Traumatic Brain Injury
BHR Pharma intends to initiate a Phase 3 global multi-center pivotal trial of BHR-100 (i.v. progesterone infusion) in severe TBI patients in late 2009, with the collaboration of the American Brain Injury Consortium (ABIC) and the European Brain Injury Consortium (EBIC). Progesterone has been shown to improve TBI outcomes in experimental animal models and to enhance survival and functional outcomes in human TBI patients.
Prostate Cancer
BHR Pharma is developing BHR-200 (transdermal estradiol gel) for the palliative treatment of advanced androgen-sensitive carcinoma of the prostate and for the treatment of the vasomotor side effects in men undergoing androgen deprivation therapy (ADT) for prostate cancer. BHR-200 is a prostate cancer treatment that uses a proprietary transdermal estradiol formulation, prescribed alone or in combination with GnRH agonists.
Breast Pain
BHR Pharma has formulated a topical gel of Afimoxifene (4-hydroxytamoxifen or 4-OHT), one of the most active metabolites of tamoxifen, using Enhanced Hydroalcoholic Gel Technology (EHG™). The gel is directly applied to the breast for transdermal delivery to the breast tissue. In previous clinical trials, Afimoxifene gel has been shown to be biologically active in the breast tissue, while having systemic exposure in the plasma that is nine times lower than that of oral tamoxifen.
Gynecomastia
Afimoxifene (4-OHT) gel will be investigated as a treatment for gynecomastia, the overdevelopment of breast tissue in males, and associated breast pain. Boys or men with gynecomastia experience swelling in the glandular breast tissue due to an excess of estrogen or a lack of testosterone.
Breast Cancer
Afimoxifene (4-OHT) gel has the potential for use in breast cancer prevention as well as a treatment for cyclic breast pain and other benign breast conditions. A multi-center, Phase 2 trial of Afimoxifene gel vs. oral tamoxifen in women with ductal carcinoma in situ (DCIS) of the breast will be conducted by the National Cancer Prevention Group Consortium under the coordination of the National Institutes of Health/National Cancer Institute.