EVANSTON, Ill., April 2 /PRNewswire/ -- Northfield Laboratories Inc.
(Nasdaq-NNM: NFLD) has received clearance from the Food and Drug
Administration to begin Phase III trials of its blood substitute,
PolyHeme(TM).  The pivotal trials, the first Phase III study to include direct
replacement of blood in large volumes, mark a milestone in medicine's search
for an oxygen carrying blood substitute, the company said today.
    Under the Phase III protocol cleared by the FDA, surgical patients will be
infused with six units of PolyHeme, Northfield's proprietary blood substitute.
The six-unit level (3 liters containing 300 grams of hemoglobin) represents
approximately 60% of an adult's entire blood volume.
    Northfield Laboratories is the only firm to report successful achievement
of this high dose limit in any phase of clinical testing, and the only firm to
evaluate its oxygen carrier as a direct replacement for blood in high volumes
in a Phase III study.
    The randomized, controlled study will include about 250 elective surgery
patients and once underway is expected to take 12 months to complete.
    In trials leading up to this achievement, the development stage company
has infused its blood substitute in almost 100 individuals, including
infusions at an unprecedented dose level of ten units without ill effect.
This is equivalent to the replacement of a patient's entire blood volume.
    In studies of trauma patients, PolyHeme replaced the need for donated
blood on a one-to-one basis, according to the company.  Data on these trials
were presented in March at the fourth annual "Current Issues in Blood
Substitute Research and Development" seminar in San Diego sponsored by the
University of California at San Diego and the National Institutes of Health.
    "We have been exploring the clinical utility of PolyHeme throughout
Phase II studies," said Richard DeWoskin, Chairman and Chief Executive
Officer.  "We are enthusiastic about applications we see in both planned blood
loss situations such as elective surgery and unplanned blood loss situations
such as trauma and urgent surgery.
    "We expect this study to demonstrate complete avoidance of donated blood
use in a significant number of patients undergoing high-volume-blood-loss
surgical procedures.  This seems to be the most compelling endpoint in
elective surgery," said DeWoskin.
    "This trial will allow achievement of the clinical endpoint with a
moderate number of patients in a stable study setting.  Additionally, this
indication in an elective surgical setting should address potential markets
several times larger than those in the trauma settings we are also studying,"
DeWoskin noted.
    Dr. Steven Gould, Northfield's President, said, "Trials in an elective
surgery environment permit greater control and predictability, both very
important in ensuring documentation of safety in patients and the achievement
of the design goals of the study.  Given our substantial experience in trauma
settings, we are very confident the Phase III trials should proceed to a
successful conclusion.
    "Our previous clinical studies have shown the oxygen carrying capacity of
PolyHeme to equal that of blood.  In addition, we have demonstrated PolyHeme's
capability to replace blood on a unit-for-unit basis in trauma studies.
Finally, clinical studies have shown an absence of potentially dangerous
vasoconstriction even at very high dose levels.  All of the above, coupled
with an extremely high degree of viral inactivation and removal, are the
essential benefits clinicians have been searching for in a blood substitute.
Northfield's reported success with respect to these goals is unique in this
field and is very gratifying," both Gould and DeWoskin noted.

    BACKGROUND
    Northfield Laboratories was founded in 1985 to provide a corporate entity
to commercialize the scientific developments of a research team specializing
in a hemoglobin-based blood substitute.  That research, including some of the
key officers of the company today, dates back to 1970.
    PolyHeme, Northfield's blood substitute, is a solution of polymerized
hemoglobin.  Hemoglobin, contained in the red blood cell, is the molecule that
carries and transfers oxygen throughout the body.  This oxygen-carrying
quality is essential to sustaining life.  Because the red cell includes most
of the factors that require blood typing and cross-matching, a blood
transfusion is, in reality, a tissue transplant and can create some rejection
response from the recipient.  Separated from the red cell, however, raw
hemoglobin is toxic to the kidneys and can cause vasoconstriction, a
tightening of the muscle wall surrounding a blood vessel.
    Although some research into blood substitutes has included other
materials, most studies have focused on harvesting and transfusing hemoglobin,
with varying degrees of success.  Northfield's research, and its patents,
focus on the need to polymerize hemoglobin as a means of maintaining its
oxygen carrying capability while eliminating its harmful side effects.
    PolyHeme is a solution of polymerized hemoglobin molecules, essentially
small chains of linked tetrameters.  In comparison with red cell transfusion,
it is believed PolyHeme offers the following benefits:

    Disease free:  Blood transfusion can transmit diseases, including viral
diseases such as AIDS and hepatitis and parasitic diseases including malaria
and trypanosomiasis.  The production process for PolyHeme kills these disease
organisms.  The same process cannot be applied to the blood itself, however,
as it would kill the blood cells along with the unwanted viruses and bacteria.
    Universal Compatibility: Because the cell tissue is removed from the
solution, no typing or cross-matching is required, eliminating transfusion
reactions and making PolyHeme a universal donor solution.
    Immediate Availability:  Because it does not require cross-matching or
other preparation steps, PolyHeme is immediately available for transfusion in
emergency situations.
    Extended Shelf Life:  While human blood has a useful shelf life of
28-42 days, PolyHeme has a shelf life in excess of 12 months.

    In 1994, the company completed its initial public offering, raising funds
to continue its research, and returned to the market in 1995 to obtain
additional capital to bring PolyHeme to full commercial production.
    In 1996, Northfield Labs completed the first prospective, randomized,
large volume Phase II trauma trial, directly comparing the use of a blood
substitute to blood.  After having transfused patients at dosages up to six
units of PolyHeme, Northfield received FDA clearance to conduct an additional
Phase II trauma study at dosages up to ten units.
    Later in the year, the company entered into an agreement with Hemerica,
Inc., a subsidiary of Blood Centers of America, under which Hemerica would
supply Northfield with 82,500 units per year of packed red cells, the source
material for PolyHeme, at a price of $26 per unit, over a three year period.
Deliveries under that agreement are scheduled to begin in the second quarter
of 1998, close to the time Northfield expects to complete its Phase III study.
    In addition, Northfield and Hemerica agreed to a joint effort to increase
the amount of raw material available in excess of the contracted amount.  It
requires approximately two units of red cells to create one unit of PolyHeme,
according to the company.  Outdated red cells, unfit for transfusion, can be
used as a raw material for PolyHeme, however, giving these cells a "second
life" as a transfusion medium.



    Currently, the company is completing plans for a commercial-scale
production facility with a capacity of approximately 300,000 units of
PolyHeme.
    Northfield Laboratories was founded in 1985.  The Company is headquartered
in Evanston, Illinois, and its stock is traded on the Nasdaq National Market
System under the symbol NFLD.

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