AEterna Zentaris Announces Perifosine Receives FDA Fast Track Designation for the Treatment of Refractory Advanced Colorectal Cancer
The Fast Track program of the FDA is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast Track designated drugs ordinarily qualify for priority review, thereby expediting the FDA review process.
A randomized, double-blind Phase 3 trial investigating perifosine in combination with capecitabine (Xeloda(R)) versus placebo in combination with capecitabine (Xeloda(R)) in patients with refractory metastatic colorectal cancer is expected to commence this quarter under a Special Protocol Assessment (SPA) with the FDA.
In addition to colorectal cancer, perifosine is currently in a Phase 3 trial, under a SPA, for the treatment of relapsed/refractory multiple myeloma, with Orphan Drug Status and Fast Track Designation granted. This trial is also sponsored by our partner, Keryx.
Furthermore, the Company received a positive opinion for Orphan Medicinal Product Designation for perifosine from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency for the treatment of multiple myeloma.
Perifosine is a novel, potentially first-in-class, oral anti-cancer agent that modulates Akt, and a number of other key signal transduction pathways, including the JNK and MAPK pathways, all of which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival. The effects of perifosine on Akt are of particular interest because of the importance of this pathway in the development of most cancers, with evidence that it is often activated in tumors that are resistant to other forms of anticancer therapy, and the difficulty encountered thus far in the discovery of drugs that will inhibit this pathway without causing excessive toxicity. High levels of activated Akt (pAkt) are seen frequently in many types of cancer and have been correlated with poor prognosis.
About Colorectal Cancer
According to the American Cancer Society, colorectal cancer is the third most common form of cancer diagnosed in
About AEterna Zentaris Inc.
AEterna Zentaris Inc. is a late-stage drug development company specialized in oncology and endocrine therapy. News releases and additional information are available at www.aezsinc.com.
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