Trovagene, Inc. announced that the United States Adopted Name (USAN) Council has approved “Onvansertib” (pronounced on-van-ser-tib) 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). 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), view Onvansertib is a unique representation of the PCM-075 compound and look forward to continuing to advance 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. Onvansertib 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 leukemias, lymphomas and solid tumor cancers. Separate studies with other PLK inhibitors have shown that inhibition of polo-like-kinases can lead to tumor cell death, including a Phase 2 study in Acute Myeloid Leukemia (AML) where response rates of 31% were observed when used in conjunction with a standard therapy for AML (low-dose cytarabine-LDAC) versus treatment with LDAC alone with a 13.3% response rate. A Phase 1 open-label, dose escalation safety study of Onvansertib has been completed in patients with advanced metastatic solid tumor cancers and published in Investigational New Drugs. The maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) in this trial was 24 mg/m 2. Trovagene has an ongoing Phase 1b/2 clinical trial with Onvansertib in AML that was accepted by the National Library of Medicine (NLM) and is now publicly viewable on www.clinicaltrials.gov. The NCT number assigned by clinicaltrials.gov for this study is NCT03303339. Onvansertib has been granted Orphan Drug Designation by the FDA in the U.S. and by the EMA in the European Union (EU) for the treatment of patients with AML. Trovagene is enrolling a Phase 2 trial of PCM-075 in combination with Zytiga® (abiraterone acetate) and prednisone in metastatic Castration-Resistant Prostate Cancer that was accepted by the National Library of Medicine (NLM) and is now publicly viewable on www.clnincaltrials.gov. The NCT number assigned by clinicaltrials.gov for this study is NCT03414034. Onvansertib only targets the PLK1 isoform (not PLK2 or PLK3), is orally available, has a 24-hour drug half-life with reversible on-target hematologic toxicities. Trovagene believes that targeting only PLK1 with reversible on-target activity and an improved dose/scheduling may provide significant clinical benefit with regard to efficacy and safety in patients with various types of cancer. Onvansertib has demonstrated synergy in preclinical studies with numerous chemotherapeutic and targeted agents used to treat leukemias, lymphomas and solid tumor cancers, including FLT3 and HDAC inhibitors, taxanes, and cytotoxins. Trovagene believes the combination of its targeted PLK1 inhibitor, Onvansertib, with other compounds has the potential for improved clinical efficacy in Acute Myeloid Leukemia (AML), metastatic Castration-Resistant Prostate Cancer (mCRPC), Non-Hodgkin Lymphoma (NHL), Triple Negative Breast Cancer (TNBC), as well as other leukemias, lymphomas and solid tumor cancers.