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Navidea and Massachusetts General Hospital to Evaluate Manocept™ for Detection of Cardiovascular Disease with NIH GrantNavidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), is announcing the receipt of a notice of award for a Phase 1 Small Business Innovation Research (SBIR) grant providing $321K from the National Heart Lung and Blood Institute (NHLBI), National Institutes of Health (NIH). The study, to be done in collaboration with Massachusetts General Hospital (MGH) and Harvard Medical School, will examine the ability of Tc 99m-tilmanocept, a Manocept™ platform product, to localize in high-risk atherosclerotic plaques. These specific plaques are rich in CD206 expressing macrophages and are at high-risk for near term rupture resulting in myocardial infarctions, sudden cardiac death and strokes, accumulatively the leading cause of death in the US. The consequences of atherosclerosis and the cardiovascular disease (CVD) that atherosclerosis causes, while severe in all populations of people, are particularly concentrated in HIV+ patients. "This Phase 1 pilot study may provide evidence that Tc99m-tilmanocept localizes in atherosclerotic plaques which would enable potential development of a diagnostic imaging agent that could benefit not only HIV+ patients but millions of people," said Michael Tomblyn, M.D., Navidea's Chief Medical Officer. "Positive outcomes would also support our Manocept development vision of a larger program that seeks to evaluate tilmanocept as a targeting vehicle to deliver therapies intended to limit or reverse atherosclerosis directly to plaques that could reduce cardiovascular disease (CVD) risk and improve outcomes for this patient population." "HIV infected patients suffer disproportionally from atherosclerosis and CVD," commented Steven Grinspoon, M.D., Professor of Medicine at Harvard Medical School, Director MGH Program in Nutritional Metabolism, Co-Director of the Nutrition Obesity Research Center at Harvard and the study's lead investigator. "There exists a profound and highly significant unmet need for means to better diagnose and treat atherosclerosis in all patients but particularly so in HIV patients. Manocept's proven specificity for CD206 presents a clinically exploitable target with potential to achieve significant diagnostic and therapeutic results where few other approaches have progressed."
About the Phase 1 SBIR Clinical Study
About Atherosclerosis
About Lymphoseek 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.
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: WWW.LYMPHOSEEK.COM.
About Navidea 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. Resources:
1. Burke AP, Virmani R. Pathophysiology of acute myocardial infarction.
Med Clin North Am. 2007 Jul;91(4):553-72; ix. PMID: 17640536 View source version on businesswire.com: http://www.businesswire.com/news/home/20150728005557/en/ |