Two biopharmaceutical companies took a step forward this week with their pipelines for advanced breast cancer. Sopherion Therapeutics of Princeton, NJ, has received Fast Track Designation for Myocet to treat metastatic breast cancer. Meanwhile, Enzon Pharmaceuticals announced the commencement of a Phase II clinical trial for PEG-SN38.
The U.S. Food and Drug Administration grants Fast Track Designation to drugs that fulfill an unmet clinical need, expediting the review process and allowing new treatments to reach the market more quickly. Sopherion’s Myocet is a liposome-encapsulated form of the breast cancer drug doxirubicin. In its conventional form, doxirubicin is known to cause cardiac toxicity. Studies have indicated that Myocet reduces cardiotoxicity compared to traditional doxirubicin. Sopherion hopes to have data from an ongoing Phase III trial of Myocet by the end of 2010. The study will examine Myocet combined with Taxol and Herceptin as a treatment for metastatic breast cancer.
In related news, Enzon has begun treating the first patient in a Phase II study of PEG-SN38 (or EZN-2208). Much like Sopherion’s Myocet, PEG-SN38 is intended to deliver a less-toxic form of a traditional cancer drug. PEG-SN38 utilizes Enzon’s proprietary PEGylation technology. The platform delivers injectable drugs through the chemical attachment of polyethylene glycol via a linker, with the goal of improving therapeutic effectiveness. PEG-SN38 is currently undergoing Phase II clinical trials for colorectal cancer. Shares in Enzon have been up 25 percent in the past three months, according to trading website optionMONSTER.
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