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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