Healthcare Industry News: Neoprobe
News Release - September 10, 2007
Neoprobe Provides Updated Phase 2 Clinical Data for Lymphoseek(R)
Phase 2 Achieved Clinical ObjectivesDUBLIN, Ohio--(HSMN NewsFeed)--Neoprobe Corporation (OTCBB:NEOP ), a diversified developer of innovative oncology and cardiovascular surgical and diagnostic products, today provided updated information from its multi-center Phase 2 clinical evaluation of Lymphoseek. The Phase 2 clinical study was conducted at five leading cancer centers in patients with either melanoma or breast cancer. A total of eighty patients were enrolled in the study. The primary objective of the study was to demonstrate that Lymphoseek accurately identified the lymph node in at least 90% of the evaluable patients. An overall lymph node identification rate of 95% was achieved in the study.
In addition, the pathology examination of the lymph nodes identified by Lymphoseek confirmed the presence of tumor cells in 23% of the breast cancer patients evaluated and in 22% of the melanoma patients evaluated. No significant adverse events attributed to Lymphoseek were observed in the study.
David Bupp, Neoprobe President and CEO, said "we are very pleased to provide additional data from the successful Phase 2 study. The study objectives were exceeded and the pathology staging of patients using Lymphoseek is concordant with published medical literature regarding sentinel lymph node biopsy. The successful completion of the Phase 2 study provides us with an increasing sense of confidence that we will be able to meet the clinical objectives of our proposed Phase 3 studies of Lymphoseek. We have commenced activities in preparation for the initiation of the Phase 3 studies including providing a request to FDA for a meeting to review and discuss the Phase 3 study designs."
Lymphoseek is a proprietary radioactive tracing agent being developed for use in connection with gamma detection devices in a surgical procedure known as Intraoperative Lymphatic Mapping (ILM). Neoprobe has filed Phase 2 information with FDA. Neoprobe intends to discuss with FDA protocols for the conduct of Phase 3 clinical evaluations of Lymphoseek in patients with either breast cancer or melanoma. Pending the completion of the Phase 3 protocol review with FDA and obtaining the consent of the institutions who will conduct the Phase 3 studies, Neoprobe intends to commence enrollment in the Phase 3 trials before year end 2007.
About Neoprobe
Neoprobe 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 neo2000® line of gamma detection systems that are widely used by cancer surgeons and is commercializing the Quantix® line of blood flow measurement products developed by its subsidiary, Cardiosonix Ltd. In addition, Neoprobe holds significant interests in the development of related biomedical systems and radiopharmaceutical agents including Lymphoseek® and RIGScan® CR. 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.
Source: Neoprobe
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