Human AML xenograft with FLT3 mutation shows PCM-075 in combination with Quizartinib resulted in 96% tumor growth inhibition with tumor regression

SAN DIEGO, CA, USA I August 16, 2017 I Trovagene, Inc. (NASDAQ:  TROV), a precision medicine biotechnology company, today announced positive data from a preclinical in-vivo study examining the combination of their PLK1 inhibitor, PCM-075, with a leading investigational FLT3 Inhibitor.  This FLT3 mutant xenograft model shows PCM-075 in combination with Quizartinib resulted in 96% tumor growth inhibition versus monotherapy with Quizartinib (81%) or PCM-075 (76%).  This research data is planned for future publication.

“Thirty percent of patients with AML harbor a FLT3 mutation. This represents an opportunity for combination therapy with PCM-075,” said Bill Welch, CEO of Trovagene. “We are encouraged by this initial preclinical data as we continue to identify potential combination therapies using PCM-075 within diverse AML patient populations.”

About PCM-075

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 multiple hematologic malignancies, as well as solid tumors such as adrenocortical, 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.

About Acute Myeloid Leukemia

Acute myeloid leukemia (AML) is a hematologic malignancy in which myeloid lineage cells of the bone marrow cease to differentiate appropriately, resulting in a marked increase in the number of circulating immature blast cells. As a consequence, the counts of mature red blood cells, platelets, and normal white blood cells decline, causing fatigue, shortness of breath, bleeding, and increased susceptibility to infection. Patients harboring mutations in the FLT3 receptor tyrosine kinase have a particularly poor prognosis; however, significant progress has been made by the emergence of a variety of targeted inhibitors capable of suppressing FLT3 signaling. This has prompted the development of second-generation FLT3 inhibitors, led by Quizartinib (Daiichi Sankyo), which has demonstrated enhanced FLT3 specificity and have been generally well tolerated in clinical trials. Molecular insights provided by FLT3 inhibitors have shed light upon the variety of mechanisms underlying the acquisition of resistance and have provided a rationale supporting the use of combination regimens with other emerging targeted therapies.

About Trovagene, Inc.

Trovagene is a precision medicine biotechnology company developing oncology therapeutics for improved cancer care by leveraging its proprietary Precision Cancer Monitoring® (PCM) technology in tumor genomics.  Trovagene has broad intellectual property and proprietary technology to measure circulating tumor DNA (ctDNA) in urine and blood to identify and quantify clinically actionable markers for predicting response to cancer therapies.  Trovagene offers its PCM technology at its CLIA/CAP – accredited laboratory and plans to continue to vertically integrate its PCM technology with precision cancer therapeutics.  For more information, please visit

SOURCE: Trovagene