EXTON, Pa., Feb. 13 /PRNewswire/ -- Morphotek, Inc. today announced that the United States Food and Drug Administration (FDA) cleared its investigational new drug application (IND) for MORAb-009 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. The IND became effective 30 days after its initial submission to the FDA by Morphotek.
"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 Martin D. Phillips, M.D., 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."
"Last year we opened our first IND for the treatment of advanced ovarian cancer and the acceptance by FDA of this second IND represents a major milestone for our company," remarked Philip Sass, EVP and COO. "The company has developed a deep pipeline of oncology, immunology and infectious disease candidates and an infrastructure to sustain filing and support simultaneous clinical programs. We are on schedule to file our third IND in oncology later this year."
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. In the US, pancreatic cancer patients have a 5-year survival rate of 4% (American Cancer Society, 2005).
Significant opportunities exist for drugs that can help prolong the survival of patients with mesothelin-expressing tumor types as well offer additional clinical benefits such as a lack of serious side effects and improvement of quality of life. To this end, Morphotek is fully committed to developing MORAb-009 to its maximum potential.
Morphotek, Inc. is a biotechnology company focused on the generation of proprietary proteins for product discovery and development. The Company has a validated and patented platform technology called morphogenics that rapidly enhances the natural process of genetic evolution within a targeted host to yield variants with novel, commercially important output traits. Morphotek markets an antibody development platform called Human MORPHODOMA(R) that employs morphogenics to yield fully human, high-affinity MAbs from high-titer hybridoma cells. The platform is also employed as a discovery tool to generate libraries of hybridomas yielding fully-human MAbs for the diagnosis and treatment of diseases in humans. Both platforms bypass the burdensome royalty stacking issues associated with recombinant antibody technologies. Internally, Morphotek employs its technologies to develop optimized therapeutic antibodies for the treatment of cancer, inflammatory and infectious diseases. For further information visit http://www.morphotek.com.
Contact: Kimberly Ilgenfritz Executive Director, Business Development & Marketing Phone: 610-423-6147 or e-mail: info@morphotek.com
Morphotek, Inc.CONTACT: Kimberly Ilgenfritz, Executive Director, Business Development &Marketing, Morphotek, Inc., +1-610-423-6147 or e-mail: info@morphotek.com
Web site: http://www.morphotek.com/
