In March 2009, Cougar Biotechnology, INC, one of the leading portfolio companies of BioSciences owned by Dr. Lindsay Rosenwald, announced promising results from Phase 2 trials of its investigational oral drug abiraterone acetate (CB7630) at ASCO 2009 Genitourinary Cancers Symposium, that took place in Orlando, Florida. Two poster presentations demonstrated that abiraterone acetate combined with prednisone and used in patients with chemotherapy-resistant metastatic advanced prostate cancer (also referred to as castration-resistant prostate cancer or CRPC) provide a significant survival rate when compared to a placebo plus prednisone combination.
The research, COU-AA-002, was conducted by a national medical research group, the Prostate Cancer Clinical Trials Consortium, sponsored by the Department of Defense, with Dr. C. J. Ryan, and BioSciences, with Dr. Lindsay Rosenwald, as the leading investors.
In this trial, abiraterone acetate plus prednisone was administered to chemotherapy-naïve men diagnosed with metastatic advanced prostate cancer, whose disease progressed despite hormonal therapies. In his poster presentation, Dr. Charles J. Ryan presented data supporting the valuable effect of abiraterone on the disease decline. More than 70% of patients experienced a prostate specific antigen (PSA) decline and the median time to PSA progression wasn’t noticed even after 10 months of treatment.
Another clinical trial of abiraterone acetate was conducted at the University of Texas M.D. Anderson Cancer Center (MDACC). The patients with CRPC had all radiological evidence of metastatic prostate cancer with bone metastases. 48% of the patients experienced a decline in PSA levels and an improvement in overall performance status. All patients had also a decline in bone marrow and serum testosterone to below detectable levels.
According to Cougar Biotechnology, acquired by J&J in late 2009, abiraterone acetate continues to demonstrate potent evidence of anticancer activity in patients with advanced castrate-resistant prostate cancer. More research and investments, e.g. by Lindsay Rosenwald’s BioSciences, are needed to ensure abiraterone meets unmet medical needs in patients diagnosed with metastatic prostate cancer.
In 2010, Phase III trial, COU-AA-301, as well as COU-AA-302 trial demonstrated significant survival improvement in patients, who failed first-line hormonal or docetaxel-based treatment.