Gemin X Completes Patient Enrollment in Phase 2 Clinical Study of Obatoclax for First-Line Treatment of Small Cell Lung CancerCompany Remains On Track for Initial Results in 2Q 2010; Also Announces Corporate Update Presentation at 17th Annual Future Leaders in Biotech Conference on April 8
MALVERN, PA and MONTRÉAL, QC – March 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.
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 17th 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.
Obatoclax, Gemin X’s potential first-in-class small molecule antagonist of Bcl-2, is specifically 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. It has also shown single-agent biological and clinical activity in Phase 1 studies in a variety of cancer indications. Further, obatoclax has demonstrated an early ability to mechanistically evade the resistance built up by cancer cells to traditional chemotherapeutic agents.
Gemin X’s global development plan for obatoclax is focused on diseases marked by a dependence on Mcl-1 for cell survival, including small cell lung cancer (in combination with carboplatin and etoposide), lymphomas, CLL and multiple myeloma.
AboutSmall Cell Lung Cancer
Small cell is an aggressive form of lung cancer, and accounts for about 15% of all lung cancer cases, according to the American Cancer Society. Chemotherapy alone or combined with radiation is the usual treatment of choice for small cell lung cancer. According to the Journal of Clinical Oncology, the median survival time is approximately nine to 10 months with currently available therapies and the five-year survival rate for patients with extensive stage SCLC is less than 1percent. Improved diagnostic and surgical techniques and novel combination therapies that can further extend patient survival are desperately needed to positively impact these outcomes.
About Gemin X Pharmaceuticals
Gemin X is developing first-in-class cancer therapeutics based on reinitiating programmed cell death, or apoptosis, inducing cancer cell self-digestion, or autophagy, and the inhibition of metabolism in cancerous cells. Gemin X currently has several clinical development programs underway, including Phase 2 clinical trials for its lead product candidates obatoclax (GX15-070), an innovative pan Bcl-2 inhibitor, and GMX1777, a novel inhibitor of NAD+ synthesis, and preclinical studies for its Telomere Capping and SMAC Mimetic programs. Potential treatment indications for the full scope of pipeline programs span a broad range of hematological and solid tumors, including chronic lymphocytic leukemia (CLL), melanoma, small cell lung cancer (SCLC), refractory acute lymphoblastic leukemia (ALL) and systemic mastocytosis. Founded in 1998, Gemin X is privately held with drug development and executive headquarters in Malvern, Pennsylvania and drug discovery operations in Montréal, Canada.