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news.Pennsylvania-based biotech company Morphotek has revealed that the FDA has accepted the company's investigational new drug application for the treatment of advanced ovarian cancer with MORAb-003.
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The phase I clinical study is designed as an open label single dose escalation safety study in patients with chemo-refractive ovarian cancer.
MORAb-003 is a monoclonal antibody that has high specificity for a number of different cancers, including ovarian, breast, colorectal, lung, renal, and brain. In preclinical cancer models the antibody has demonstrated that it can efficiently kill chemo-refractory tumors and suppress growth in xenograft studies.
“This is the first of several antibodies in our product portfolio that the company plans on advancing into clinical development for cancer, inflammation and infectious diseases,” stated Philip Sass, executive vice president and COO of Morphotek.
Morphotek is also developing a second monoclonal antibody, named MORAb-009. This antibody targets pancreatic cancers and the company expects to file an investigational new drug (IND) application for the drug candidate by the end of 2005.