![](http://investorshub.advfn.com/images/default_ih_profile2_4848.jpg?cb=0)
Friday, October 09, 2020 8:42:45 AM
Fri, October 9, 2020, 7:30 AM
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced that the American College of Rheumatology ("ACR") has accepted the results from the Company’s second interim analysis of its ongoing NAV3-31 Phase 2b clinical study for presentation at the ACR Annual Meeting ("ACR Convergence 2020") under the title, "Tc99m Tilmanocept Imaging Is an Early Predictor of Clinical Response in Rheumatoid Arthritis Patients Beginning New Anti-TNFa Therapy."
This year’s annual meeting will be conducted as a virtual conference from November 5-9, 2020. Navidea’s abstract is accessible online at acrabstracts.org, abstract number 1544, with presentation of the poster on Monday, November 9, 2020 from 9:00 am – 11:00 am Eastern. The poster abstract will also be published in an online supplement of the journal Arthritis & Rheumatology.
Navidea’s NAV3-31 Phase 2b trial titled "Evaluation of the Precision and Sensitivity of Tilmanocept Uptake Value (TUV) on Tc99m Tilmanocept Planar Imaging" has three arms: Arm 1 consists of healthy subjects, Arm 2 is comprised of patients with active, moderate-to-severe rheumatoid arthritis ("RA") who are on stable therapy, and Arm 3 is a pilot arm of the upcoming Phase 3 trial assessing the ability of Tc99m tilmanocept to provide an early indicator of efficacy of anti-tumor necrosis factor ("TNF") alpha treatment in RA patients.
This second interim analysis was designed to examine data from Arm 3 of the study in order to evaluate the magnitude of change of Tc99m tilmanocept signal localized to RA-involved joints in patients before and after treatment with an anti-TNF alpha therapy as well as to examine whether this change in localization, if any, can serve as an early, quantifiable predictor of treatment efficacy.
A total of 15 subjects with active moderate-to-severe RA were included in this interim analysis, each of whom were set to begin a new or first-time treatment regimen with an anti-TNF alpha therapy. Whole body and hand/wrist planar gamma camera images were obtained at baseline prior to initiation of new treatment, again at 5 weeks post therapy initiation, and then again at 12 weeks on 11 of the 15 subjects at the time of this analysis. A panel of established clinical assessments was performed at each time point as well, in order to compare imaging results with clinical standards over the 12-week time course. Results of the preliminary analysis demonstrated:
- Tc99m tilmanocept imaging from baseline to week 5 was predictive of clinical outcome at 12 weeks in 9 out of 11 subjects with 12-week clinical assessment available at the time of the interim analysis.
- Combined data from all 15 subjects in Arm 3 suggest a wide dynamic range of more than one order of magnitude (>10-fold) for calculated global Tc99m tilmanocept uptake values in joints with RA-involved inflammation.
- The wide dynamic range of global Tc99m tilmanocept signal readout combined with the low variability of imaging signal quantification established in Arms 1 and 2 of this trial are supportive of the idea that clinically meaningful changes in signal localization can be detected.
- These preliminary results indicate that marked changes in Tc99m tilmanocept global uptake values by week 5 presage clinical efficacy evaluations at week 12 of treatment.
Dr. Michael Rosol, Chief Medical Officer for Navidea, said, "We are delighted by the recognition of the importance of our Phase 2b interim results by the ACR Convergence 2020 scientific committee and the opportunity to present our results at this internationally recognized meeting." Dr. Rosol continued, "This is the type of external validation of our work that reflects the great medical need for a robust, objective, noninvasive means of assessing inflammation in RA-involved joints. It is our expectation that Tc99m tilmanocept can address this need and provide critical information for rheumatologists to put their patients on the correct therapeutic pathway earlier than is currently possible."
Jed Latkin, Navidea’s Chief Executive Officer, said, "It’s a great honor that our clinical trial results in RA have been regularly accepted for presentation at international meetings the last several years, and this acceptance by ACR continues that record of success."
RA is a chronic disease affecting over 1.3 million Americans and as much as 1% of the worldwide population1. If the product is successfully developed, Navidea would expect to play a major role in the management of RA patients worldwide.
1. https://www.rheumatoidarthritis.org/ra/facts-and-statistics/
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) is a biopharmaceutical company focused on the development of precision immunodiagnostic agents and immunotherapeutics. Navidea is developing multiple precision-targeted products based on its Manocept™ platform to enhance patient care by identifying the sites and pathways of disease and enable better diagnostic accuracy, clinical decision-making, and targeted treatment. Navidea’s Manocept platform is predicated on the ability to specifically target the CD206 mannose receptor expressed on activated macrophages. The Manocept platform serves as the molecular backbone of Tc99m tilmanocept, the first product developed and commercialized by Navidea based on the platform. Navidea’s strategy is to deliver superior growth and shareholder return by bringing to market novel products and advancing the Company’s pipeline through global partnering and commercialization efforts. For more information, please visit http://www.navidea.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends affecting the financial condition of our business. Forward-looking statements include our expectations regarding pending litigation and other matters. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: our history of operating losses and uncertainty of future profitability; the final outcome of any pending litigation; our ability to successfully complete research and further development of our drug candidates; the timing, cost and uncertainty of obtaining regulatory approvals of our drug candidates; our ability to successfully commercialize our drug candidates; dependence on royalties and grant revenue; our ability to implement our growth strategy; anticipated trends in our business; our limited product line and distribution channels; advances in technologies and development of new competitive products; our ability to comply with the NYSE American continued listing standards; our ability to maintain effective internal control over financial reporting; the impact of the current coronavirus pandemic; and other risk factors detailed in our most recent Annual Report on Form 10-K and other SEC filings. You are urged to carefully review and consider the disclosures found in our SEC filings, which are available at www.sec.gov or at http://ir.navidea.com.
