Press Release Source: Northfield Laboratories Inc.
Northfield Laboratories Announces Patient Enrollment in Phase III Urban Ambulance Trial to Begin
Monday December 22, 3:42 pm ET
EVANSTON, Ill., Dec. 22 /PRNewswire-FirstCall/ -- Northfield Laboratories Inc. (Nasdaq: NFLD - News) announced today that it has received clearance to begin patient enrollment in its pivotal Phase III urban ambulance trial with PolyHeme®, the Company's oxygen-carrying blood substitute.
"I am gratified to report that Northfield has received notification of the first full approval by an Institutional Review Board (IRB) to proceed with patient enrollment in this trial," said Steven A. Gould, M.D., Chairman and Chief Executive Officer. "This is a key accomplishment for Northfield, attributable to the diligence and perseverance of the many individuals involved in the challenge of embarking on such a complex trial. We anticipate multiple other final IRB approvals in the near future.
"We have scheduled a site initiation visit prior to the end of this month and patient enrollment will begin immediately thereafter," said Dr. Gould.
The PolyHeme® urban ambulance trial is a controlled study designed to evaluate the safety and efficacy of PolyHeme® in treating severely injured and bleeding patients when blood is not immediately available. Patients meeting the eligibility criteria will be randomly assigned to receive infusions of either PolyHeme® or the current standard treatment, a saline solution. Treatment will begin before arrival at the hospital, either at the scene of the injury or in the ambulance, and continue during a 12-hour post injury period in the hospital. The study will enroll 720 patients and will be conducted at approximately 20 Level I trauma centers across the United States.
In this trial it may not be possible to obtain informed consent from the patient or a legally authorized representative due to the urgency of the situation and the extent of the injuries. The study is therefore being conducted under a federal regulation that allows research to be conducted in certain emergent, life-threatening situations using an exception from the requirement for informed consent. Authorization to proceed with patient enrollment under this regulation signifies that the IRB has completed its oversight and evaluation of the public disclosure and community consultation process that is required, as well as its comprehensive review of the study protocol.
About Northfield Laboratories
Northfield Laboratories Inc. is the leader in developing an oxygen- carrying blood substitute, PolyHeme®, for the treatment of urgent, large volume blood loss in trauma and resultant surgical settings. PolyHeme® is a solution of chemically modified human hemoglobin. In clinical trials to date, PolyHeme® has been administered in rapid, massive infusions to restore lost blood volume and hemoglobin levels. PolyHeme® requires no cross matching. It is therefore compatible with all blood types. It has a shelf life of over 12 months.
Statements in this release that are not strictly historical are "forward- looking" statements that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks, which may cause the company's actual results in the future to differ materially from expected results. These risks include, among others: competition from other blood substitute products; the company's ability to obtain regulatory approval to market PolyHeme commercially; the availability of capital to finance the company's planned clinical trials and ongoing business operations; the company's and/or its representative's ability to successfully market and sell PolyHeme; the company's ability to manufacture PolyHeme in sufficient quantities; the company's ability to obtain an adequate supply of raw materials; the company's ability to maintain intellectual property protection for its proprietary product and to defend its existing intellectual property rights from challenges by third parties; the extent to which the hospitals and physicians using PolyHeme are able to obtain third-party reimbursement; and the other risks and uncertainties described in the company's filings with the Securities and Exchange Commission.
For further information about Northfield Laboratories, visit the Web site at
www.northfieldlabs.com
Steven A. Gould
Chairman and Chief Executive Officer
(847) 864-3500
sagould@northfieldlabs.com
Sophia H. Twaddell Sharon L. Weinstein
Vice President, Corporate Communications Noonan Russo Presence
(847) 864-3500 (212) 845-4271
stwaddell@northfieldlabs.com sharon.weinstein@nrp-euro.com
Source: Northfield Laboratories Inc.
You are currently accessing this Site as a guest. Please login or register by clicking Here
Linear Mode
