Trovagene Receives USAN Approval for Onvansertib

Trovagene announced the United States Adopted Name (USAN) Council has approved Onvansertib as the nonproprietary (generic) name for its drug candidate, PCM-075. Onvansertib is a first-in-class, 3rd generation, highly selective, oral Polo Like Kinase 1 (PLK1) inhibitor, that is designed to target and inhibit cancer cell division (mitosis).

"Assignment of a unique generic name is a very meaningful step forward for our drug candidate, PCM-075," said Dr. Thomas Adams, Executive Chairman of Trovagene. "With Orphan Drug status in both the U.S. and Europe for the treatment of acute myeloid leukemia (AML) and an ongoing Phase 1b/2 clinical trial in this indication, along with an active Phase 2 clinical trial in metastatic Castration-Resistant Prostate Cancer (mCRPC), we view Onvansertib as a novel representation of the PCM-075 compound and we look forward to continuing to advance our clinical development program across a wide array of cancers."

Onvansertib is highly selective only for PLK1 which is over-expressed in tumor cells, has on-target (expected) and reversible side effects associated with the mechanism of action and interaction with its intended target, is orally administered with an ideal half-life of approximately 24 hours, and has demonstrated synergistic activity (the interaction of two or more drugs that produces a combined effect greater than the sum of their individual effects) in combination with numerous approved chemotherapies and targeted therapeutics.

The United States Adopted Names (USAN) Council, part of the American Medical Association (AMA), is responsible for selecting simple, informative and unique nonproprietary (generic) drug names.

 --------------------------------------------------------------------------------------------------------------------------

Editor's Note:

To apply for becoming a contributor of en-CPhI.cn,

welcome to send your CV and sample works to us,

Email: Julia.Zhang@ubmsinoexpo.com.