Investors are urged to consider statements that include the words "will," "may," "could," "should," "plan," "continue," "designed," "goal," "forecast," "future," "believe," "intend," "expect," "anticipate," "estimate," "project," and similar expressions, as well as the negatives of those words or other comparable words, to be uncertain forward-looking statements.
You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be incorrect. We undertake no obligation to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this report. In light of these risks and uncertainties, the forward-looking events and circumstances discussed in this report may not occur and actual results could differ materially from those anticipated or implied in the forward-looking statements.
References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Navidea is not responsible for the contents of third-party websites.
View source version on businesswire.com: https://www.businesswire.com/news/home/20201009005074/en/
Contacts
Navidea Biopharmaceuticals, Inc.
Jed Latkin, CEO
614-973-7490
mailto://jlatkin@navidea.com
Joel Kaufman
Head of Strategy and Business Development
614-822-2372
mailto://jkaufman@navidea.com
Recent NAVB News
- Form SC 13D/A - General statement of acquisition of beneficial ownership: [Amend] • Edgar (US Regulatory) • 12/21/2023 08:32:18 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/05/2023 11:26:20 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/01/2023 04:49:54 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/16/2023 09:55:52 PM
- Form 25-NSE - Notification filed by national security exchange to report the removal from listing and registration of matured, redeemed or retired securities • Edgar (US Regulatory) • 10/23/2023 05:56:24 PM
- Navidea Biopharmaceuticals, Inc. Announces NYSE American’s Decision to Suspend Trading In Its Common Stock • Business Wire • 10/06/2023 01:01:00 AM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 10/05/2023 08:21:49 PM
- Form PRE 14A - Other preliminary proxy statements • Edgar (US Regulatory) • 09/15/2023 07:42:35 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 09/11/2023 04:15:30 AM
- Form 3 - Initial statement of beneficial ownership of securities • Edgar (US Regulatory) • 08/15/2023 09:53:39 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/11/2023 08:06:00 PM
- Navidea Biopharmaceuticals, Inc. NAVB Requests Oral Hearing With NYSE Hearing Panel • Business Wire • 08/10/2023 01:29:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/08/2023 08:23:49 PM
- Navidea Biopharmaceuticals, Inc. Presses Ahead, Embraces Opportunities • Business Wire • 07/31/2023 01:32:00 PM
- Navidea Biopharmaceuticals, Inc. Announces NYSE American Has Commenced Delisting Proceedings and Intent to Appeal NYSE American Determination • Business Wire • 07/29/2023 12:23:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/28/2023 09:10:53 PM
- Navidea Biopharmaceuticals, Inc. Hires Craig A. Dais, CPA as Chief Financial Officer • Business Wire • 07/27/2023 09:20:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/17/2023 10:02:51 PM
- Form 3 - Initial statement of beneficial ownership of securities • Edgar (US Regulatory) • 07/17/2023 10:00:44 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/13/2023 09:27:36 PM
- Navidea Biopharmaceuticals, Inc. Welcomes Dana J Moss, JD to Board of Directors; Amit Bhalla Steps Down • Business Wire • 07/13/2023 09:09:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/06/2023 08:39:03 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 07/03/2023 09:30:38 PM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 07/03/2023 08:01:04 PM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 06/30/2023 08:01:34 PM
Bantec's Howco Short Term Department of Defense Contract Wins Will Exceed $1,100,000 for the current Quarter • BANT • Jun 25, 2024 10:00 AM
ECGI Holdings Targets $9.7 Billion Equestrian Apparel Market with Allon Brand Launch • ECGI • Jun 25, 2024 8:36 AM
Avant Technologies Addresses Progress on AI Supercomputer-Driven Data Centers • AVAI • Jun 25, 2024 8:00 AM
Green Leaf Innovations, Inc. Expands International Presence with New Partnership in Dubai • GRLF • Jun 24, 2024 8:30 AM
Bemax Inc. Positions to Capitalize on Industry Growth with New Improved Quality of Mother's Touch® Disposable Diapers • BMXC • Jun 24, 2024 8:00 AM
Last Shot Hydration Drink Announced as Official Sponsor of Red River Athletic Conference • EQLB • Jun 20, 2024 2:38 PM