Universal PLAS+(R)SD Could Eliminate Plasma Shortages
WATERTOWN, Mass., April 4 /PRNewswire/ -- V.I. Technologies, Inc.
(Nasdaq: VITX) today announced that the Company has initiated a Phase III
pivotal trial for its next generation PLAS+(R)SD plasma transfusion product.
The new product, designated Universal PLAS+(R)SD, not only inactivates
lipid-enveloped viruses including HIV, hepatitis C and hepatitis B, but also
is depleted of the antibodies that cause plasma to be blood type specific.
Universal PLAS+(R)SD is designed to be safely transfused to any patient,
irrespective of blood type.
The naturally occurring universal plasma is Type AB, with Type AB donors
representing just 6% of the eligible blood donor population. Today's relative
scarcity of Type AB blood leads to shortages that can be potentially life
threatening in trauma or emergency room situations when there is little time
to determine the blood type of a badly injured patient. The availability of
the universal version of PLAS+(R)SD will therefore decrease the critical time
before treatment. In addition, the product should simplify inventory
management in blood banks and improve blood safety by reducing the possibility
of transfusion of mismatched plasma.
The Company expects to complete the pivotal trial program for Universal
PLAS+(R)SD in the second half of 2000 and file a BLA by the end of the year.
Assuming regulatory review of approximately 12 months, approval could occur in
the second half of 2001.
John Barr, President and CEO of VITEX commented, "Our research pipeline
continues to be full of products that offer major advances in blood safety.
Universal PLAS+(R)SD, now in pivotal studies, joins our virally inactivated
red cell product, which is moving through Phase I clinical trials. Universal
PLAS+(R)SD is the first application of VITEX's exciting technology platform
that joins combinatorial chemistry with affinity chromatography to remove
undesirable material from blood products in a highly specific and efficient
manner. Our next target for this particular technology platform will be the
removal of resistant pathogens such as prions."
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.
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Related links: http://www.vitechnologies.com
CONTACT: John Barr, President and CEO of V.I. Technologies, Inc., 516-752-7314, ext. 6110, or Alison Ziegler, Brian Gill, or Deanne Eagle, all of The Financial Relations Board, 212-661-8030
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