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Celtic Pharma Announces Issuance of U.S. Patent 7,816,323 for Xerecept® in Combination with Avastin® as a Treatment for Breast and Colon Cancers
Date:10/21/2010

ormer Chair of Neuro-Oncology at Memorial Sloan-Kettering Cancer Center commented, "The emerging data from the combination of Xerecept and Avastin is an important development that strongly suggests the need for evaluation of this combination treatment in patients.  Combination therapies are an important part of modern anticancer therapy.  The use of rational combinations of targeted, mechanism-based treatments offers the clinical oncologist the promise of more potent therapeutic options for addressing the multifaceted complexity of cancer."

Celtic Pharma is actively exploring clinical trial strategies to assess combination treatments of Xerecept with Avastin in order to validate these important preclinical findings in a clinical setting, and is also considering the potential for exploring Xerecept in combination with other leading cancer therapies. Celtic Pharma is in productive discussions with the U.S. Food and Drug Administration (FDA) in regards to the design of a registrational study evaluating objectively the clinical benefit associated with reductions in steroid dosing that may be achieved with the use of Xerecept in both primary and metastatic brain tumor patients. Celtic Pharma is also currently evaluating Xerecept in a pediatric trial for patients requiring high doses of corticosteroids to control their cerebral edema, with resulting heavy burdens of steroid-related symptoms.

Preclinical Studies

Several preclinical studies using implanted solid tumor (breast and colon) human xenografts into nude mice, as well as both pediatric and adult human brain tumor xenografts, were evaluated when treated with Xerecept® alone and in combination with Avastin®.  All of these particular models demonstrated statistically significant tumor regression and prolongation of survival following combination treatment with Xerecept and Avastin, compared to Xerecept or Avastin alone.

Specifically, in the human breast model
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SOURCE Celtic Pharmaceutical Holdings L.P.
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