-- Meeting Scheduled for 1st Quarter of 2011 --
DUBLIN, Ohio--(BUSINESS WIRE)-- Neoprobe Corporation (OTCBB: NEOP), a diversified developer of innovative oncology surgical and diagnostic products, today announced that it has requested and been granted a Type B pre-IND meeting with the U.S. Food and Drug Administration (FDA) regarding its RIGS® technology Biologic License Application (BLA). The pre-IND meeting request is another step in Neoprobe’s efforts to develop and commercialize the RIGS technology designed to enhance the surgical treatment of patients with solid tumor cancers.
“The pre-IND meeting request is one of several near-term activities that Neoprobe intends to complete with FDA to reactivate the development of the RIGS technology program,” said Rodger Brown, Neoprobe’s Vice President of Regulatory Affairs and Quality Assurance. “The FDA has confirmed a meeting date in the first quarter of 2011 and we are in the process of completing the briefing documents in preparation for this meeting. Once FDA has agreed with our RIGS development plans, and has assigned a new IND, we anticipate more extensively restarting our clinical, non-clinical and CMC efforts including pursuing the possibility of obtaining a Special Protocol Assessment (SPA) for the clinical evaluation of the RIGS technology.”
Neoprobe’s RIGS technology involves the use of a radiolabeled tumor-specific targeting agent to alert surgeons to the existence of cancerous tissue, undetectable by traditional diagnostic and intraoperative techniques. The RIGS procedure may enable more effective colorectal cancer surgeries leading to improved patient treatment.
About Neoprobe Corporation
Neoprobe Corporation (OTCBB: NEOP) is a biomedical company focused on enhancing patient care and improving patient outcome by meeting the critical intraoperative diagnostic information needs of physicians and therapeutic treatment needs of patients. Neoprobe currently markets the neoprobe® GDS line of gamma detection systems that are widely used by cancer surgeons. In addition, Neoprobe holds significant interests in the development of related biomedical systems and radiopharmaceutical agents including Lymphoseek® and RIGScan™. Neoprobe’s subsidiary, Cira Biosciences, Inc., is also advancing a patient-specific cellular therapy technology platform called ACT. Neoprobe’s strategy is to deliver superior growth and shareholder return by maximizing its strong position in gamma detection technologies and diversifying into new, synergistic biomedical markets through continued investment and selective acquisitions. www.neoprobe.com
Statements in this news release, which relate to other than strictly historical facts, such as statements about the Company’s plans and strategies, expectations for future financial performance, new and existing products and technologies, anticipated clinical and regulatory pathways, and markets for the Company’s products are forward-looking statements The words “believe,” “expect,” “anticipate,” “estimate,” “project,” and similar expressions identify forward-looking statements that speak only as of the date hereof. Investors are cautioned that such statements involve risks and uncertainties that could cause actual results to differ materially from historical or anticipated results due to many factors including, but not limited to, the Company’s continuing operating losses, uncertainty of market acceptance of its products, reliance on third party manufacturers, accumulated deficit, future capital needs, uncertainty of capital funding, dependence on limited product line and distribution channels, competition, limited marketing and manufacturing experience, risks of development of new products, regulatory risks and other risks detailed in the Company’s most recent Annual Report on Form 10-KSB and other Securities and Exchange Commission filings. The Company undertakes no obligation to publicly update or revise any forward-looking statements.
Brent Larson, 614-822-2330
Sr. VP & CFO
Makovsky + Company
Gene Marbach, 212-508-9645
KEYWORDS: United States North America Ohio
INDUSTRY KEYWORDS: Surgery Health Biotechnology Medical Devices Oncology Pharmaceutical Other Health FDA Medical Supplies General Health