space space   
 

News

 2007 | 2006 | 2005 | Archived
   
Gemin X Initiates Phase 1/2 Combination Trials with GX15-070 in Non-Small Cell Lung Cancer and Mantle Cell Lymphoma

Montréal, QC and Malvern, PA – January 31, 2007 – Gemin X announced today the initiation of a Phase 1/2 clinical trial of GX15-070 in combination with docetaxel (Taxotere®), a chemotherapeutic agent, in patients with non-small cell lung cancer (NSCLC), and a Phase 1 trial in combination with bortezomib (Velcade®), a proteosome inhibitor, in patients with mantle cell lymphoma (MCL).  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. 

“These trial initiations are part of our strategy to rapidly evaluate the breadth of our lead product candidate, GX15-070, in multiple cancer indications utilizing multiple combinations,” said Dan Giampuzzi, President and CEO at Gemin X.  “GX15-070 has demonstrated clinical and biological activity in five cancer indications, administered as a single agent in highly refractory and heavily pre-treated patients. We are optimistic about its ability to treat NSCLC and MCL, especially given that Bcl-2 proteins are frequently over-expressed in these diseases. Inhibition of Bcl-2 has been shown to enhance current treatments in these indications, so the ability of GX15-070 to inhibit Bcl-2 proteins may enhance the therapeutic effects of docetaxel and bortezomib.”

The open-label trial in NSCLC will enroll a maximum of 41 patients with relapsed or refractory NSCLC at three to five study centers. Patients will receive infusions of both GX15-070 and docetaxel. The primary endpoint of the Phase 1 portion of the study will be to identify the recommended Phase 2 dose, while the Phase 2 portion of the study will focus on overall response rate. Safety, tolerability, pharmacokinetics and pharmacodynamics will also be evaluated.

The trial in MCL is an open-label trial and will enroll a maximum of 18 patients with relapsed or refractory MCL at multiple sites within the U.S.  GX15-070 will be administered in combination with bortezomib in 3-week cycles.  The primary endpoints of this study will be to determine the response rate to GX15-070 in combination with bortezomib and to characterize its safety profile.

Gemin X recently initiated Phase 2 clinical trials with GX15-070 in patients with Hodgkin’s Lymphoma and in myelofibrosis with myeloid metaplasia. In multiple Phase 1 studies, GX15-070 was well-tolerated and resulted in clinical and biological activity.

About Non-Small Cell Lung Cancer (NSCLC)
Non-small cell lung cancer constitutes 85% of all lung cancers, affecting nearly 150,000 men and women each year.  Nearly 60% of lung cancer patients die within one year of diagnosis, and approximately 75% die within 2 years, a mortality rate that has not improved in the past decade. Available treatments include surgery, chemotherapy, radiation, laser therapy and photodynamic therapy, but for most patients these options do not offer a cure.

About Mantle Cell Lymphoma (MCL)
Mantle cell lymphoma (MCL) belongs to a group of diseases known as non-Hodgkin's lymphomas, which are related cancers that affect the lymphatic system.  Mantle cell lymphoma is an aggressive B-cell lymphoma that historically been resistant to current standard chemotherapeutic approaches making it a difficult cancer to treat.  The median survival for MCL patients is 2 to 5 years. 

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 and is currently in Phase 2 clinical trials. Gemin X is also developing a small molecule that induces apoptosis in p53-defective cancers. Gemin X is privately held and is located in Montréal, Quebec and Malvern, Pennsylvania.

Velcade® is a registered trademark of Millenium Pharmaceuticals. Taxotere® is a registered trademark of Sanofi-Aventis.

return to top