FDA Panel Recommends Navy's Proposed 'RESUS' Phase IIb/III Trauma Trial Not Proceed As Designed; Suggests Phase II Study
The recommendation, which is not binding on the FDA, came after a day-long hearing yesterday at which the Naval Medical Research Center (NMRC), which is sponsoring RESUS, and the FDA explained the study's design and discussed preclinical and clinical data. During its deliberations, the committee questioned whether existing data justify a Phase III trial to be conducted under the federal regulation (21 CFR 50.24) allowing for exception to informed consent in patients who are unable to provide adequate consent given the nature of their injuries.
"Although the committee advised against RESUS moving forward, we view its comments today as constructive criticism and generally supportive of the product's development for the emergency pre-hospital treatment of trauma patients," said Biopure Chairman and CEO Zafirelis G. Zafirelis.
Biopure Corporation develops, manufactures and markets pharmaceuticals, called oxygen therapeutics, that are intravenously administered to deliver oxygen to the body's tissues. Hemopure(R) [hemoglobin glutamer - 250 (bovine)], or HBOC-201, is approved for sale in South Africa for the treatment of surgical patients who are acutely anemic. Biopure has applied in the United Kingdom for regulatory approval of a proposed orthopedic surgical anemia indication. The company is developing Hemopure for a potential indication in cardiovascular ischemia, in addition to supporting the U.S. Navy's government-funded efforts to develop a potential out-of-hospital trauma indication. Biopure's veterinary product Oxyglobin(R) [hemoglobin glutamer - 200 (bovine)], or HBOC-301, the only oxygen therapeutic approved by the U.S. Food and Drug Administration and the European Commission, is indicated for the treatment of anemia in dogs.
Statements in this press release that are not strictly historical are forward-looking statements, including any that might imply that the proposed RESUS trauma trial will receive authorization to proceed. Actual results and their timing may differ materially from those projected in these forward-looking statements due to risks and uncertainties. These risks include, without limitation, uncertainties regarding the company's financial position, unexpected costs and expenses, delays and determinations by regulatory authorities, and delays in or unpredictable outcomes of clinical trials. The company undertakes no obligation to release publicly the results of any revisions to these forward-looking statements to reflect events or circumstances arising after the date hereof. A full discussion of the company's operations and financial condition can be found in the company's filings with the U.S. Securities and Exchange Commission, including under the heading "Risk Factors" in the Form 10-Q filed on September 11, 2006, which can be accessed in the EDGAR database at the SEC Web site, http://www.sec.gov.
The content of this press release does not necessarily reflect the position or the policy of the U.S. Government or the Department of Defense, and no official endorsement should be inferred.
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24 Mar. 2017. <http://www.medicalnewstoday.com/releases/59185.php>
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