SAN DIEGO, March 6 /PRNewswire/ -- AndroScience Corporation (ASC(TM)), a developmental stage pharmaceutical company announced results of a Phase 2a dose-ranging study of their lead clinical compound for the treatment of acne. The randomized, double-blinded, vehicle-controlled study completed in late 2008 enrolled 186 patients with acne and consisted of twice daily topical applications of ASC-J9(TM) cream for 12 weeks to evaluate safety and ascertain preliminary efficacy.
ASC-J9(TM) demonstrated a clinical benefit in reducing inflammatory lesions compared to placebo at certain dosages and at multiple time points during the study, though the study was not powered for statistical significance. ASC will now focus on bolstering efficacy through a new formulation and intends on forming a co-development or licensing partnership for future clinical development and commercialization. Through enhancing androgen receptor protein degradation, ASC-J9(TM) represents the first topical agent directed at modulating the effect of androgens (male hormones), through the androgen receptor, a key causative factor in the pathogenesis of acne.
Charles Shih, Ph.D., Chief Executive Officer of AndroScience Corporation, said, "We are extremely enthusiastic about the therapeutic potential of ASC-J9(TM) and the remarkable safety profile exhibited by the drug. The 0.025% cream formulation dose of ASC-J9(TM) delivered a therapeutic benefit comparable to levels seen with marketed acne drugs on inflammatory lesions, with no side effects, and we believe a higher dosage or improved formulation will translate to even greater efficacy in the treatment of acne."
ASC-J9(TM) is a small molecule with a novel mechanism of action, which selectively enhances androgen receptor degradation (ARD) to reduce androgen activity. ARD enhancers act on a key cause of acne, the androgen activation system, through reducing high levels of androgen receptor present in the sebaceous gland to lower sebum secretion, a fundamentally different approach from all other current acne treatments. ASC-J9(TM) cream is topically administered and exhibits low systemic absorption, limiting systemic side effect risks and allowing for the treatment of both males and females.
In addition to acne indication, AndroScience is currently pursuing androgenetic alopecia (male pattern baldness), and wound healing using topical based formulations; and prostate cancer, benign prostatic hyperplasia, and spinal bulbar muscular atrophy (Kennedy's Disease - a neuron motor disease caused by AR mutation) utilizing systemic based approaches.
CONTACT: Charles C-Y Shih, Ph.D., of AndroScience Corporation,
Web site: http://www.androscience.com/