Tolero Pharmaceuticals Announces Presentation at AACR Describing a Relationship between Biomarkers and Response to Alvocidib in Patients with Chronic Lymphocytic Leukemia

--Eutropics' Praedicare Dx assay indicates Biomarkers Bim and Hrk May Be Predictive of Patient Response--

AACR Annual Meeting 2014

SALT LAKE CITY--(BUSINESS WIRE)-- Tolero Pharmaceuticals, Inc., a clinical-stage company developing treatments for serious hematological diseases, today announced that a poster related to its development program alvocidib, a potent cyclin-dependent kinase in development for a variety of hematologic disorders, was presented at the 105th Annual Meeting of the American Association for Cancer Research (AACR) in San Diego. The poster, "Bcl-xL Dependence Predicts Response to Alvocidib in Chronic Lymphocytic Leukemia Patients," was presented on Sunday, April 6, 2014, at 1:00 p.m. in collaboration with Eutropics Pharmaceuticals, The Translational Genomics Research Institute, Ohio State University and the Duke Cancer Institute.

"Tolero is evaluating the use of validated biomarkers to define which patients will benefit from treatment with alvocidib and therefore more precisely guide the clinical development of this promising hematology candidate," said David J. Bearss, Ph.D., Tolero's Chief Executive Officer. "By taking a personalized approach to patient treatment, we believe we may be better able to deliver therapy that will improve outcomes while minimizing toxicities."

About the Alvocidib Presentation at AACR

In 62 patients from two completed studies of alvocidib in chronic lymphocytic leukemia (CLL), patient response was correlated with mitochondrial response from pre-treatment specimens to peptides known to interact with proteins that promote cell survival: Bim, Noxa, Bad, Bmf and Hrk. Patients associated with mitochondrial responses to priming with either Bim or Hrk demonstrated an increased response compared with those whose mitochondria did not respond to Bim or Hrk. These two peptides are known to interact with the pro-survival protein, BCL-xL, suggesting that BCL-xL dependence may drive alvocidib efficacy. In addition, tumor lysis syndrome, a cytotoxic effect, was correlated with mitochondrial response to the peptide Bad. The data suggest that mitochondrial priming with Bim and Hrk potentially predict increased response to alvocidib, whereas mitochondrial priming with Bad could predict tumor lysis syndrome, providing Tolero with a potential personalized medicine approach in of patients with CLL.

About Alvocidib

Alvocidib is a potent cyclin-dependent kinase (CDK) small molecule inhibitor in development as a frontline combination therapy for acute myeloid leukemia and relapsed/refractory chronic lymphocyctic leukemia and other hematologic disorders. CDKs are regulatory proteins and enzymes that are critical to a cell's ability to replicate. Because of the key role CDK deregulation plays in runaway cell division and growth, CDK inhibitors remain an attractive target for the treatment of various cancers.

About Chronic Lymphocyctic Leukemia

CLL is a slow-growing cancer in which the bone marrow overproduces abnormal white blood cells, leaving less room in the blood and bone marrow for other types of blood cells, rendering patients vulnerable to serious infection, anemia, easy bleeding and other life-threatening problems. It is the most common leukemia in adults in the U.S., and occurs typically in older individuals. According to the American Cancer Society, over 15,000 new cases of CLL will be diagnosed in 2014, with about 4,600 deaths resulting from the disease.

About Tolero Pharmaceuticals, Inc.

Tolero Pharmaceuticals, Inc., a clinical-stage company, is developing treatments to improve and extend the lives of patients with serious hematological diseases. Our diverse pipeline targets important biological drivers of blood disorders to treat acute and chronic leukemias and anemia. We are well positioned to make a major contribution to clinical strategies that match the right patient with the right drug to alleviate life-threatening blood disorders. For more information, please visit www.toleropharmaceuticals.com.

Tolero Pharmaceuticals, Inc.
Dallin Anderson, 801-285-6003
dallin.anderson@toleropharma.com


Source: Tolero Pharmaceuticals, Inc.

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