S*BIO initiates SB939 Phase 2 clinical trial for metastatic prostate cancer

S*BIO Pte Ltd today announced the initiation of a Phase 2 clinical trial of SB939, its novel orally-active HDAC inhibitor, in patients with recurrent or metastatic prostate cancer (HRPC).

The trial is sponsored by the NCIC Clinical Trials Group and will be conducted at eight clinical sites in Canada.  Sixty milligrams of SB939 will be administered orally three times per week, on alternate days, for three consecutive weeks followed by one week off drug.  The study's primary objective is to determine the compound's efficacy, which will be measured by the prostate-specific antigen (PSA) responses and progression free survival, in HRPC patients who received up to one prior chemotherapy regimen. Secondary objectives include the determination of objective response, the response duration in patients with measurable disease at baseline, and the tolerability and toxicity of SB939 in the study's patient population as well as investigation of biomarkers in circulating tumour cells.

"Advancing into Phase 2 clinical studies with our HDAC inhibitor is a key milestone for S*BIO," said Dr. Jan-Anders Karlsson, CEO of S*BIO. "There is a significant unmet medical need for a viable treatment of HRPC and entering into Phase 2 trials with SB939 shows our full commitment in providing patients and physicians with an effective and safe option to treat this disease."

SB939 is designed to be a "best-in-class" HDAC inhibitor, and has demonstrated the potential to bring additional therapeutic benefits due to its high potency, superior oral availability and good tolerability. In the second half of 2010, S*BIO anticipates that recruitment will commence for another Phase 2 clinical trial with SB939 in patients with translocation-associated sarcomas. This study will also be conducted in collaboration with the NCIC Clinical Trials Group.  In cellular and preclinical models, HDAC inhibitors have been shown to inhibit synovial sarcoma growth. SB939's favourable side effect profile makes it an excellent candidate to address the urgent medical need for new therapeutic options for the treatment of this condition.

SOURCE S*BIO