DUBLIN, Ohio--(BUSINESS WIRE)--Neoprobe Corporation (OTCBB: NEOP), a diversified developer of innovative oncology surgical and diagnostic products, today announced that researchers who participated in the breast cancer arm of a Phase 3 clinical evaluation of Lymphoseek® presented data from their clinical experience at the International San Antonio Breast Cancer Symposium. The Phase 3 study referenced in the presentation was conducted in patients with either breast cancer or melanoma. The San Antonio presentation provided information on the breast cancer portion of the trial. Earlier this year, Neoprobe announced that the trial evaluated 130 procedure-compliant patients. The breast cancer arm of the trial contributed 60 patients.
The Phase 3 trial was designed to determine the accuracy of Lymphoseek to identify lymphatic tissue as compared to a commonly used vital blue dye. The primary objective of the Phase 3 trial was to obtain at least 203 lymph nodes identified with the vital blue dyes and to statistically demonstrate that 94% of those nodes were identified with Lymphoseek. The procedure-compliant patients contributed 215 vital blue dye positive lymph nodes and Lymphoseek identified 210 of those nodes for a success rate of 97%. In addition, Lymphoseek identified 85 lymph nodes that were missed by the vital blue dyes. Of those Lymphoseek-only positive nodes, 18% were found to contain tumor.
“We are very pleased by the positive audited data of the Phase 3 clinical trial for Lymphoseek in both breast cancer and melanoma patients,” said Dr. Frederick Cope, Neoprobe’s Vice President, Pharmaceutical Research and Clinical Development. “The results of the Phase 3 trial have been provided to FDA and we believe if Lymphoseek is ultimately cleared for marketing that it will provide meaningful improvement in the treatment of cancer patients.”
Results of the breast cancer portion of the Phase 3 trial mirrored the overall results. The breast cancer patients provided 97 vital blue dye positive lymph nodes and 93 of those nodes were positive for Lymphoseek. The concordant detection rate of lymph nodes in breast cancer patients was 96%. In addition, Lymphoseek identified 49 lymph nodes in the breast cancer patients that were missed by the vital blue dyes. Of those Lymphoseek-only positive nodes, 10% were found by pathology to contain tumor. No drug-related adverse events were reported that were attributed to Lymphoseek.
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 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® 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.
Contact:
Neoprobe CorporationBrent Larson, 614-822-2330Vice President / CFOorThe Shoreham GroupTim Ryan, 212-242-7777
