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Tigris Pharmaceuticals Initiates Randomized Phase 2 Study of AFP-464 in ER-Positive Breast Cancer Patients

Thu, 05/26/2011 - 12:34pm
Bio-Medicine.Org

BONITA SPRINGS, Fla., May 26, 2011 /PRNewswire/ -- Tigris Pharmaceuticals, Inc., today announced enrollment of its first patient in a randomized Phase 2 clinical trial of AFP-464 (aminoflavone prodrug) with or without Faslodex® (fulvestrant) in estrogen receptor (ER)-positive breast cancer patients. Molecular profiling will be used to pre-screen patients for a biomarker called Aryl Hydrocarbon Receptor (AhR), which has shown to predict sensitivity to AFP-464.

It is estimated that approximately 70 percent of breast cancers are ER-positive (1).

"The promise of personalized medicine is being realized with this study of AFP-464," said Edmundo Muniz, M.D., Ph.D., president and chief executive officer of Tigris Pharmaceuticals. "Matching specific markers and gene variations to particular medicines is a more efficient way of developing new anti-cancer agents and more importantly, will enable doctors to make more informed prescribing decisions, reducing risks of side effects and increasing chances of treatment success."

The primary endpoint of the study is to determine the percentage of patients that achieve a Clinical Benefit Response.

The randomized, proof-of-concept trial is led by Joanne Blum, M.D., Ph.D., director of the Hereditary Cancer Risk Program at Baylor-Sammons Cancer Center in Dallas, Texas. The study is open for accrual with the US Oncology Research Network, the largest community-based cancer research network in the nation.

"We are fortunate there are approved therapies to treat metastatic breast cancer, but the majority of patients with this disease will become refractory during  treatment," said Dr. Blum. "This study is exciting in that it may have the potential to improve our ability to deliver targeted cancer therapy at the outset of treatment providing another option for these patients.  Additionally, this agent may help to overcome endocrine resistance, one of the major problems for patients

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