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Navidea Announces Scientific Presentations of Results from Lymphoseek® Studies at the European Association of Nuclear Medicine and European Society of Surgical Oncology MeetingsDUBLIN, Ohio --(Business Wire)-- Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) today announced that data and results from its Lymphoseek® (technetium Tc 99m tilmanocept) injection studies in breast cancer, melanoma or head and neck cancer were recently presented at the European Association of Nuclear Medicine Congress in Gothenberg, Sweden and will be presented this week at the European Society of Surgical Oncology-British Association of Surgical Oncology Congress from October 29-31, 2014 in Liverpool, UK. "Following our recent positive opinion by the Committee for Medicinal Products for Human Use (CHMP) and the anticipated approval by the European Commission later this year, we are pleased to share these exciting Lymphoseek results with the European medical community," said Rick Gonzalez, Navidea Chief Executive Officer. "We believe the targeted technology of Lymphoseek is an advance in the reliable and accurate location of sentinel lymph nodes aiding more effective cancer staging and better informing post-surgical treatment. Taken together with this month's U.S. FDA approval for lymphatic mapping in all solid tumors, momentum continues to build toward our primary goal of making Lymphoseek the global standard of care in lymphatic mapping." Details of the presentations by Navidea and its collaborators are listed below.
The presentations showed positive and consistent results from Lymphoseek's three pivotal prospective Phase 3 studies in melanoma, breast cancer, and certain head and neck cancers and included associated analysis of the combined data from more than 500 subjects. All three studies showed positive diagnostic performance of Lymphoseek across the solid tumor types studied. To date, no clinically significant drug-related adverse reactions have been reported. Lymphoseek has no contraindications and the most common adverse reactions were injection site irritation and/or pain (<1%).
About Lymphoseek Lymphoseek has also been recommended by CHMP for European approval for the following indication:
Accurate diagnostic evaluation of cancer is critical, as it guides therapy decisions and determines patient prognosis and risk of recurrence. Overall in the U.S., solid tumor cancers may represent up to 1.2 million cases per year. The sentinel node label in the U.S. and Europe may address approximately 235,000 new cases of breast cancer, 76,000 new cases of melanoma and 45,000 new cases of head and neck/oral cancer in the U.S., and approximately 367,000 new cases of breast cancer, 83,000 new cases of melanoma and 55,000 new cases of head and neck/oral cancer diagnosed in Europe annually.
U.S. Lymphoseek Indication and Important Safety Information
Important Safety Information Prior to the administration of Lymphoseek, patients should be asked about previous hypersensitivity reactions to drugs, in particular dextran and modified forms of dextran. Resuscitation equipment and trained personnel should be available at the time of Lymphoseek administration, and patients observed for signs or symptoms of hypersensitivity following injection. Any radiation-emitting product may increase the risk for cancer. Adhere to dose recommendations and ensure safe handling to minimize the risk for excessive radiation exposure to patients or health care workers. In clinical trials, no patients experienced serious adverse reactions and the most common adverse reactions were injection site irritation and/or pain (<1%).
FULL LYMPHOSEEK PRESCRIBING INFORMATION CAN BE FOUND AT:
About Navidea Biopharmaceuticals Inc. The Private Securities Litigation Reform Act of 1995 (the Act) provides a safe harbor for forward-looking statements made by or on behalf of the Company. 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 within the meaning of the Act. 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-K and other Securities and Exchange Commission filings. The Company undertakes no obligation to publicly update or revise any forward-looking statements.
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