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news.The FDA has granted orphan drug status to Morphotek's MORAb-003, a humanized monoclonal antibody, for the treatment of ovarian cancer.
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MORAb-003 is currently being evaluated in a phase II efficacy study in patients with platinum sensitive ovarian cancer. Phase I data have shown that the drug is well-tolerated and has shown signs of clinical activity in patients with advanced, platinum-resistant or refractory ovarian cancer over the course of the treatment period.
“We are very pleased to have received orphan drug designation for MORAb-003 in this indication,” said Dr Nicholas Nicolaides, president and CEO of Morphotek. “This designation further strengthens the MORAb-003 program by offering several clinical development and commercialization benefits.”
Orphan drug designation allows certain tax and user fee benefits including grant funding to help support development as well as a period of marketing exclusivity upon approval, and is granted to new agents that demonstrate promise in the treatment of rare diseases.