Pathogen Inactivation Treatment Proves Effective Against Bacteria as Well As
Viruses Adding an Increased Margin of Safety
WATERTOWN, Mass., July 10 /PRNewswire/ -- V. I. Technologies, Inc. (VITEX)
(Nasdaq: VITX) today announced that it will present new data on the progress
of its red cell program at the International Society of Blood Transfusion
(ISBT), which begins today in Vienna, Austria. The Company's INACTINE(TM)
pathogen inactivation treatment, which has been shown to provide a broad
spectrum of virus inactivation in blood, will also demonstrate its ability to
inactivate common forms of bacteria known to infect blood.
"The added benefit of bacterial inactivation to INACTINE(TM)'s broad
spectrum of viral kill, which we have shown in our lab experiments,
considerably enhances the value of our technology," stated John Chapman, Vice
President, Blood Products Research at VITEX. "VITEX is in the risk reduction
business, not the risk substitution business and our goal of creating a red
cell unit that has all the inherent benefits of blood with unsurpassed
pathogen safety is now within our reach."
The results to be presented will demonstrate the effectiveness of
INACTINE(TM) against Yersinia entercolitica, one of the most common bacteria
known to affect blood. Yersinia accounts for approximately 50% of bacterial
contamination of red cell units. Bacteria are found in approximately 1 in
34,000 units of blood and can result in transfusion complications such as
septic shock. Septic shock, which can lead to longer hospital stays and can
contribute to other complications including death, is reported to occur in one
in every million transfusions, with many more cases believed to go unreported.
In the experimental studies, units of blood were spiked with high
concentrations of Yersinia. After 28 days of red cell storage, units of blood
processed with the INACTINE(TM) treatment exhibited no growth of bacteria
compared to massive growth of bacteria in the control units after 7 to 14
days.
In addition, VITEX will report positive results from its toxicology
studies at the ISBT meeting. In the latest studies, INACTINE(TM) was
administered at levels more than 10,000 times those used in the normal
treatment process with no evidence of toxicity. Repeat transfusions of
INACTINE(TM) treated blood in animal models also showed no toxic effects and
no immunologic or allergic response was observed.
"We believe the toxicology and efficacy profile of INACTINE(TM) is
unmatched," stated John Barr, President and CEO of VITEX. "This should help
us establish a margin of safety that we believe other technologies will be
unable to duplicate. While our current toxicology studies are based on animal
models and the high level dosages will not be reproduced in humans, they
strengthen our belief that we should be able to move safely into human Phase
II/III testing with full units following Phase I results. The absence of an
allergic reaction also confirms that INACTINE(TM) has little to no effect on
the red cells, which is the end point we must prove in clinical trials. If
Phase II/III trials prove successful, we believe there will be a strong
probability of final FDA approval."
Red cells are the most commonly transfused blood component with over 40
million units of red cells transfused each year in the major pharmaceutical
markets worldwide. Currently there are no treatments to inactivate pathogens
in red cells. VITEX's INACTINE(TM) pathogen inactivation treatment has been
shown to inactivate enveloped viruses such as HIV, CMV, model viruses for HCV
and HBV, as well as non-enveloped viruses such as Porcine Parvo and SV40. The
new results on bacteria inactivation and the demonstration of large safety
margins establishes INACTINE(TM) as the most comprehensive pathogen
inactivation treatment which, upon approval, will significantly improve the
safety of the blood supply.
VITEX is a leading developer and manufacturer of a broad portfolio of
blood products that utilize its patented viral inactivation technologies
designed to ensure product safety. The technologies are tailored for all
blood component applications and other blood-derived products, including
plasma, plasma derivatives, red blood cells and platelets. The first of
VITEX's virally inactivated products, PLAS+(R)SD, is the only FDA-approved
method for viral inactivation of plasma.
For further information, please visit the VITEX web site at
http://www.vitechnologies.com .
Except for the historical information contained herein, the matters
discussed are forward-looking statements made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995. These
statements involve risks and uncertainties, such as quarterly fluctuations in
operating results, the timely availability of new products, market acceptance
of the company's products, the impacts of competitive products and pricing,
government regulation of the company's products and other risks and
uncertainties set forth in the company's filings with the Securities and
Exchange Commission. These risks and uncertainties could cause actual results
to differ materially from any forward-looking statements made herein.
To receive additional information on V. I. Technologies, Inc., via fax, at
no charge, dial 1-800-PRO-INFO and enter code VITX.
SOURCE V.I. Technologies, Inc. (VITEX)
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Related links:
http://vitechnologies.com
CONTACT:
John Barr, President and CEO of V.I.
Technologies, Inc., 617-726-1551, ext. 7256; or Alison Ziegler,
Cecelia Heer, Deanne Eagle of The Financial Relations Board,
212-661-8030
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