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Phase 1 Clinical Data Demonstrates Gemin X Compound GX15-070 is Well-Tolerated and Generates Biological and Clinical Improvements in CLL

Montréal, Canada – December 12, 2005 – Gemin X Biotechnologies, Inc. announced today that results from a Phase 1/2 clinical trial of GX15-070 (obatoclax) in patients with chronic lymphocytic leukemia (CLL) showed GX15-070 was generally well-tolerated, was biologically active and generated clinical improvements. Principal investigator Susan O’Brien, M.D., leukemia specialist with The University of Texas M. D. Anderson Cancer Center, presented these data (Abstract 446) at the American Society of Hematology’s 47th Annual Meeting and Exposition December 10-13, 2005 in Atlanta, GA during an oral presentation titled “A Phase I Trial of the Small Molecule Pan-Bcl-2 Family Inhibitor GX15-070 Administered Intravenously (IV) Every 3 Weeks to Patients with Previously Treated Chronic Lymphocytic Leukemia (CLL)”. 

The Phase 1/2 clinical trial enrolled 25 patients with Stage I-IV CLL who had failed a median of four prior types of treatment. Of these, 12 patients received GX15-070 at doses of 3.5 – 14 mg/m2 administered as a one-hour infusion, and 13 patients received 20-40 mg/m2 via a three-hour infusion. Thus far, one patient has experienced a partial response and nine patients have had stable disease (>6 weeks). Additionally, 4/14 patients with low platelet counts (baseline <150,000/mm3) showed sustained increases of more than 50% after treatment, while 3/11 anemic patients showed sustained hemoglobin elevations, with two of these patients achieving transfusion independence. Dose limiting toxicities consisted of somnolence, ataxia and dysphoria, which were rapidly reversed. The maximum tolerated dose using a three-hour infusion schedule, once every 3 weeks, was determined to be 28 mg/m2. Pharmacodynamic activity was frequently noted, with apoptosis evidenced by an increase in histone-oligonucleosomal DNA (ODNA) levels 1-6 hours after infusion, peaking 24 to 168 hours after the start of infusion. Analysis showed ODNA peak levels correlated with dose and AUC. Additionally, 18/25 patients showed an average reduction of 29% in peripheral lymphocyte counts.
 
“These results are very exciting because they illustrate that a compound which selectively restores apoptosis in cancer cells can be both biologically active and well tolerated in humans. The absence of side effects commonly associated with cancer treatments is especially encouraging,” said Dan Giampuzzi, President and CEO of Gemin X. “Early evidence of activity has been observed despite the use of a sparse administration schedule. Going forward, we will explore more frequent dosing as well as prolonged infusion schedules to determine the optimal Phase 2 dose and schedule.”

Gemin X is currently conducting a Phase 1 clinical trial with GX15-070 in patients with advanced, refractory solid tumors and expects initial results in 2006. The company plans to initiate additional Phase 1 dosing and combination treatment studies as well as the first Phase 2 studies in the first half of 2006. To date, Gemin X has established multiple collaborations with academic and research institutes to evaluate GX15-070 in a broad spectrum of cancer models.

“The evidence of biological and clinical activity seen at this early stage in the development of a first-in-class cancer agent is both unusual and promising. In particular, hematological improvements seen in anemic and thrombocytopenic patients could be interesting avenues to explore in future clinical work,” said O’Brien. “I look forward to further evaluating GX15-070 in Phase 2 trials and in other indications and treatment combinations.”

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.

About Chronic Lymphocytic Leukemia (CLL)
CLL is a blood cancer that affects an estimated 60,000 Americans and is diagnosed in approximately 8,190 new patients each year in the U.S. alone. Although CLL originates in the white blood cells of the bone marrow, its ability to spread through the blood allows it to metastasize to many different parts of the body including the spleen, lymph nodes and liver. Symptoms may progress over many years and may eventually result in life-threatening complications.

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. Gemin X is also developing small molecules that induce apoptosis in p53-defective cancers. Gemin X is privately held and is located in Montreal, Quebec and Malvern, Pennsylvania.

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