DUBLIN, Ohio–(BUSINESS WIRE)–Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), appear a advertisement in Nuclear Medicine and Biology, the official account of the Society of Radiopharmaceutical Sciences, which describes the analytic bond amid immunodiagnostic and immunotherapeutic agents. This action is exemplified by the self-transforming attributes of Navidea’s Manocept™ immunotargeting belvedere which provides aerial specificity adjoin receptor-bearing targets and is a able access to immunotherapy.
The aboriginal artefact of the Manocept platform, Lymphoseek® (technetium Tc 99m tilmanocept) bang was launched as a atypical immunodiagnostic abettor accustomed by the FDA and acclimated in , melanoma and articulate atrium blight bouncer lymph bulge biopsy (SLNB) procedures. Lymphoseekhas accustomed its capability through abounding evidence-based studies in SLNB, due to its different anatomy and targeting of CD206 begin on macrophages in tumor-draining lymph nodes. Its Manocept backbone, enabled by the adeptness to altering radionuclides for biological modifier molecules, has the abeyant to ambition macrophage-mediated diseases and bear an effective, accurately targeted biologic for purposes of ache analysis and abbreviation or eliminating ancillary effects.
“Past ameliorative strategies attempting to accouter the ability of the allowed arrangement to manage, amusement or annihilate macrophages in ache states like blight and anarchic altitude accept had bound to no success,” said Michael S. McGrath, M.D., Ph.D., Professor, Departments of Laboratory Medicine, Pathology, and Medicine at the University of California, San Francisco (UCSF). “The Manocept belvedere possesses a different abeyant to not alone ambition abnormal macrophages for apprehension or analysis but additionally bouncer non-affected cells, which could greatly abode ample unmet needs for patients both diagnostically and therapeutically.”
“These anew appear after-effects highlight the arresting specificity and acuteness of the Manocept platform, and its bendability which acquiesce it to accomplishment the accustomed history of macrophage-mediated diseases,” said Frederick O. Cope, Ph.D., M.S., FACN, Navidea’s Chief Scientific Officer. “It is attenuate to acquisition a belvedere that selectively targets activated macrophages, which are axial to the allowed system. These after-effects accommodate added validation of the Manocept platform, as we abide to body a activity of added immunodiagnostic and immunotherapeutic articles beyond oncology, anarchic and communicable diseases.”
Summary of After-effects
A alternation of studies accurate by accommodating acknowledgment to immunodiagnostic imaging drug, targeting studies, accommodating explant studies, and in vivo and ex vivo beastly abstracts advised Manocept agents including 99mTc-tilmanocept, Cy3-tilmanocept, and Manocept-doxorubicin. These studies accurate the self-transforming attributes of the Manocept belvedere from immunodiagnostic imaging to able Manocept ameliorative targeting. Abstracts from studies in several macrophage-mediated diseases including Kaposi’s sarcoma, rheumatoid arthritis, and cardiovascular ache appearance that Manocept belvedere compounds bind about alone to animal macrophages and that the mannose receptor (CD206) is the aloft receptor for its recognition. For complete capacity of the studies, allegation and results, “The Inextricable Axis of Targeted Analytic Imaging And Therapy: An Immunological Accustomed History Approach” appears in the March 2016 book account Nuclear Medicine and Biology. 2016 Nuclear Medicine and Biology. Volume 43, Issue 3, Pages 215–225. [doi: 10.1016/j.nucmedbio.2015.11.007].
Lymphoseek® (technetium Tc 99m tilmanocept) bang is the aboriginal and alone FDA-approved receptor-targeted aqueous mapping agent. It is a novel, receptor-targeted, small-molecule radiopharmaceutical acclimated in the appraisal of aqueous basins that may accept blight captivation in patients. Lymphoseek is advised for the absolute identification of lymph nodes that cesspool from a primary tumor, which accept the accomplished anticipation of harboring cancer. Lymphoseek is accustomed by the U.S. Food and Biologic Administering (FDA) for use in solid bump cancers area aqueous mapping is a basic of surgical administering and for allegorical bouncer lymph bulge biopsy in patients with clinically bulge abrogating cancer, melanoma or squamous corpuscle blight of the articulate cavity. Lymphoseek has additionally accustomed European approval in imaging and intraoperative apprehension of bouncer lymph nodes in patients with melanoma, blight or localized squamous corpuscle blight of the articulate cavity.
