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Navidea Awarded $1.7 Million Fast Track NIH SBIR Grant for Evaluation of Manocept™ in Rheumatoid ArthritisNavidea announces the receipt of an initial notice of award for a Fast Track Small Business Innovation Research (SBIR) grant providing for up to $1.7 million from the National Institutes of Health's (NIH) National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMD), to fund preclinical animal studies and a Phase 1/2 human clinical study examining the ability of Tc 99m-tilmanocept, a Manocept™ platform product, to identify skeletal joints that are inflamed due to rheumatoid arthritis (RA). RA is a chronic, progressive, systemic autoimmune disease characterized by inflammation of numerous skeletal joints. If not treated successfully, RA can lead to disability, disfigurement and premature death. The funds for this Fast Track grant will be released in two parts, which together have the potential to provide a total of $1.7 million in resources over 2.5 years to achieve the specific aims and objectives of the grant. The first part will provide $225,000 to support preclinical animal studies and to support activities needed to prepare for the Phase 1/2 clinical study. The second part of the award will support the Phase 1/2 study, the results from which are expected to confirm the safety and effectiveness of Tc 99m-tilmanocept to identify skeletal joint inflammation due to RA. "Because the therapies for RA are most effective when given early in the course of the illness, improved ability for accurate, early diagnosis along with more accurate monitoring of therapies could lead to improved patient outcomes," commented Michael Tomblyn, M.D., Navidea's Chief Medical Officer. "This grant will, as a follow on to other successful pre-clinical work, enable human evaluation for the first time of the IV administration of tilmanocept to identify peripheral skeletal joints that are inflamed as a result of ongoing RA pathology and to differentiate RA from osteoarthritis patients." "Developing future medical applications which unlock the potential for our CD206-targeting imaging agent, tilmanocept, is a corporate priority," said Frederick O. Cope, Ph.D., FACS, Chief Scientific Officer of Navidea. These studies will broaden the use of the Manocept platform to other potential macrophage-associated diseases and will evaluate a new approach to tilmanocept delivery with future implications in therapeutic development.
About the Phase 1/2 Clinical Study Efforts
Updates on Additional SBIR Grants
About Rheumatoid Arthritis
About the Manocept&trad; CD206-targeting platform
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. 1 Helmick CG, Felson DT, Lawrence RC, et al. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States- Part I. Arthritis & Rheum. 2008: 58(1):15-25. Information available at http://www.rheumatology.org/ACR/about/newsroom/prevalence/prevalence-one.pdf View source version on businesswire.com: http://www.businesswire.com/news/home/20150729005400/en/ |