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Gemin X Biotechnologies Initiates Phase 1/2 Clinical Trial with GX15-070 in Chronic Lymphocytic Leukemia

FDA Grants Orphan Drug Designation for GX15-070 in CLL

Montréal, Canada – January 06, 2005 – Gemin X Biotechnologies Inc. announced today the initiation of a Phase 1/2 clinical trial in chronic lymphocytic leukemia (CLL) with GX15-070, a novel, targeted cancer treatment that is designed to induce apoptosis (natural cell death) by inhibiting the Bcl-2 family of proteins, one of the most validated and well-studied cancer drug targets. Gemin X also announced that GX15-070 has been granted orphan drug status by the U.S. Food and Drug Administration (FDA) for the treatment of CLL.

“The initiation of our second clinical trial in the GX15-070 program and our attainment of orphan drug designation in CLL underscore the dedication of the clinical and regulatory teams at Gemin X,” said Dan Giampuzzi, President and Chief Executive Officer of Gemin X. “The orphan drug program will allow us to efficiently conduct further clinical studies with GX15-070 and, pending positive results, provide this new targeted cancer treatment to patients as quickly as possible.”

The Phase 1/2 trial in CLL is an open-label, dose-escalation study designed to evaluate the safety and tolerability of multiple doses of GX15-070. The trial will also include extensive pharmacokinetic sampling and pharmacodynamic evaluation. GX15-070 will be administered once every three weeks to patients with CLL who have previously been treated with an alkylating agent and Fludarabine.

“GX15-070 is the first small molecule in human trials that targets Bcl-2 proteins, which are involved in many types of cancers,” explained Dr. Thomas Kipps, Deputy Director of UCSD’s Comprehensive Cancer Center and head of the CLL Research Consortium. “In particular, some members of the Bcl-2 family are thought to play a significant role in the etiology of CLL, making this disease a logical choice as a development indication. I look forward to evaluating the compound’s potential in this patient group.”

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. GX15-070 is currently being studied in a separate Phase 1 clinical trial for the treatment of various solid tumor cancers.

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.

About Orphan Drug Designation
Orphan drug designation is an FDA program designed to encourage the development of new treatments for diseases or conditions that affect fewer than 200,000 people in the U.S. Following FDA approval, products with orphan drug designation are eligible for a seven-year period of marketing exclusivity. Additional benefits of orphan drug designation may include protocol assistance, clinical trial support and guidance, grant funding for research and development, tax credits, and reduced filing fees for marketing applications.

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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