Coming to an ambulance near you

by Lee Elder 2 Replies latest watchtower medical

  • Lee Elder
    Lee Elder

    Treatment to Begin with PolyHemer at the Scene of Injury

    --Company to Host Conference Call Today--

    EVANSTON, IL-March 5, 2003- Northfield Laboratories Inc. (Nasdaq:
    NFLD) announced today that it has received clearance from the U.S.
    Food and Drug Administration (FDA) to proceed with its pivotal Phase
    III prehospital trial with PolyHemer, the Company's oxygen-carrying
    blood substitute. Successful completion of the proposed trial could
    form the basis for product approval and licensure to market PolyHeme.

    "This is a gratifying day for Northfield. The clinical trial we
    proposed is unprecedented in its scope, design, and setting," said
    Steven A. Gould, M.D., Chairman and Chief Executive Officer of
    Northfield. "This favorable response represents a seminal
    achievement in our efforts to develop PolyHeme as the first blood
    substitute to be approved for use in urgent blood loss when blood is
    not immediately available."

    The trial is designed to assess the safety and efficacy of PolyHeme
    in improving survival when used to treat severely injured and
    bleeding trauma patients beginning at the scene of injury and
    continuing during ambulance transport to the hospital. Northfield
    anticipates that approximately 20 Level I trauma centers throughout
    the United States will eventually participate in the PolyHeme trial,
    with an expected enrollment of about 700 patients.
    Because the patients eligible for the study are unlikely to be able
    to provide consent due to the extent and nature of their injuries,
    the trial will be conducted under federal regulations that allow
    clinical research in emergency settings using an exception from the
    requirement for informed consent.

    "This landmark trial would not be possible without the important data
    from our recently published experience documenting the life-
    sustaining capability of PolyHeme in the hospital setting in trauma
    patients who participated in those trials," Dr. Gould said. "We look
    forward to completing the many organizational and procedural details
    that are required under the regulations before patient enrollment can

    Clinical trials at each study site are overseen by a local
    Institutional Review Board (IRB). The IRB is an independent body
    composed of medical, scientific, and nonscientific members, whose
    responsibility is to ensure the protection of the rights, safety, and
    well-being of patients enrolled in clinical trials. The traditional
    IRB approval of a clinical trial includes a requirement that informed
    consent be obtained from patients before enrollment can occur. Under
    the current regulations, the IRB responsible for the review, approval
    and continuing monitoring of a clinical trial may give approval for
    patient enrollment in trials in emergency situations without
    requiring informed consent provided specific criteria are met. The
    patients must be in a life-threatening situation, and the
    experimental therapy being evaluated must offer patients the
    potential for direct clinical benefit in the form of increased
    survival. Before enrollment can begin, the regulations require
    public disclosure of information about the trial, including the
    potential risks and expected benefits. Consultation must also occur
    with representatives of the community where the study will be
    conducted and from which the study population will be drawn. The
    process is individualized and must be tailored to the specific
    community and patient population involved. The length of time for
    IRB review and community consultation at each site may therefore vary

    "We have begun to work on these tasks, and are benefiting from our
    interactions with investigators and sites that have previously
    participated in such trials involving an exception from informed
    consent. The time required to complete these activities has ranged
    from 8 to 10 weeks to more than 6 months, depending on the specific
    site and location," Dr. Gould said.

    Northfield is also pursuing a special protocol assessment, or SPA,
    with FDA under provisions of the Prescription Drug User Fee Act of
    1992 and the Food and Drug Administration Modernization Act of 1997.
    A special protocol assessment represents acknowledgement and
    confirmation of a mutual agreement between a sponsor and FDA that
    successful completion of the proposed trial will form the primary
    basis for an efficacy claim and product approval. When agreement is
    reached, FDA commits the agreement to writing and makes it part of
    the administrative record. Such an agreement may only be changed by
    mutual agreement of the parties, or if FDA identifies a substantial
    scientific issue relevant to safety or efficacy after the testing has

    "Coming to agreement on the design and outcome of the protocol is a
    critical accomplishment. Now that we have the requisite clearance on
    the trial, we look forward to completing the final negotiations for
    special protocol assessment with FDA to solidify our regulatory
    program for the approval of PolyHeme," Dr. Gould said. "In the
    meantime, we have been diligently preparing the necessary groundwork
    for initiation of the study-identifying sites and investigators,
    selecting a contract research organization to administer the trial,
    initiating the interaction with IRBs, and preparing materials to
    support our sites in conducting public disclosure and community
    consultation. We have much work ahead of us, but look forward to
    meeting the challenge."

  • Sam Beli
    Sam Beli

    Good news for JWs.

    Here is some more information from the company's web site:

    PolyHeme® is a solution of chemically modified hemoglobin derived from human blood. Hemoglobin is the oxygen-carrying component of the human red blood cell. Northfield purchases donated blood from The American Red Cross and Blood Centers of America for use as the starting material for PolyHeme. The company uses a proprietary process of separation, filtration and chemical modification to produce PolyHeme. Hemoglobin is first extracted from red blood cells and filtered to remove impurities. The purified hemoglobin is next chemically modified using a multi-step process to create a polymerized form of hemoglobin designed to avoid the undesirable effects historically associated with hemoglobin-based blood substitutes, including vasoconstriction, kidney dysfunction, liver dysfunction and gastrointestinal distress. The modified hemoglobin is then incorporated into a solution which can be administered as an alternative to transfused blood. One unit of PolyHeme contains 50 grams of modified hemoglobin, approximately the same amount of hemoglobin delivered by one unit of transfused blood.

  • BluesBrother

    Very interesting and potentially a life saving scheme. However, I would question that this is really a "Blood substitute" if it is made from hemoglobin taken from donated blood . This is still a matter of conscience for JWs as to whether they wish to accept it , and I know of family members within the org who most certainly would not wish to accept blood based treatment. Also :

    clinical research in emergency settings using an exception from the
    requirement for informed consent.

    I am not sure that I would want to be treated with a substance that was only on trial, without consenting to it. Although I suppose that If I were at death's door already , that could make a difference to my opinion.

Share this