Less than a year after Durham drug developer Innocrin Pharmaceuticals closed on $28 million in Series D financing to fund testing of its lead cancer therapies, the company has landed a development boost from the U.S. Food and Drug Administration.
The FDA has granted a fast track designation for Innocrin’s seviteronel (VT-464) for the treatment of patients with metastatic castrate-resistant prostate cancer (CRPC). Fast tracking is a way the FDA speeds its review of promising new therapies targeting unmet medical needs.
“We believe that the award of fast track designation represents important recognition by FDA of seviteronel’s potential to address a significant unmet need in the treatment of patients with CRPC,” said Innocrin CEO William Moore, Ph.D.
The designation from FDA came just ahead of the company’s planned trio of seviteronel presentations later this week at the American Society of Clinical Oncology’s Genitourinary Cancer Symposium in San Francisco.
“We believe that these presentations will raise the profile of a new agent that could make a tremendous impact for patients with very few other treatment options,” said Moore.
Innocrin is developing chemical inhibitors of an enzyme that appears to feed certain cancers. Seviteronel, its leading candidate, is being developed as an oral medication intended to treat hormonally dependent breast cancer as well as CRPC.
Innocrin is running parallel phase two CRPC studies led by the Memorial Sloan Kettering Cancer Center and the National Cancer Institute. The company is also initiating a Sloan Kettering-led phase one/two study in women who have treatment-resistant breast cancer that either expresses the estrogen receptor or does not express any of the accepted treatment biomarkers (triple-negative breast cancer).
Innocrin said it believes CYP17 lyase inhibitors could also be used to treat non-cancer syndromes caused by hormonal excess, including endometriosis, polycystic ovary syndrome and congenital adrenal hyperplasia.
Innocrin was spun out of Durham-based Viamet Pharmaceuticals in October 2014. Viamet is a clinical-stage company that discovers and develops chemical therapies to treat fungal infections.
(C) N.C. Biotechnology Center
