Tolero Pharmaceuticals to Expand Enrollment of Phase II Study of Alvocidib in MCL-1–Dependent AML into Europe

SALT LAKE CITY, June 21, 2017 /PRNewswire/ -- Tolero Pharmaceuticals, Inc., a clinical-stage company developing treatments for serious hematological diseases, today announced that it is adding European study centers to its ongoing Phase II clinical trial evaluating alvocidib in the U.S. and Canada for the treatment of MCL-1-dependent relapsed/refractory acute myeloid leukemia (AML).

"Based on our improved understanding of the role that MCL-1 plays in the pathogenesis of AML, we are enlisting additional study centers to expand this important trial into Europe," said David J. Bearss, Ph.D., Chief Executive Officer of Tolero Pharmaceuticals.

Study TPI-ALV-201 (NCT02520011) is a Phase II, randomized, biomarker-driven study for patients with MCL-1 dependent relapsed or refractory AML. The study also includes an exploratory arm in patients with MCL-1-dependent newly diagnosed High-Risk AML. Study TPI-ALV-201 is examining the effectiveness of alvocidib, an investigational inhibitor of cyclin-dependent kinase 9 (CDK9), in combination with the approved agents cytarabine and mitoxantrone in relapsed/refractory AML patients whose leukemia is dependent on MCL-1. Further information about the study can be found at ClinicalTrials.gov.

About Alvocidib
Alvocidib is an investigational agent which is a small molecule inhibitor of cyclin-dependent kinase 9 (CDK9). It is currently in development as part of combination therapy for frontline and MCL-1-dependent relapsed/refractory AML. CDK9 is a protein critical to the regulation of gene expression, including the MCL-1 gene and other important genes involved in cancer. Given the potential role CDK9 de-regulation plays in expression of cancer-associated genes related to cell division and proliferation, CDK9 is an attractive target for the treatment of various cancers.

About MCL-1
MCL-1 is a protein, which, in cancers, serves to block the induction of cell death (apoptosis) and may drive resistance to chemotherapy. Data from previous trials suggest that certain tumors are dependent upon the MCL-1 protein to survive, making it a compelling target. These data indicate that 25%-35% of AML patients have tumors with such dependency, and that treatment with a regimen containing alvocidib, which inhibits production of the MCL-1 protein through blockage of CDK9, can be of benefit to these patients.

About Tolero Tolero Pharmaceuticals is a clinical-stage biopharmaceutical company researching and developing treatments to improve and extend the lives of patients with oncological and hematological diseases. Our diverse pipeline targets important biological drivers of blood disorders to treat leukemias, anemia, and solid tumors, as well as targets of drug resistance and transcriptional control. Tolero is based in the United States and is wholly owned by Sumitomo Dainippon Pharma Co., Ltd., a pharmaceutical company based in Japan.

Additional information about the company and its product pipeline can be found at www.toleropharma.com.

Disclaimer Regarding Forward-Looking Statements
The forward-looking statements in this press release are based on management's assumptions and beliefs in light of information presently available, and involve both known and unknown risks and uncertainties. Any forward-looking statements set forth in this press release are made only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Information concerning pharmaceuticals (including compounds under development) contained within this material is not intended as advertising or medical advice.

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Scott Santiamo
Russo Partners, LLC
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