Neoprobe Corporation (OTCBB: NEOP), a diversified developer of
innovative oncology surgical and diagnostic products, announced today
that it has submitted an investigational new drug (IND) amendment to the
United States Food and Drug Administration (FDA) which includes the
design of a proposed Phase 3 clinical trial of Neoprobe’s RIGScan®
CR radiopharmaceutical. RIGScan CR is designed to identify and evaluate
potentially tumor-associated tissue in patients with colon or rectal
cancer. The IND amendment includes a Special Protocol Assessment (SPA)
in accordance with the Prescription Drug User Fee Act of 1992 (PDUFA)
and current regulatory guidelines, and will be registered on www.clincaltrials.gov
following discussions with FDA regarding the SPA.
“The identification of tumor-associated tissue in cancer patients
through the use of biomarkers is of increasing clinical interest and
importance”
The Phase 3 clinical study as currently designed would be a randomized
clinical study that would evaluate the ability of RIGScan CR to identify
tumor-associated tissue in a group of patients as compared to a group of
patients provided with traditional surgical care. The sample size of the
proposed Phase 3 clinical study has been estimated at approximately 250
patients including both the RIGScan CR and traditional treatment groups.
In addition to assessing the ability of RIGScan CR to identify
tumor-associated tissue, the overall survival of the RIGScan CR treated
patients will be compared to the patients treated with conventional
treatment modalities.
“The identification of tumor-associated tissue in cancer patients
through the use of biomarkers is of increasing clinical interest and
importance,” said Dr. Fred Cope, Neoprobe’s Vice President,
Pharmaceutical Research and Clinical Development. “RIGScan CR provided
indications in earlier clinical studies that it could identify
potentially tumor-associated tissue and that the removal of such tissue
might improve patient outcomes. The objective of the proposed Phase 3
trial is to confirm those findings,” concluded Dr. Cope.