Gemin X Phase 1 Data Show Clinical Activity of GX15-070 in Myelodysplastic Syndromes
- Data Presented at American Society of Hematology (ASH)
48th Annual Meeting and Exposition -
Montréal, Canada – December 11, 2006 – Gemin X Biotechnologies Inc. announced today results from a Phase 1 clinical trial evaluating GX15-070 administered as a single agent via 24-hour continuous infusion every two weeks in patients with myeloid malignancies and chronic lymphocytic leukemia (CLL). The data indicate that prolonged infusion of GX15-070 induced clinical and biological activity with minimal toxicities. GX15-070 is currently being evaluated in Phase 2 trials as a 24-hour infusion every two weeks in the treatment of Hodgkin's lymphoma and myelofibrosis with myeloid metaplasia.
The data were presented as a poster (Abstract 2654: “A Phase I Trial of the Small Molecule Pan-Bcl-2 Family Inhibitor Obatoclax Mesylate (GX15-070) Administered by 24 Hour Infusion Every 2 Weeks to Patients with Myeloid Malignancies and Chronic Lymphocytic Leukemia (CLL)” [Gautam Borthakur, et al.]) at the American Society of Hematology (ASH) 48th Annual Meeting and Exposition, December 9-12, 2006 in Orlando, FL.
“The biologic and clinical activity observed using a prolonged dosing schedule of GX15-070, combined with the near-elimination of dose-limiting toxicities, supports our current Phase 2 trial protocols,” said Jean Viallet, M.D., Vice President of Clinical Development at Gemin X. “Clinical data have demonstrated GX15-070’s promise in treating several types of hematological and solid tumors, and preclinical studies point to efficacy both as a monotherapy and in combination with other cancer drugs. We look forward to initiating additional Phase 1 and Phase 2 trials next year to evaluate the breadth of GX15-070.”
The Phase 1 trial enrolled 17 patients with myelodysplastic syndromes (MDS), refractory acute myelogenous leukemia (AML) or CLL. Patients received GX15-070 at doses ranging from 7-40 mg/m2 administered as a 24-hour continuous infusion every 2 weeks. The first cycle was administered in a clinical research unit to accommodate pharmacokinetic sampling, but subsequent cycles were administered in an ambulatory setting using portable infusion pumps. A total of 65 infusions were administered. Thus far, 4/8 patients with MDS showed clinical improvement as evidenced by red blood cell or platelet transfusion independence in 3 patients, and bone marrow blasts were reduced from 14 percent to 4 percent in another patient. Biological activity was evidenced by a four-fold increase of histone-oligonucleosomal DNA (ODNA) complexes in 10/14 patients by the midpoint of the infusion, and peaks continued for several days in 9/14 patients. At the recommended Phase 2 dose of 28 mg/m2, adverse events noted were transient Grade 1 dizziness and Grade 2 somnolence in 2/6 patients.
“The transfusion independence and bone marrow blast reductions observed in this trial are very encouraging hints of efficacy for a Phase 1 study,” said Borthakur, leukemia specialist with The University of Texas M. D. Anderson Cancer Center and lead author of the poster. “Additionally, GX15-070 has shown activity in several hematological indications across diverse Phase 1 schedules.”
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 Montréal, Quebec and Malvern, Pennsylvania.
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