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olyHemeŽ 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. |
http://www.northfieldlabs.com/polyheme.htm
----- Original Message -----
From: Harry
To:
investor_relations@northfieldlabs.com
Sent: Monday, September 13, 2004 9:02 PM
Subject: Removing bloodborne pathogens
To Whom it may concern,
I've been reading, with great
interest, about your product "PolyHeme".
The question that comes to my mind is,
by using blood as a base, what processes
are in place to insure that HCV, HIV etc
do not end up in the end product? I
understand some may be proprietary in
nature so in general if that's the case.
I know that in the past blood products
have been plagued with viruses and
science has been playing catch up. To
date the screening isn't yet 100%.
Thank you in advance for your time.
Harry Hooks
-------Reply------------
Mr. Hooks---
First,
we use screened blood. Second, as
the description below indicates, we
use a proprietary process of
separation, chenical modification,
purification and formulation to
manufacture PolyHeme. I hope this
answers your question.
Sophia
Twaddell
Sophia
H. Twaddell
Vice President, Corporate
Communications
Northfield Laboratories Inc.
847.864.3500
-------Reply------------
----- Original Message -----
From: Harry
To: investor_relations@northfieldlabs.com
Cc: Rockiesnext@aol.com
Sent: Tuesday, December 14, 2004
10:44 AM
Subject: cellular blood products
Dear Sophia,
I would like to bring this to your
attention also, it follows the question
I had previously concerning the testing
of blood for pathogens at the time of
donation.
Harry
A Comment
---------
I have just seen the ProMED-mail
post on this subject [see
ref. below] and I
wish to make the following
comment.
It is true that cellular
blood products (i.e., red
cells and platelets) still
can infect recipients if the
blood donor donates shortly
after infection, before
antibodies are present. That
is why certain countries
have introduced PCR
[testing] for hepatitis C
virus, and possibly human
immunodeficiency virus
(HIV). Even with PCR,
protection cannot be 100
percent [certain] [1].
Pathogen inactivation of
cellular blood products is
under development. Products
used for pathogen
inactivation interfere with
nucleic acids of the
pathogen and might also
interfere with nucleic acids
in the blood recipient, thus
possibly becoming mutagenic
and carcinogenic. As
residual infectivity of
cellular blood products in
developed countries is very
low, the net benefit of
pathogen-inactivated blood
products is difficult to
prove.
It is highly unlikely that
6400 blood donors in Japan
donated whole blood during
the early phase of
infection. It is more likely
that the plasma of some
infectious donations entered
a plasma pool from which
6400 plasma derivatives
(e.g., albumin, coagulation
factors, and
immunoglobulins) were
produced [or that plasma
from 6400 donors was pooled
to produce those
derivatives. -
Mod.JW].
Production processes of
plasma derivatives normally
contain highly efficacious
virus inactivation
procedures. I am not aware
of break-through infections
of hepatitis C virus or HIV
through virus-inactivated
plasma derivatives during
the last 8 years, and I
would be very interested to
learn further details.
[1] Schuttler GC, Caspari G,
Jursch CA, Willems WR,
Gerlich WH, Schaefer S
(2000) Hepatitis C virus
transmission by a blood
donation negative in nucleic
acid amplification tests for
viral RNA. Lancet 355: 41-2
PD Dr. Gregor Caspari
Institut fur
Transfusionsmedizin
Brandenburg
W & T GmbH
Hochstr. 29
14770 Brandenburg an der
Havel
Germany
<gregor.caspari@dgn.de>
|
-------Reply------------
From: ir
To: Harry
Sent: Tuesday, December 14, 2004 1:07 PM
Subject: Re: cellular blood products
Harry--
will pass this along to our clinical
people.
Northfield uses screened red blood cells
in the manufacture of PolyHeme. In
addition, Northfield's proprietary
process of purification and filtration
further inactivates pathogens that might
be present. Viral load is reduced
billions of times.
Sophia H. Twaddell
Vice President, Corporate Communications
Northfield Laboratories Inc.
847.864.3500
Harry has
not had a reply from the clinical people
The average
time from Hepatitis C
exposure
to seroconversion ( antibodies
develop) is approximately 50
days, although it can be as long
as nine months (Tremolada 1991;
MJ Alter 1992).
http://www.thebody.com/tag/hepatitis/history.html
Testing an experimental blood
substitute
FOUNTAIN HILL, Pa.(AP) Lehigh
Valley hospitals are testing an
experimental blood substitute on
severely injured patients as
part of an unusual study under
way or proposed at 20 hospitals
around the country.
St. Luke's Hospital, near
Bethlehem, announced this week
that ambulance crews will
administer the blood substitute,
PolyHeme, to critically injured
patients on their way to the
trauma center.
