Phase 2 study of obatoclax for treatment of small cell lung cancer (SCLC)

Gemin X Pharmaceuticals announced the completion of patient enrollment in a Phase 2 clinical trial of obatoclax (GX15-070) for the treatment of extensive-stage small cell lung cancer (SCLC).  In this multi-center, randomized, controlled study, the clinical effect of a combination of carboplatin, etoposide and obatoclax (the “CEO” regimen) is being compared to a standard chemotherapeutic regimen of carboplatin and etoposide alone (the control arm). The primary endpoint of the study is comparison of overall response rate (ORR) for the CEO arm versus the control arm, based on RECIST criteria. Secondary endpoints include comparison of six-month rate of progression free survival (PFS) as well as overall PFS. Patients will also be followed for overall survival (OS), and safety. Gemin X anticipates announcing preliminary data results from this Phase 2 trial during the second quarter of 2010.

Obatoclax is a potential first-in-class small molecule antagonist of Bcl-2 designed to inhibit all relevant members of the Bcl-2 family of proteins, including the dominant member, Mcl-1. Inhibition of Mcl-1 and other Bcl-2 related proteins enhances cancer cell death by facilitating apoptotic and/or autophagic cell death. These proteins have been shown to have a pro-survival effect in malignant cells; thus their inhibition by obatoclax could result in the drug’s tumor killing effect. Obatoclax has been shown to activate cancer cell death in vitro, to exhibit anti-tumor activity in animal models, and to enhance the effects of chemotherapy in various models including with the drugs carboplatin and etoposide.

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