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The U.S. Food and Drug Administration has approved a lymphoma drug developed by the privately-held Cambridge-based biotechnology firm Gloucester Pharmaceuticals Inc.
The drug, called Istodax, is approved for the treatment of cutaneous T-cell lymphoma, a type of non-Hodgkin’s lymphoma in patients who have received at least one prior systemic therapy.
The application to the FDA included efficacy data from two studies encompassing 167 patients. Gloucester officials say Istodax is a member of a new class of cancer drugs known as histone deacetylase inhibitors and is expected to be commercially available in January 2010.
Alan Colowick, CEO of Gloucester Pharmaceuticals said in a statement, “The approval of Istodax is a tremendous accomplishment for Gloucester Pharmaceuticals and for the patients we serve. This milestone is also an important step in the continued clinical development path for ISTODAX in oncology. We look forward to presenting data from our registration study of ISTODAX in peripheral T-cell lymphoma in 2010 and continuing further investigation in additional hematologic indications and solid tumors.”
This is Gloucester’s first FDA approval. The company is funded by venture capital firms Apple Tree Partners, based in Cambridge and New York City; Princeton, NJ-based ProQuest Investments; Palo Alto, Calif.-based Prospect Venture Partners; Denmark-based Novo Ventures; and New York-based Rho Ventures.
Cutaneous T-cell lymphoma is a type of non-Hodgkin’s lymphoma, which is a cancer of the immune system. CTCL is caused by a mutation of T cells, unlike most non-Hodgkin’s lymphomas, which are generally of B-cell origin. The malignant T cells involve the skin, causing plaques, patches, erythroderma and/or tumors, in addition to blood, lymph nodes and viscera.
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