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Neoprobe Receives Regulatory Clearance for Lymphoseek Clinical Study; Lymphoseek Trial Removed From FDA Clinical Hold

Posted on: Thursday, 11 May 2006, 18:02 CDT

Neoprobe Corporation (OTCBB:NEOP), a diversified developer of innovative oncology and cardiovascular surgical and diagnostic products, today announced that Neoprobe has been granted authorization by FDA to commence patient enrollment in a Phase 2 multi-center clinical study to evaluate the safety and efficacy of Lymphoseek(TM), a lymphatic tissue targeting agent being developed by the Company. The authorization to commence enrollment follows FDA's review of Neoprobe's responses to information requested by FDA in response to prior submissions by the Company regarding the chemistry, manufacturing and control and non-clinical testing of Lymphoseek. Neoprobe intends to enroll up to eighty patients at five of the leading cancer treatment centers in the United States under the amended Phase 2 clinical protocol. Lymphoseek is intended to be used in biopsy procedures for the detection of lymph nodes in breast and melanoma cancer patients.

Dr. Richard Orahood, Neoprobe's Medical Director, said, "To date, the clinical and preclinical results that have been completed demonstrate the benefits of Lymphoseek. We believe the safety and efficacy of Lymphoseek will be further supported by the completion of multi-center studies. In preparation for the initiation of the Phase 2 clinical study, Neoprobe met with the Phase 2 investigators at the Society of Surgical Oncology meeting in late March. We expect to begin patient enrollment in the Phase 2 clinical study sometime in June after the FDA-approved clinical protocol and associated materials receive final clearance from review committees of the investigational sites."

About Neoprobe

Neoprobe develops and provides innovative surgical and diagnostic products that enhance patient care by meeting the critical decision making needs of healthcare professionals. Neoprobe currently markets the neo2000(R) line of gamma detection systems that are widely used by cancer surgeons for intraoperative lymphatic mapping and the Quantix(R) line of blood flow measurement products that are designed to be used by cardiovascular surgeons, neurosurgeons and critical care physicians. In addition, Neoprobe holds significant interests in the development of related biomedical systems and agents including Lymphoseek(TM) and RIGScan(R) CR. Lymphoseek is an investigational drug being developed as a lymphatic tracing agent. The RIGS(R) system is an investigational technology that combines the Company's gamma detection device technology with a proprietary disease-specific radiolabeled cancer targeting agent that is injected into a cancer patient prior to their surgery, and a patented surgical method to get real-time information to locate tumor deposits that may not be detectable by conventional methods. The Company'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 product, 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.

Source: Business Wire

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