Morphotek Announces Orphan Drug Status Granted For MORAb-003, A Monoclonal Antibody For The Treatment Of Ovarian Cancer

Main Category: Ovarian Cancer
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 22 Jun 2006 - 0:00 PDT

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Morphotek, Inc. announced today that the United States Food and Drug Administration has granted Orphan Drug Status to MORAb-003, a humanized monoclonal antibody, for the treatment of ovarian cancer.

MORAb-003 is currently being evaluated in a Phase 2 efficacy study in patients with platinum sensitive ovarian cancer. Phase 1 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 Nicholas C. Nicolaides, Ph.D., President and CEO of Morphotek. "This designation further strengthens the MORAb-003 program by offering several clinical development and commercialization benefits."

"We are very optimistic about the prospects for MORAb-003 in the treatment of ovarian cancer," said Martin D. Phillips, M.D., Senior Vice President of Clinical Development for Morphotek. "The Phase 1 results are promising, and the ongoing Phase 2 study is designed to evaluate its efficacy as monotherapy and in combination with standard chemotherapy in platinum-sensitive patients."

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.

Ovarian cancer ranks fourth in cancer deaths among women, accounting for more deaths than any other cancer of the reproductive system (American Cancer Society). In 2005, it is estimated that there will be 22,220 new cases of ovarian cancer in the U.S. and approximately 16,000 women will die from the disease. Worldwide, more than 182,000 new patients will be diagnosed with this form of cancer (World Health Organization).

Morphotek(R), Inc. is a biotechnology company focused on the generation of proprietary organisms 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. This versatile technology has been successfully applied to microbes, plants, and mammals to yield genetically diverse offspring that are suitable for pharmaceutical product development in the areas of antibody and protein therapeutics, high-titer protein manufacturing, and drug target discovery. Morphotek is also marketing an exciting new antibody platform for developing high-quality, fully human therapeutic antibodies that significantly reduces the royalty burdens associated with current technologies. Internally, Morphotek employs its morphogenics technology to develop optimized therapeutic antibodies for the treatment of cancer, inflammatory and infectious diseases. For further information visit http://www.morphotek.com.

Morphotek, Inc.
http://www.morphotek.com

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