pregnancy-related Relapse in Multiple Sclerosis) which was published in the New England Journal of Medicine (NEJM) by Confavreux et al. In that study, relapse rates were determined in 254 women with MS during pregnancy and for up to one year after delivery. Relapse rates were shown to be significantly reduced during the third trimester of pregnancy, by 71 percent (p