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news.Gemin X Biotechnologies has initiated a phase I/II clinical trial in chronic lymphocytic leukemia with novel cancer treatment GX15-070. The company also announced that the compound has been granted orphan drug status by the FDA for this indication.
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GX15-070 is a novel, targeted cancer treatment designed to induce apoptosis (natural cell death) by inhibiting the Bcl-2 family of proteins, one of the most validated and well-studied cancer drug targets. Over-expression of the Bcl-2 protein family inhibits apoptosis and has been observed in a wide range of cancers, including those of the lymph, breast, lung, prostate and colon.
The phase I/II trial in chronic lymphocytic leukemia (CLL) is an open-label, dose-escalation study designed to evaluate the safety and tolerability of multiple doses of GX15-070. The trial will also include extensive pharmacokinetic sampling and pharmacodynamic evaluation.
GX15-070 will be administered once every three weeks to patients with CLL who have previously been treated with an alkylating agent and Fludarabine (marketed by Berlex and Ben Venue Laboratories as Fludara).
“The orphan drug program will allow us to efficiently conduct further clinical studies with GX15-070 and, pending positive results, provide this new targeted cancer treatment to patients as quickly as possible,” said Dan Giampuzzi, president and CEO of Gemin X.
GX15-070 is also currently being studied in a separate phase I clinical trial for the treatment of various solid tumor cancers.