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FDA gives orphan drug status to antimesothelin monoclonal antibody toxin SS1-PE38.(Brief Article)
1902 MAR 28 - (NewsRx.com & NewsRx.net) -- NeoPharm, Inc., (NEOL) announced that it has been granted orphan drug status by the U.S. Food and Drug Administration (FDA) for the company's antimesothelin monoclonal antibody toxin, SS1-PE38, for both the treatment of mesothelioma, a devastating form of lung cancer, and ovarian cancer.
SS1-PE38 targets the mesothelin antigen on tumor cells and delivers the potent cytotoxin PE38 to destroy the tumor cell. NeoPharm has exclusively licensed SS1-PE38 from the National Cancer Institute (NCI) and is developing the compound under a Cooperative Research and Development Agreement (CRADA) with NCI.
"We are pleased to receive the FDA's orphan drug designation for SS1- PE38," said James Hussey, president ...
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Source: HighBeam Research, FDA gives orphan drug status to antimesothelin monoclonal antibody...