Statement of Northfield Laboratories Regarding Its Pivotal Phase III Trial.EVANSTON, Ill. -- Please replace the release with the following corrected version due to multiple revisions. The corrected release reads: STATEMENT OF NORTHFIELD LABORATORIES REGARDING ITS PIVOTAL PHASE III TRIAL Northfield Laboratories (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : NFLD NFLD Newfoundland ) released the following statement today in response to news reports that Senator Charles Grassley (R-Iowa) has raised questions about the Northfield trauma trial research protocol: The status of the Company's Pivotal Phase III trial is unchanged. Northfield is committed to assuring that the study is performed in accordance with all applicable regulations, with FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. and IRB IRB See: Industrial Revenue Bond oversight, and with the utmost concern for patient safety. The independent data monitoring committee (IDMC IDMC Internal Displacement Monitoring Centre IDMC Independent Data Monitoring Committee IDMC International Display Manufacturing Conference IDMC Illinois Dull Men's Club ) charged with overseeing this study has on four occasions reviewed the mortality and all serious adverse event data and has four times recommended that the study continue without modification. The IDMC has issued the following statement to Northfield: "As has been reported to Northfield Laboratories regarding the final assessment of the interim data, including 500 randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. patients, there were no statistically significant trends or safety issues identified to warrant modification or other changes in the current protocol and patient recruitment. The IDMC conclusion is that completion of the trial is appropriate with completion of datasets and final analysis indicated." About Northfield Laboratories Northfield Laboratories Inc. is a leader in developing an oxygen-carrying resuscitative re·sus·ci·tate v. re·sus·ci·tat·ed, re·sus·ci·tat·ing, re·sus·ci·tates v.tr. To restore consciousness, vigor, or life to. See Synonyms at revive. v.intr. To regain consciousness. fluid, PolyHeme(R), for the treatment of urgent, large volume blood loss in trauma and resultant surgical settings. PolyHeme(R) is a solution of chemically modified human hemoglobin that requires no cross matching cross matching or crossmatching n. 1. A test for determining the compatibility between the blood of a donor and that of a recipient before transfusion; the clumping of red blood cells indicates incompatibility. 2. and is therefore compatible with all blood types. It has a shelf life in excess of 12 months. Enrollment is currently underway in a pivotal Phase III trial of PolyHeme(R) beginning in the pre-hospital setting. For further information, visit www.northfieldlabs.com. This press release may contain forward-looking statements concerning, among other things, Northfield's future business plans and strategies and clinical and regulatory developments affecting our PolyHeme(R) red blood cell red blood cell: see blood. substitute product. These forward-looking statements are identified by the use of such terms as "intends," "expects," "plans," "estimates," "anticipates," "should," "believes" and similar terms. These forward-looking statements involve inherent risks and uncertainties. Our actual results may therefore differ materially from those predicted by the forward-looking statements because of various factors and possible events, including our ability to obtain FDA approval to market PolyHeme commercially, the availability of capital to finance our clinical trials and ongoing business operations, our ability to obtain adequate supplies of raw materials and to manufacture PolyHeme in commercial quantities, our ability to market PolyHeme successfully, the possibility that competitors will develop products that will render PolyHeme obsolete or non-competitive, our ability to protect our intellectual property rights, the possibility that we may be subject to product liability claims and other legal actions, our dependency on a limited number of key personnel, the uncertainty of third party reimbursement for our product and other risks and uncertainties described from time to time in our periodic reports filed with the Securities and Exchange Commission, including our most recently filed quarterly report on Form 10-Q Form 10-Q See 10-Q. and annual report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. . These forward-looking statements speak only as of the date of this press release. We do not undertake any obligation to update or publicly release any revisions to forward-looking statements to reflect events, circumstances or changes in expectations after the time such statement is made. All subsequent written and oral forward-looking statements attributable to Northfield or any person acting on our behalf are qualified by this cautionary statement. |
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