The United States Food and Drug Administration (FDA) has granted orphan drug designations to two investigational cancer drugs under devlopment by Morphotek?, Inc., a subsidiary of Eisai Inc. The drugs are MORAb-004 for the treatment of soft tissue sarcoma and MORAb-066 for the treatment of pancreatic cancer.

The FDA grants this designation to drugs with the potential to treat a rare disease or condition that affects fewer than 200,000 people in the United States. According to data from the National Cancer Institute, in the United States in 2010 the prevalence figure for soft tissue sarcoma was 101,982 and for pancreatic cancer was 32,993.

Significantly improve treatment options
“We are very pleased to receive orphan drug designations for not only one, but two investigational compounds for the potential treatment of cancer,” said Nicholas C. Nicolaides, Ph.D., President and CEO of Morphotek. “We believe that working toward treating disease, no matter the size of the patient population, is essential to the achievement of our human health care mission, which is to give first thought to patients and their families and to increasing the benefits that health care provides. Ultimately, these compounds could significantly improve our ability to provide enhanced treatment options for patients suffering from two very serious diseases.”

Humanized monoclonal antibodies
MORAb-004 is a humanized monoclonal antibody to endosialin/tumor endothelial marker-1 (TEM-1), which is a protein that is expressed in many human malignancies, and which plays a role in tumor development. MORAb-004 binds to TEM-1, and has demonstrated antitumor activity in a variety of nonclinical models. A phase I ascending dose study with MORAb-004 is currently being performed in subjects with a variety of cancers, including soft tissue sarcoma. According to the American Cancer Society, in 2010 about 3,920 people died of soft tissue sarcoma and about 10,520 people were diagnosed with the disease.

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Wide variety of tumor types
MORAb-066 is a humanized monoclonal antibody to tissue factor, which is a protein that plays an important role in blood coagulation. Tissue factor has also been shown to be present in a wide variety of tumor types, including pancreatic cancer. A study published in 2007 (Clin. Cancer Res 13(10): 2870-2875) indicated that tissue factor expression could be observed in a majority of pancreatic cancer tissue samples, but not in normal pancreatic tissue. A separate study (J. Immunother 2004: 27, S11) demonstrated that an antibody to tissue factor inhibits the growth of human pancreatic cancer cells in a xenograft model. According to the American Cancer Society, in 2010 about 36,800 people died of pancreatic cancer and about 43,140 people were diagnosed with the disease.

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