Morphotek(R), Inc. Announces FDA Acceptance for the Treatment of Solid Tu

Morphotek(R), Inc., a subsidiary of Eisai Corporation of North America, announced that the U.S. Food and Drug Administration (FDA) cleared its investigational new drug (IND) application to study MORAb-004 in the treatment of patients with solid tumors. MORAb-004 targets endosialin, a protein expressed on cells associated with tumors and tumor blood vessel cells. The IND became effective 30 days after its initial submission to the FDA by Morphotek.

Some researchers have demonstrated that endosialin, the target of MORAb-004, is necessary for the development of new blood vessels (a process called angiogenesis). New blood vessels are required to provide blood flow to tumors for growth. Endosialin is expressed on pericytes which are cells that surround the smallest blood vessels and are needed for the survival, migration and differentiation of small blood vessels.

"The mechanism of action of MORAb-004, the concept of disturbing the tumor environment, is novel in cancer therapy," said Martin D. Phillips, M.D., Morphotek's Chief Medical Officer. "We are pleased to be carrying out the Phase I study with one of the world's leading health care institutions to focus on treating solid tumors and continue clinical development of this potential new treatment."

MORAb-004, which targets the growth of endosialin-expressing cells in tumor blood vessels, will be used to treat patients with solid tumors. Other anti-angiogenesis drugs target tumor endothelial cells, rather than pericytes. Treatment with MORAb-004 offers an alternative means to suppress tumor angiogenesis and growth.

"MORAb-004 is another unique therapeutic antibody being developed by our company that is believed to inhibit tumor growth via a disease-associated pathway identified and studied by one of our collaborative partners," said Nicholas Nicolaides, President and CEO of Morphotek. "Targeting of pericytes is a novel strategy in the anti-angiogenesis field and we look forward to reporting the results of these studies."

Morphotek obtained exclusive rights to develop and commercialize this antibody worldwide from the Ludwig Institute for Cancer Research (LICR). The endosialin protein as well as a precursor monoclonal antibody specific for endosialin, which is related to MORAb-004, were discovered in Dr. Lloyd Old's laboratory at LICR.

Source : news.prnewswire.com