AB Science today announced that its masitinib Phase 2B/3 study (AB12003) in metastatic castrate-resistant prostate cancer (mCRPC) met its predefined primary endpoint

                                                                                                                                                                                                             PRESS RELEASE

PHASE 2B/3 STUDY EVALUATING MASITINIB IN IN METASTATIC CASTRATE-RESISTANT PROSTATE CANCER (MCRPC) MET ITS PRIMARY ENDPOINT

Paris, 29 April 2021, 7pm CET

AB Science SA (Euronext - FR0010557264 - AB) today announced that its masitinib Phase 2B/3 study (AB12003) in metastatic castrate-resistant prostate cancer (mCRPC) eligible to chemotherapy met its predefined primary endpoint.

Patents related to study AB12003 results are being filed and detailed results of study AB12003 will be presented during a webcast with Key Opinion Leaders that will be held as soon as patents have been filed.

About study AB12003

Study AB12003 was an international, multicenter, randomized, double blind, placebo-controlled, 2-parallel group, Phase 3 study in metastatic castrate resistant prostate cancer (mCRPC) eligible to chemotherapy. The study aimed to compare the efficacy and safety of masitinib (6.0 mg/kg/day) in combination with docetaxel versus placebo in combination with docetaxel. Docetaxel was combined with prednisone.

The study primary endpoint was progression free survival (PFS).

The target patient population consisted of adult males who had progressed to develop metastatic castrate resistant prostate cancer (mCRPC) after castration treatment (i.e. reduction of available androgen/testosterone/DHT by chemical or surgical means) and were therefore eligible for chemotherapy.

About castrate-resistant prostate cancer (CRPC)

Development of prostate cancer is often driven by male sex hormones called androgens, including testosterone. Castrate-resistant prostate cancer (CRPC) is defined by disease progression despite androgen depletion (hormone) therapy and may present as either a continuous rise in serum prostate-specific antigen (PSA) levels, the progression of pre-existing disease, and/or the appearance of new metastases. Metastatic CRPC (mCRPC) occurs when the cancer spreads to other parts of the body.