Review of Clinical Data from Gemin X Biotechnologies' GX15-070 Program Presented at the 24th Annual Chemotherapy Foundation Symposium.MONTREAL -- Gemin X Biotechnologies Inc. announced today that a review of Phase 1 clinical data obtained with the company's lead product candidate, GX15-070, was presented yesterday by Dr. Susan O'Brien, principal investigator and leukemia specialist with The University of Texas M.D. Anderson Cancer Center, during the 24th Annual Chemotherapy Foundation Symposium. Currently in Phase 2 clinical trials, GX15-070 is a small molecule specifically designed to inhibit all relevant members of the Bcl-2 protein family, a validated cancer target, thus restoring the natural cell death process of apoptosis. "In summary, GX15-070 has shown relevant biological and clinical activity as a single-agent in patients with refractory lymphomas and several types of leukemias, with primary side effects being infusion-related somnolence and euphoria, and no significant myelosuppression, immunosuppression, organ damage, or cumulative toxicities," O'Brien said. "It is unusual to see such promising data this early in development of a first-in-class cancer drug, and I look forward to evaluating GX15-070 in Phase 2 trials." The GX15-070 (obatoclax) clinical data were summarized in a presentation entitled, "Obatoclax, A Small Molecule Pan Bcl-2 Family Inhibitor with Activity in Hematologic Malignancies." The summary included data from three Phase 1 clinical trials evaluating GX15-070 as a single-agent in patients with chronic lymphocytic leukemia chronic lymphocytic leukemia n. Abbr. CLL Lymphocytic leukemia occurring mainly in older adults, characterized by slow onset and gradual progression of symptoms. (CLL CLL abbr. chronic lymphocytic leukemia CLL, n.pr See leukemia, chronic lymphocytic. CLL 1. Chronic lymphocytic leukemia 2. Cholesterol-lowering lipid ), refractory solid tumors or lymphomas, myelodysplastic syndromes (MDS MDS, n See temporomandibular pain-dysfunction syndrome. MDS 1 Maternal deprivation syndrome, see there 2 Myelodysplastic syndrome, see there ), or acute myelogenous leukemia acute myelogenous leukemia n. Abbr. AML Myelogenous leukemia characterized by rapid abnormal increase in the number of myeloblasts and progression of symptoms. (AML AML - A Manufacturing Language ) using a variety of dosing schedules ranging from 1- to 24-hour infusions administered weekly to every three weeks. Biological activity was confirmed by direct, dose-dependent activation of the pro-apoptotic proteins bax and bak. Additionally, clinical activity was demonstrated by partial responses in chronic lymphocytic leukemia and follicular lymphomas, prolonged disease stabilization in large cell lymphoma large cell lymphoma n. Lymphoma composed of large mononuclear cells of undetermined type. large cell lymphoma , and hematological hematological, hematologic pertaining to or emanating from blood cells. hematological tests total and differential white cell counts, hematocrit estimation, erythrocyte count. responses resulting in both red blood cell red blood cell: see blood. and platelet transfusion independence. These Phase 1 data have been presented at the 2005 American Society of Hematology (ASH) and 2006 American Society of Clinical Oncology American Society of Clinical Oncology, or ASCO, is an organization that represents all clinical oncologists. Every year, ASCO holds a large symposium where physicians and researchers meet to convey and discuss research and ideas. (ASCO) annual meetings. Additional results from a Phase 1 study in hematological malignancies are expected to be presented at the 2006 American Society of Hematology (ASH) annual meeting in December. "We consider it a great honor that Dr. O'Brien was invited to present an overview of our promising GX15-070 clinical data at this prestigious conference," said Dan Giampuzzi, Gemin X's President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . "After observing encouraging safety data with initial evidence of biological and clinical efficacy in Phase 1 studies, we are now evaluating GX15-070 in Phase 2 single-agent trials in myelofibrosis Myelofibrosis Definition Myelofibrosis is a rare disease of the bone marrow in which collagen builds up fibrous scar tissue inside the marrow cavity. and Hodgkin's lymphoma, and we plan to initiate additional single-agent and combination trials before the end of the year." About GX15-070 GX15-070 is designed to restore apoptosis, the natural process of cell death that is often inhibited in cancer cells. Over-expression of the Bcl-2 protein family inhibits apoptosis and has been observed in a wide range of cancers, including those of the lymph, breast, lung, prostate and colon. GX15-070 is specifically designed to inhibit all of the anti-apoptotic members of the Bcl-2 protein family, thus inducing apoptosis in cancer cells without damaging normal cells, and is the first such small molecule, pan-inhibitor of Bcl-2 proteins tested in clinical trials. Gemin X Biotechnologies Inc. specializes in the discovery and development of novel small-molecule cancer therapeutics based on the regulation of apoptosis, the body's natural ability to destroy injured or damaged cells. Gemin X's lead product, GX15-070, is a small molecule, pan-inhibitor of Bcl-2 proteins in Phase 2 clinical trials. Gemin X is also developing a small molecule that induces apoptosis in p53-defective cancers, which is slated for an IND filing at the end of the year. Gemin X is privately held and is located in Montreal, Quebec and Malvern, Pennsylvania. For additional information please visit Gemin X at www.geminx.com |
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