Trovagene Submits Investigational NDA to Initiate Phase 1b/2 PCM-075 Clinical Trial for AML

Trovagene announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to conduct a Phase 1b/2 clinical trial of PCM-075, their polo-like kinase 1 (PLK1) inhibitor for the treatment of patients with acute myeloid leukemia (AML).

A Phase 1 safety study of PCM-075 was previously completed in patients with advanced or metastatic solid tumor cancers.  In this phase 1 study, PCM-075 was administered orally, once daily for five consecutive days, every three weeks, to evaluate drug dosages, drug metabolism, first cycle dose-limiting toxicities (DLTs) and related maximum tolerated dose (MTD). The current phase 1b/2 clinical trial submission is the first study planned to evaluate PCM-075 in patients with hematologic cancers.

"This is an exciting time for Trovagene as we expand our business to precision medicine therapeutics. We are pleased to have our IND and protocol for our Phase 1b/2 clinical trial submitted and under review by the FDA," said Bill Welch, Chief Executive Officer of Trovagene. "There is a critical need for improved therapeutic options to treat AML and we believe PCM-075 holds significant promise for patients suffering from this disease. We look forward to providing additional details on the development of PCM-075 as we move forward with our clinical development plans."

PCM-075 is a highly-selective adenosine triphosphate (ATP) competitive inhibitor of the serine/threonine polo-like-kinase 1 (PLK 1) enzyme, which is over-expressed in several different hematologic malignancies, as well as solid tumors such as breast, prostate, ovarian, lung, gastric and colon cancers. PCM-075 is orally bioavailable and has been explored in an initial Phase 1, open-label, dose-escalation safety study in patients with advanced metastatic solid tumor cancers. Trovagene plans to initiate clinical trials of PCM-075 in AML, since it has significant advantages over prior PLK1 inhibitors evaluated in this indication, including a higher selectivity, greater potency, oral bioavailability and shorter half-life.