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Gemin X Biotechnologies Initiates Phase 2 Clinical Trial Program for GX15-070 In Myelofibrosis and Hodgkin's Lymphoma

Montréal, Canada – September 14, 2006 – Gemin X Biotechnologies Inc. announced today the initiation of a Phase 2 clinical trial program to evaluate GX15-070 in the treatment of several types of cancer. 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.

Phase 2 trials have been initiated in Hodgkin’s Lymphoma and in myelofibrosis with myeloid metaplasia. Both trials are multi-center, open-label, single agent studies that will be conducted in North America at the M.D. Anderson Cancer Center and other locations. The Hodgkin’s Lymphoma trial will enroll 10-29 patients and the myelofibrosis trial will enroll 19-55 patients.  The primary endpoint of the trials is tumor response, and safety, pharmacokinetics and pharmacodynamics will also be measured.  Additional information about the trials is available at www.clinicaltrials.gov.

“These new Phase 2 studies are designed to build upon the encouraging results from our recently completed dose-escalation studies.  We have now treated over 65 patients with GX15-070 as a single agent in heavily pre-treated and highly refractory patient populations, and we have seen evidence of clinical activity across four cancer indications,” explained Jean Viallet, M.D., Vice President of Clinical Development at Gemin X.  “In addition, we have observed definitive biological activity that confirms the inhibition of the target Bcl-2 family proteins and activation of Bax and Bak in circulating leukemia cells. We have also observed a dose-dependent response of plasma oligonucleosomal DNA release in the majority of patients treated, which demonstrates the activation of the apoptotic cascade.”

In Phase 1 studies reported to date, GX15-070 was well-tolerated and resulted in clinical and biological activity.

A Phase 1b study in 25 patients with chronic lymphocytic leukemia (CLL) demonstrated that GX15-070 administered at doses of 3.5 to 40 mg/m2 as a one to three hour infusion resulted in a partial response and frequent hematological improvement including the achievement of red blood cell transfusion independence in two patients.  This study was presented at the 2005 American Society of Hematology (ASH) annual meeting by Dr. Susan O’Brien 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)”.

A second Phase 1 trial in 18 patients with refractory solid tumors or lymphomas demonstrated that GX15-070 administered at doses ranging from 5 to 20 mg/m2 resulted in six patients with stable disease from 15 to 47+ weeks.  The interim study data were presented at the 2006 American Society of Clinical Oncology (ASCO) annual meeting in a poster entitled “A Phase I Study of the Pan-Bcl2 Family Inhibitor GX15-070, Administered as a 3-hour Weekly Infusion in Patients with Refractory Solid Tumors or Lymphomas” (Abstract 3081; Kashif Alam Firozvi, et al).

Results from a third study in hematological malignancies are expected to be presented at the American Society of Hematology (ASH) annual meeting this coming December.

About Hodgkin’s Lymphoma
Hodgkin's Lymphoma is a cancer that starts in lymphatic tissue, most often in lymph nodes in the upper part of the body such as within the chest, neck or underarms. It is characterized by progressive enlargement of lymph nodes, spleen and liver and by progressive anemia.  Hodgkin’s Lymphoma is a tumor of B-cell origin characterized by the presence of Reed-Sternberg (RS) cells.  The altered expression of Bcl-2 and other family members in RS cells may prevent apoptosis caused by the absence of the functional B-cell receptor and explain resistance to chemotherapy-induced apoptosis and treatment failure in select patients.

 

About Myelofibrosis with Myeloid Metaplasia
Myelofibrosis with myeloid metaplasia is a chronic myeloproliferative disease that causes secondary scarring or “fibrosis” in the bone marrow. It can lead to progressive bone marrow dysfunction, anemia, and decreases in other key blood cells such as infection-fighting white blood cells and blood-clotting platelets. Currently available treatments cannot cure or permanently slow the progression of myelofibrosis, but the standard of care for patients in otherwise good health and for whom a donor can be found is a bone marrow or stem cell transplant.

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.

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