Neoprobe Corp. announced Monday that FDA has authorized thefirm to start Phase II clinical trials for its breast cancerdetection system, termed radioimmunoguided surgery (RIGS).
The breast cancer RIGS system uses a gamma-ray detectinginstrument to identify monoclonal antibodies labelled withradioactive iodine (125I) that attach specifically to sites ofcancerous tissue. The antibodies are targeted against mucin, atumor-associated glycoprotein that is found in breast, colorectaland ovarian cancers, explained David Bupp, president of theColumbus, Ohio firm.
The cancer patient is injected with the antibodies prior tosurgery. The surgeon uses a hand-held detection device to scanbreast and lymph node areas before and during surgery tolocate and determine the extent of the cancer.
The Phase II trial will be conducted at the University ofFlorida, the University of Pennsylvania Medical Center, LaheyClinic in Boston and the Ohio State University Arthur JamesCancer Hospital and Research Institute.
As well, NeoProbe has submitted to FDA the Phase III protocolfor the pivotal clinical test of its colorectal cancer RIGS system,and has begun Phase II trials of the system in ovarian cancer.
Neoprobe is now using intact monoclonal antibodies in itsdetection system, but is exploring the possibilities ofincorporating single-chain antigen-binding (SCA) proteins aswell. The firm licensed the SCA technology from Enzon Inc. ofSouth Plainfield, N.J. (NASDAQ:ENZN) in August 1992. NeoProbewill be submitting its first investigational new drug (IND)application on such a product "later this quarter," Bupp toldBioWorld.
Neoprobe stock (NASDAQ:NEOP) closed unchanged Monday at$5.75.
-- Jennifer Van Brunt Senior Editor
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