October 24, 2008
Key Data Presented for Gemin X Programs at the 20th Annual ENA Symposium
Gemin X Pharmaceuticals announced today key clinical and preclinical data from studies of two of the Company's novel, targeted cancer therapeutics - obatoclax (GX15-070), an innovative pan-Bcl2 inhibitor; and GMX1777, a novel inhibitor of NAD+ metabolism. These data were presented during the 20th EORTC-NCI-AACR (ENA) Symposium on "Molecular Targets and Cancer Therapeutics," being held in Geneva, Switzerland from October 21 through October 24, 2008.
"These multiple poster presentations at ENA underscore the therapeutic promise of both obatoclax and GMX1777," said Glenn J. Gormley, M.D., Ph.D., President and Chief Executive Officer of Gemin X. "These data provide Gemin X with important information that support our clinical development strategies and our active clinical trials for these novel and targeted cancer therapies."Three poster presentations highlighted obatoclax and GMX1777 data findings:
-- GMX1777 Phase 1 - this first-in-man study achieved its goal to identify a dose of GMX1777 for Phase 2 studies. A tolerable safety profile for 24-hour infusions of GMX1777 was confirmed and the maximum tolerated dose (MTD) for this time period was identified. Further, the pharmacokinetic (PK) parameters of GMX1777 were determined. Although response was not the primary endpoint of this trial, single agent GMX1777 showed modest clinical activity with three patients having stable disease for greater than three months.
-- GMX1777 Preclinical Study - these data illustrated the potential for improved cancer treatments using rational drug combinations of the novel targeted agent GMX1777 with established therapies. This poster features Gemin X's testing of a wide spectrum of DNA damaging agents to determine synergies with the active component of GMX1777 (GMX1778) in vitro. This study showed that temozolomide exhibited the greatest synergy in combination with GMX1778 treatment. Gemin X is currently exploring GMX1777 in combination with temozolomide for the treatment of melanoma patients.
-- Obatoclax Phase 1/2 Trial - this trial studied the safety and efficacy of obatoclax in combination with the cytotoxic agent docetaxel, administered as a 48-hour infusion every three weeks, in patients with relapsed or refractory non small cell lung cancer (NSCLC). Obatoclax in combination with docetaxel was well tolerated at the highest dose evaluated, however no obvious improvement in response rate or progression free survival (PFS) was seen compared to docetaxel alone historical controls. Based on the feasibility of combining cytotoxic chemotherapy, Gemin X identified small cell lung cancer (SCLC) as a potentially more appropriate target indication and designed a randomized Phase 1/2 trial in previously untreated SCLC patients. That trial is assessing the safety and efficacy of obatoclax in combination with carboplatin/etoposide (C/E) - a model of established obatoclax synergy - and is currently underway.
"These data presented at ENA offer valuable insights into our obatoclax and GMX1777 programs and are helping Gemin X to shape our clinical development plans and trial designs moving forward," said Jean Viallet, M.D., Chief Medical Officer for Gemin X. "Establishing the safety and PK profile for GMX1777 is key as we determine our dosing regimen for Phase 2 studies. Further, understanding both the single agent and rational drug combination possibilities and opportunities for GMX1777 is invaluable as we advance our program to treat melanoma. Finally, the data from our Phase 1/2 in obatoclax have provided critical learnings that have helped Gemin X build the foundation for our current Phase 1/2 trial in SCLC."
The ENA Symposium is hosted by the European Organization for Research and Treatment of Cancer (EORTC), the National Cancer Institute (NCI) and the American Association for Cancer Research (AACR). It is organized to bring together academics and scientists and representatives from the pharmaceutical industry to discuss innovation in drug development, target selection and the impact of new discoveries in molecular and cell biology. This conference highlights many recent advances in the early development of promising new compounds at various levels of preclinical and clinical development.
About Gemin X Pharmaceuticals
Gemin X Pharmaceuticals is dedicated to the discovery, development and commercialization of novel, targeted cancer therapeutics to improve the lives of patients. Gemin X is developing first-in-class cancer therapeutics based on reinitiating programmed cell death, or apoptosis, and the inhibition of metabolism in cancerous cells. Gemin X currently has three clinical development programs underway, ranging from 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, to preclinical studies for its Telomere Capping program. Potential treatment indications for the full scope of pipeline programs span a broad range of hematological and solid tumors, including elderly acute myeloid leukemia (AML), mantle cell lymphoma (MCL), melanoma, glioblastoma, small cell lung cancer (SCLC), refractory acute lymphoblastic leukemia (ALL) and mastocytosis. Founded in 1998, Gemin X is privately held with drug development and executive headquarters in Malvern, Pennsylvania and drug discovery operations in Montreal, Canada. For more information, please visit www.geminx.com.