Eutropics Pharmaceuticals to Present Data on Personalized Diagnostic for AML Patient Management at ASCO 2013

May 22, 2013

Study using Novel Biomarker Technology Indicates Potential Medical Utility in Discriminating Clinical Outcomes

CAMBRIDGE, Mass.--(BUSINESS WIRE)--

Eutropics Pharmaceuticals Inc. announced today that Eutropics and The University of Texas MD Anderson Cancer Center will present results from a clinical study employing Eutropics’ proprietary PraediCare Dx (BH3 profiling) assay to discriminate therapeutic response in acute myeloid leukemia (AML) patients to standard-of-care-based chemotherapy. The presentation entitled “BH3 Profiling is a Predictive Biomarker for Response to Cytarabine-based Treatment of Acute Myelogenous Leukemia” will be delivered in a poster-discussion session during the Annual Meeting of the American Society of Clinical Oncology (ASCO) being held May 31-June 4, 2013 in Chicago. The poster-discussion session is on Saturday, June 1 from 12 p.m. to 1 p.m. CDT in room S406.

In the study, investigators from Eutropics and The MD Anderson Cancer Center collaboratively examined specimens derived from a cohort of 62 AML patients prior to treatment with cytarabine-based treatment regimens using PraediCare Dx. This BH3 profiling technology, exclusively licensed to Eutropics from Dana-Farber Cancer Institute, assesses pro-apoptotic signaling of BCL-2 family proteins and thus a cell’s propensity to undergo programmed cell death (apoptosis) to model therapeutic response. In the study, a correlation between PraediCare Dx biomarker metrics and clinical response achieved pronounced statistical significance (p = 1.8x10-6). When combined with age and other clinical variables, the test was able to discriminate responders from non-responders with 90% accuracy.

Michael Andreeff, M.D., Ph.D., the Paul and Mary Haas Chair in Genetics, Professor of Medicine and Chief, Section of Molecular Hematology and Therapy, MD Anderson Cancer Center, and principal investigator on the study said, “These preliminary results are especially exciting and portend application of personalized diagnostics approaches, including PraediCare Dx, to AML patient management with the goal of achieving improved outcomes.”

“We are building a strong record of publications and clinical studies to support PraediCare Dx, which by stratifying patients based on their predicted response to standard-of-care could improve outcomes and reduce healthcare costs,” added Michael Cardone, Ph.D., President and CEO of Eutropics. “We are pleased to move towards clinical utility of the PraediCare Dx assay, as we conduct additional studies with our colleagues at The MD Anderson Cancer Center.”

About PraediCare Dx

Eutropics’ PraediCare Dx platform technology delivers medically useful in vitro diagnostic assays. The tests may improve patient outcome by directing the best treatment options and also may provide a biomarker for guided cancer drug development. Based on clinical evidence, the PraediCare Dx technology platform delivers unique understanding into a cancer cell’s ability to respond to chemotherapies that induce programmed cell death (apoptosis), enabling the physician to choose the treatment option most likely to benefit the individual patient.

Tests based on the PraediCare Dx technology are being investigated for use in treating acute myelogenous leukemia (AML) and multiple myeloma (MM). A recently completed validation study in uniformly treated AML patients indicate that the test provides actionable data to physicians. PraediCare Dx is currently being verified in repeat studies with academic and pharmaceutical partners. These validation studies for predicting response to standard-of-care are anticipated to be completed in fourth quarter of 2013. Tests for CLL, ALL and DLBCL have been developed for future clinical studies.

About Eutropics Pharmaceuticals

Eutropics is addressing the need for improving the treatment of aggressive forms of leukemia, myeloma, lymphoma, and other cancers. The company is developing a novel diagnostic technology that will guide the use of established and experimental therapeutics, enabling the delivery of personalized medicines to patients suffering from cancer. www.eutropics.com

Contact:
Eutropics Pharmaceuticals
Michael H. Cardone, Ph.D., 617-714-4405 Ext. 112
mcardone@Eutropics.com
or
For Media:
MacDougall Biomedical Communications
Charles Liles, 781-235-3060
cliles@macbiocom.com

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