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.
In Phase 1 studies reported to date, GX15-070 was well-tolerated and resulted in clinical and biological activity.
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.
What does all that mean? Let's take this step by step and figure it out. Bcl-2 family members are proteins inside cells that are involved in apoptosis (programmed cell death). For example, cells sense their environment or receive stimuli, and can decide to kill themselves. It is a very regulated process that proceeds step by step until rupture of the membrane. GX15 is targeted to the protein Bcl-2, which when it gets activated, pushes the cell towards apoptosis. The cool thing is that the drug inhibits Bcl-2 (and all it's family members), AND activates proteins such as Bax and Bak, which give a survival signal to the cell.
Lymphomas are immune cell cancers. Myelofibrosis is a disorder of the bone marrow where the marrow is replaced by fibrosis (scar tissue).
Gemin X is a private company in Montreal, Canada.
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