Accurate analytic appraisal of blight is critical, as after-effects adviser analysis decisions and actuate accommodating cast and accident of recurrence. Overall in the U.S., solid bump cancers may represent up to 1.2 actor cases per year. The bouncer bulge characterization in the U.S. and Europe may abode about 600,000 new cases of cancer, 160,000 new cases of melanoma and 100,000 new cases of arch and neck/oral blight diagnosed annually.
Lymphoseek Indication and Important Safety Advice
Lymphoseek is a radioactive analytic abettor adumbrated with or after scintigraphic imaging for:
Important Safety Advice
In analytic trials with Lymphoseek, no austere hypersensitivity reactions were reported, about Lymphoseek may affectation a accident of such reactions due to its actinic affinity to dextran. Austere hypersensitivity reactions accept been associated with dextran and adapted forms of dextran (such as adamant dextran drugs).
Prior to the administering of Lymphoseek, patients should be asked about antecedent hypersensitivity reactions to drugs, in accurate dextran and adapted forms of dextran. Resuscitation accessories and accomplished cadre should be accessible at the time of Lymphoseek administration, and patients empiric for signs or affection of hypersensitivity afterward injection.
Any radiation-emitting artefact may access the accident for cancer. Adhere to dosage recommendations and ensure safe administration to abbreviate the accident for boundless radiation acknowledgment to patients or bloom affliction workers.
In analytic trials, no patients accomplished austere adverse reactions and the best accepted adverse reactions were bang armpit affliction and/or affliction (<1%).
FULL LYMPHOSEEK PRESCRIBING INFORMATION CAN BE FOUND AT: WWW.LYMPHOSEEK.COM
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) is a biopharmaceutical aggregation focused on the development and commercialization of attention immunodiagnostic agents and immunotherapeutics. Navidea is developing assorted precision-targeted articles and platforms including Manocept™ and NAV4694 to advice analyze the sites and pathways of undetected ache and accredit bigger analytic accuracy, analytic decision-making, targeted analysis and, ultimately, accommodating care. Lymphoseek® (technetium Tc 99m tilmanocept) injection, Navidea’s aboriginal bartering artefact from the Manocept platform, was accustomed by the FDA in March 2013 and in Europe in November 2014. The development activities of the Manocept immunotherapeutic belvedere will be conducted by Navidea in affiliation with its subsidiary, Macrophage Therapeutics. Navidea’s action is to bear aloft advance and actor acknowledgment by bringing to bazaar atypical articles and advancing the Company’s activity through all-around partnering and commercialization efforts. For added information, amuse appointment www.navidea.com.
The Private Securities Litigation Reform Act of 1995 (the Act) provides a safe anchorage for advanced statements fabricated by or on account of the Company. Statements in this account release, which chronicle to added than carefully absolute facts, such as statements about the Company’s affairs and strategies, expectations for approaching banking performance, new and absolute articles and technologies, advancing analytic and authoritative pathways, and markets for the Company’s articles are advanced statements aural the acceptation of the Act. The words “believe,” “expect,” “anticipate,” “estimate,” “project,” and agnate expressions analyze advanced statements that allege alone as of the date hereof. Investors are cautioned that such statements absorb risks and uncertainties that could account absolute after-effects to alter materially from absolute or advancing after-effects due to abounding factors including, but not bound to, the Company’s continuing operating losses, ambiguity of bazaar accepting of its products, assurance on third affair manufacturers, accumulated deficit, approaching basic needs, ambiguity of basic funding, assurance on bound artefact band and administration channels, competition, bound business and accomplishment experience, risks of development of new products, authoritative risks and added risks abundant in the Company’s best contempo Annual Report on Form 10-K and added Securities and Exchange Commission filings. The Aggregation undertakes no obligation to about amend or alter any advanced statements.
The advice declared aloft was able by Navidea Biopharmaceuticals, Inc. and reflects alone the assessment of the corporation. Nothing in this account shall be construed to betoken any abutment or endorsement of Navidea, or any of its products, by The Regents of the University of California, its officers, agents and employees.
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