Gemin X Initiates Phase 1/2 Combination Trials with GX15-070 in Non-Small Cell Lung Cancer and Mantle Cell Lymphoma.MONTREAL & MALVERN, Pa. -- Gemin X announced today the initiation of a Phase 1/2 clinical trial of GX15-070 in combination with docetaxel (Taxotere[R]), a chemotherapeutic agent chemotherapeutic agent An agent used to treat CA, administered in 'regimens'-one or more 'cycles' that combine 3 or more agents over wks; CAs are toxic to any cell with a high rate of proliferation–the CA itself, the GI tract–causing N&V, , in patients with non-small cell lung cancer Lung Cancer, Non-Small Cell Definition Non-small cell lung cancer (NSCLC) is a disease in which the cells of the lung tissues grow uncontrollably and form tumors. Description There are two kinds of lung cancers, primary and secondary. (NSCLC NSCLC non (or cancer). NSCLC Non-small cell lung cancer, see there ), and a Phase 1 trial in combination with bortezomib (Velcade[R]), a proteosome inhibitor, in patients with mantle cell lymphoma Mantle cell lymphoma (MCL) is one of the rarer of the non-Hodgkin's lymphomas, comprising about 6% of NHL cases.[1] There are only about 15,000 patients presently in the U.S. (The incidence seems to be somewhat higher in Europe. (MCL MCL - Macintosh Common LISP ). 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 (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. 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 open-label trial Clinical research A trial in which doctors and participants know which therapy is being administered. See Blinding. 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 pharmacodynamics /phar·ma·co·dy·nam·ics/ (-di-nam´iks) the study of the biochemical and physiological effects of drugs and the mechanisms of their actions, including the correlation of their actions and effects with their chemical 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 Myelofibrosis Definition Myelofibrosis is a rare disease of the bone marrow in which collagen builds up fibrous scar tissue inside the marrow cavity. with myeloid metaplasia myeloid metaplasia n. A syndrome characterized by anemia, enlargement of the spleen, and the presence of nucleated red blood cells and immature granulocytes in the blood, and accompanied by extramedullary hematopoiesis in the spleen and liver. . 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 photodynamic therapy n. A type of phototherapy in which a nontoxic light-sensitive compound that has been injected into a patient is exposed selectively to light, whereupon it becomes toxic to targeted malignant and other diseased cells. , 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 Montreal, Quebec and Malvern, Pennsylvania. For additional information please visit Gemin X at www.geminx.com Velcade[R] is a registered trademark of Millenium Pharmaceuticals. Taxotere[R] is a registered trademark of Sanofi-Aventis. |
|
||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion