Jan 12 2010
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.
“The filing of the SPA request follows our successful discussions with
the centralized European regulatory authorities (the EMEA) under their
Scientific Advice process,” said David Bupp, Neoprobe’s President and
CEO. “Dr. Cope and his team have completed an extensive scientific
literature evaluation to support the design of the Phase 3 study and we
initiated the biologic development activities to support the proposed
Phase 3 study in 2009. The commencement of an evaluation of the Phase 3
study design under the SPA provisions is an important step in the
development of RIGScan CR. The proposed trial design incorporates both
diagnostic and therapeutic endpoints for the RIGS technology,” concluded
Mr. Bupp.
RIGScan CR, when used with a commercially available hand-held gamma
radiation detection probe, provides surgeons with real-time information
used to locate tumor components not detectable by conventional methods,
and assist in the more thorough removal of the potentially cancerous
tissue. The RIGScan CR targeting agents are monoclonal antibodies
labeled with a radioactive isotope that emits low energy gamma rays.
Before surgery, a cancer patient is injected with the monoclonal
antibody targeting agent, which circulates throughout the patient’s body
and binds specifically to cancer cell components (cancer antigens).
Concentrations of the targeting agent are then located during surgery by
the gamma detection device, which emits an audible tone to direct the
surgeon to tumor-involved tissue. Information on the clinical history
and current development status of RIGScan CR can be obtained from
Neoprobe’s previous press releases and filings with the U.S. Securities
and Exchange Commission.
http://www.neoprobe.com/