Navidea and Massachusetts General Hospital to Evaluate Manocept™ for Detection of Cardiovascular Disease with NIH Grant

DUBLIN, Ohio,  Navidea Biopharmaceuticals, Inc., 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
Recently, it has been observed that CD206 expressing macrophages densely populate vulnerable plaques or thin cap fibroatheromas (TCFA) but not other kinds (i.e., stable) of atherosclerotic plaques. A primary goal for this grant involves an approved clinical investigation of up to 18 individuals with and without aortic and high risk coronary atherosclerotic plaques and with and without HIV infection to determine the feasibility of 99mTc-tilmanocept to image high risk plaque by SPECT/CT. Results have the potential to provide evidence of the potential of 99mTc-tilmanocept to accumulate in high risk morphology plaques, the ability to make preliminary comparisons of aortic 99mTc-tilmanocept uptake by SPECT/CT in each group, and to evaluate the ability of 99mTc-tilmanocept to identify the same aortic atherosclerotic plaques that are identified by contrast enhanced coronary computed tomography angiography (CCTA) and/or PET/CT.

About Atherosclerosis
Atherosclerosis is a chronic, progressive inflammatory condition resulting, over the course of years or decades, in the formation of atherosclerotic plaques in the walls of arteries. Atherosclerosis is the underlying pathology in the majority of cases of cardiovascular disease (CVD) and a significant proportion of cases of stroke. CVD and stroke are the first and fourth leading causes of mortality in the US, respectively. Persons with advanced atherosclerosis are frequently asymptomatic until one of their atherosclerotic plaques ruptures, leading to blood clot formation, which restricts blood flow to tissues. By this mechanism, rupture of atherosclerotic plaques causes myocardial infarctions, sudden cardiac deaths and strokes.

About Lymphoseek
Lymphoseek^® (technetium Tc 99m tilmanocept) injection is the first and only FDA-approved receptor-targeted lymphatic mapping agent. It is a novel, receptor-targeted, small-molecule radiopharmaceutical used in the evaluation of lymphatic basins that may have cancer involvement in patients. Lymphoseek is designed for the precise identification of lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer. Lymphoseek is approved by the U.S. Food and Drug Administration (FDA) for use in solid tumor cancers where lymphatic mapping is a component of surgical management and for guiding sentinel lymph node biopsy in patients with clinically node negative breast cancer, melanoma or squamous cell carcinoma of the oral cavity. Lymphoseek has also received European approval in imaging and intraoperative detection of sentinel lymph nodes in patients with melanoma, breast cancer or localized squamous cell carcinoma of the oral cavity.

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.

Source: Navidea