Enrollment complete in Gemin X Pharmaceuticals' Phase 2 clinical trial of obatoclax for SCLC

Mar 29 2010

Gemin X Pharmaceuticals, a clinical stage biopharmaceutical company developing novel, targeted cancer therapeutics, today announced the completion of patient enrollment in a Phase 2 clinical trial of the Company's lead product candidate obatoclax (GX15-070) for the treatment of extensive-stage small cell lung cancer (SCLC). The trial is designed to evaluate the efficacy and safety of obatoclax, a novel pan Bcl-2 inhibitor, in combination with standard chemotherapy for the first-line treatment of patients with SCLC. It is being conducted at over 60 leading cancer centers, primarily in the United States and Europe. Full trial enrollment of 165 SCLC patients was achieved ahead of schedule and exceeded the study goal of 154 participants. Gemin X anticipates announcing preliminary data results from this Phase 2 trial during the second quarter of 2010.

“A novel approach and differentiated mechanism of action, as demonstrated to-date by obatoclax, could offer these patients the possibility of substantial improvements in response to treatment, tolerability and survival.”

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.

"We are very pleased to have reached this milestone in our Phase 2 SCLC study for obatoclax. We look forward to the trial results and to evaluating the activity of the obatoclax combination arm against standard chemotherapy. Based on the synergies observed between obatoclax and carboplatin and etoposide in preclinical studies, and by the safety profile and high response rates witnessed in the vast majority of SCLC patients in our earlier Phase 1b trial, we are hopeful about the potential of obatoclax to become an important therapeutic for these cancer patients," commented Jean Viallet, M.D., Executive Vice President and Chief Medical Officer for Gemin X. "A novel approach and differentiated mechanism of action, as demonstrated to-date by obatoclax, could offer these patients the possibility of substantial improvements in response to treatment, tolerability and survival."

Study participants in the obatoclax combination arm of this Phase 2 trial each receive a three-hour infusion over three consecutive days of dosing, repeated every three weeks over six treatment cycles (provided there is no evidence of disease progression or intolerability). Patients enrolled into this arm, who have not progressed after six treatment cycles, continue to receive obatoclax alone as maintenance therapy.

Gemin X also announced today that the company has been selected to present a corporate overview and clinical development strategy update at the 17^th Annual Future Leaders in the Biotech Industry Conference at the Millennium Broadway Hotel and Conference Center in New York City. Gemin X's presentation is scheduled for 11 a.m. ET on April 8, 2010.