Harbor BioSciences, Inc has received a notice of allowance from the United States Patent Office of patent claims covering the use of its lead product candidate Apoptone. The patent claims cover the use of Apoptone to treat prostate cancer, breast cancer and benign prostatic hypertrophy. Apoptone (HE3235) is a novel synthetic steroid analog of a dihydrotestosterone metabolite and has been found to stimulate cell death (apoptosis) in animal models of prostate and breast cancers.

Apoptone is a first-in-class oral compound in a phase-I/IIa clinical trial in late-stage prostate cancer patients who have failed hormone therapy and at least one round of taxane-based chemotherapy treatment. Currently there is no effective treatment for late-stage prostate cancer, the second leading cause of death in men in the United States. Over one million men in the United States have prostate cancer; approximately 90,000 of these patients have late-stage prostate cancer, resulting in approximately 28,000 deaths each year. There are currently no approved treatments for hormone and chemotherapy refractory prostate cancer and the survival time is estimated to be between eight and 12 months.

Harbor BioSciences is a development-stage company with two product candidates in clinical trials: Apoptone (HE3235), in the cohort expansion portion of a phase-I/IIa trial of patients with late-stage prostate cancer, and Triolex, in a phase-IIa trial in obese type-2 diabetes mellitus patients.