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Pharma & Bio Ingredients
Interim results from a Phase 1/2 study of PDX in patients with relapsed or refractory non-Hodgkin's lymphoma (NHL) and Hodgkin's disease currently on-going at Memorial Sloan-Kettering Cancer Center demonstrated preliminary evidence of activity in patients with various subtypes of aggressive and chemotherapy resistant T-cell lymphoma. As reported at the 2005 American Society of Hematology Annual Meeting, four of seven evaluable patients with T-cell lymphoma achieved a complete response following treatment with PDX, despite having failed multiple prior chemotherapies. The addition of vitamins to the treatment regimen appeared to successfully mitigate the previously established dose-limiting toxicity of stomatitis.
The U.S. Orphan Drug Act is intended to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders. Under the Orphan Drug Act, the FDA will not accept or approve other applications from other sponsors to market the identical medicinal products for the same therapeutic indication for a seven-year period once a designated orphan drug is approved for marketing. In addition to potential market exclusivity, orphan drug designation provides potential protocol assistance, advice on the conduct of clinical trials, tax credits for clinical research expenses, grant funding for research of rare disease treatments and waiver of the Prescription Drug User Fee Act (PDUFA) filing fee for the drug's sponsor.
