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news.Gemin X Biotechnologies has initiated a phase II clinical trial program to evaluate its small molecule GX15-070 in the treatment of several types of cancer.
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GX15-070 is 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 II 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.
“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 Dr Jean Viallet, vice president of Clinical Development at Gemin X.
In phase I studies reported to date, GX15-070 was well-tolerated and resulted in clinical and biological activity.