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Neoprobe takes on Investigational New Drug Application for RIGScan to target tumors in colorectal cancer
By E. Janene Geiss
Philadelphia, Nov. 7 - Neoprobe Corp. announced Monday that the U.S. Food and Drug Administration has accepted its request to establish a corporate Investigational New Drug application for modified chimeric version of RIGScan CR.
With the established corporate application, the responsibility for the clinical and commercial development of this humanized version of RIGScan CR has been officially transferred from a physician-sponsored application to NeoProbe, according to a company news release.
RIGScan is a proprietary radiolabeled cancer targeting agent that provides the surgeon with real-time information during surgery to locate tumor deposits in colorectal cancer patients that may not be detectable by conventional methods, officials said.
Previous RIGS clinical trials sponsored by Neoprobe were conducted using a murine, or mouse-DNA-based, version of the RIGScan CR antibody. Due to general concerns regarding the use of murine antibodies in human patients, humanized versions of the RIGScan CR antibody, from which the prominent parts of the mouse DNA chain have been removed, were developed following Neoprobe's earlier trials, officials said.
Following these development activities, independent clinical investigators completed a phase I clinical trial using a humanized version of RIGScan CR under a physician-sponsored Investigational New Drug Application, officials said.
Sponsorship for that application now is being transferred to Neoprobe so that development of this humanized version may move forward under our corporate sponsorship, officials said.
"We believe moving forward with a humanized version of RIGScan CR will address a number of concerns raised by FDA and will ultimately result in a more producible, reliable and effective drug," David C. Bupp, Neoprobe's president and chief executive officer, said in the release.
Neoprobe is a Dublin, Ohio-based biomedical company.
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