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Morphotek cleared to begin clinical testing of anticancer drug

The FDA has given its approval for Morphotek to move its investigational drug MORAb-009 into clinical testing for the treatment of mesothelin-expressing cancers.

Preclinical data indicate that mesothelin is highly over-expressed in tumors of patients with pancreatic adenocarcinoma and other prevalent cancers including non-small lung carcinoma, ovarian carcinoma and mesotheliomas.

Research has shown MORAb-009 to inhibit tumor growth by inhibiting mesothelin binding to extracellular substrate and also through antibody dependent cellular cytotoxicity.

Morphotek obtained exclusive rights to develop and commercialize this antibody worldwide from the National Cancer Institute where the mesothelin protein and its expression association with various cancer types were discovered.

“MORAb-009’s mechanism of action suggests that it will be useful and well- tolerated in pancreatic cancer and other tumors that express mesothelin,” commented Dr Martin Phillips, senior VP, clinical development. “We have aligned ourselves with the world’s leading health care institutions focused on treating pancreatic cancer. We look forward to commencing the first phase I study at these centers and the potential of improving the prognosis for these patients.”

MORAb-009 will initially be developed for the treatment of patients with advanced pancreatic cancer. According to the World Health Organization, approximately 232,000 patients were diagnosed worldwide with pancreatic cancer in 2002, and 227,000 deaths from the disease were reported.