"Since blood is not presently
carried in ambulances, the use
of PolyHeme in these settings
has the potential to address a
critical unmet medical need,"
said Dr. James Cipolla, a trauma
center physician and principal
investigator at St. Luke's.
St. Luke's Hospital joins Lehigh
Valley Hospital's Cedar Crest
trauma center as a study
participant. Since January,
several patients taken to Cedar
Crest by medical helicopter have
received PolyHeme.
Dr. Mark Cipolle, associate
chief of trauma surgeon and
principal investigator at Lehigh
Valley, said early results have
supported continuing the study.
Citing study protocols, he could
not be more specific about how
many patients received PolyHeme
and how many died.In current
practice, ambulance attendants
give a saline solution to
blood-loss patients. The
potential advantage of the blood
substitute is that it can carry
oxygen to vital organs.
Under the study guidelines,
paramedics administer either
PolyHeme or saline solution to
patients at the scene or in the
ambulance or helicopter, with
PolyHeme treatment continuing
for 12 hours while the patient
is in the hospital.
The study compares the survival
rate of patients receiving
PolyHeme with that of patients
receiving standard saline
solution.
Allentown, Bethlehem and Easton
emergency medical services will
be among the nine ambulance
corps trained by St. Luke's to
participate. St. Luke's medical
helicopter will also take part.
Supporters say PolyHeme, made by
Northfield Laboratories of
Evanston, Ill., is safer and
could save many of the nearly
100,000 people who die of
bleeding injuries each year
nationwide.
Because severely bleeding trauma
patients often are unconscious
or in shock, they are unable to
give the consent required for
experimental treatment. As a
result, the researchers in this
case are being allowed to bypass
the consent rules under a 1996
federal exemption that applies
to emergency, potentially
lifesaving research.
The exemption requires the
research to be publicized
beforehand in communities where
the study will be conducted,
both to let people opt out if
they are ever injured and to
give the community a chance to
express any objections.
RedNova News -
Chicago Hospital Joins Fake
Blood Study
CHICAGO(AP) Loyola
University Medical Center
has joined a nationwide
study of a potentially
revolutionary artificial
blood product that's being
tested in trauma patients
without prior consent,
authorities said Wednesday.
Doctors say the product
called Polyheme could
transform trauma care if it
saves lives by quickly
replacing blood loss at the
scene or en route to the
hospital.
After months of preparation,
including efforts to give
local residents a chance to
refuse participation, Loyola
began the study Monday by
equipping its medical
helicopter with Polyheme.
Hospital spokesman Stephen
Davidow said in coming weeks
Polyheme will be used in as
many as six ambulances in
three Chicago suburbs.
Because trauma patients
often are unconscious or in
shock, they are unable to
give the consent required
for experimental treatment.
As a result, the Polyheme
researchers are being
allowed to bypass the
consent rules under a 1996
federal exemption that
applies to emergency,
potentially lifesaving
research.
Polyheme's maker, Northfield
Laboratories, is the second
Illinois company to test a
blood substitute without
obtaining prior patient
consent. The first, Baxter
Laboratories, halted
research on its own
artificial blood in 1998
after the deaths of more
than 20 patients who
received the product.
While there's evidence that
Polyheme can be safely used
in hospital patients, the
study is "bringing it closer
to the time of insult and
injury by testing it in the
field," said co-researcher
Dr. Mark Cichon, director of
Loyola's emergency medical
services. He said there
hasn't been a similar
advance since World War I
research on saline fluids
that are now standard
procedure for trauma
victims.
"If the study proves that
this is a safe product, it
will in some ways
revolutionize what we are
doing for trauma patients,"
Cichon said.
Ambulances do not carry
human blood, which has a
short shelf life. Instead,
patients get an intravenous
saline solution to restore
fluid volume and blood
pressure. But unlike blood,
the fluid does not contain
tissue-nourishing oxygen, so
patients risk organ damage.
Polyheme has that blood-like
ability and is made by
extracting oxygen-carrying
hemoglobin from human red
blood cells. It can be used
in patients with any blood
type and lasts longer than
blood.
Loyola hopes to test
Polyheme on about 20
patients, and results will
be compared with 20 patients
given saline fluids, Cichon
said.
Davidow said as of
Wednesday, no patients had
been tested because none had
met the study
qualifications.
Criteria include severe
blood loss, and participants
must be older than 18.
People excluded include
pregnant women, people with
severe brain injuries and
those who require
cardiopulmonary
resuscitation to maintain
their heartbeat.
More than 700 patients
nationwide are expected to
participate in Polyheme
research at more than 20
centers. Loyola is the 16th
center to join and the only
hospital in Illinois
involved, according to a
Northfield spokesperson.
http://www.rednova.com/news/display/?id=100292
---
On the Net:
Loyola:
http://www.luhs.org/bloodsubstitute
Polyheme:
http://www.northfieldlabs.com/polyheme.htm
Source: Associated Press/AP
Online
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