WILMINGTON, Del.--(BW HealthWire)--March 24, 1998--Nexell
Therapeutics Inc., a subsidiary of VIMRX Pharmaceuticals Inc.
(NASDAQ:VMRX), today expressed its support of the approach endorsed
by the FDA's Biological Response Modifiers Advisory Committee for
approval of stem cell selection devices for use in peripheral blood
stem cell transplantation.
The FDA Advisory Committee's comments were made at a public
session yesterday focusing on CellPro's request for approval of a
label expansion of its Ceprate(R) SC System. Although the Advisory
Committee was not asked to vote on whether or not to recommend
approval, the committee members indicated their support for approving
stem cell selection devices that provide safe engraftment and offer
the potential benefits of tumor cell depletion.
"We view the public comments made at yesterday's Advisory
Committee meeting as a very positive signal for Nexell because our
Isolex(R)300 Stem Cell Selection System pre-market application (PMA)
takes a similar approach as the one discussed at the meeting," said
L. William McIntosh, Nexell president and CEO.
A pre-market application (PMA) of Nexell's lead product, the
Isolex(R)300 Stem Cell Selection System, is currently under review by
the FDA to support the enrichment of CD34+ cells and the reduction of
non-CD34+ (non-target) cells, including tumor cells, in autologous
transplants from patients with breast cancer, non-Hodgkin's
lymphoma, and other B-cell malignancies from peripheral blood stem
cell products. The Isolex(R)300 Stem Cell Selection System is
currently marketed in Europe and a number of other countries outside
of the U.S.
The only question the FDA Advisory Panel was asked to vote on
was: "Are the findings of additional leukapheresis procedures,
platelet transfusions, and, in certain patients, impaired platelet
engraftment 1/8from CellPro's Ceprate device 3/8 acceptable given the
potential benefits of a 2-3 log tumor depletion?" The panel agreed
that the findings are acceptable.
As further background, on July 24, 1997, a federal court in
Delaware determined that CellPro (NASDAQ:CPRO) deliberately and in
bad faith infringed patents held by Johns Hopkins and its licensees -
Becton Dickinson and Baxter Healthcare Corporation. CellPro has been
ordered to pay damages to the parties and is required to phase out of
the U.S. market three months after another stem cell selection
device is approved, such as Nexell's Isolex(R)300 Stem Cell Selection
System currently under review by the FDA. CellPro is appealing the
judge's ruling.
Nexell Therapeutics Inc.
Located in Irvine, California, Nexell Therapeutics Inc. is a
biotechnology company jointly owned by VIMRX Pharmaceuticals Inc.
(NASDAQ:VMRX) and Baxter Healthcare Corporation, the principal
domestic operating subsidiary of Baxter International Inc.
(NYSE:BAX), that is developing and marketing innovative cell
therapies for cancer and other life threatening diseases. The
company's lead product, the Isolex(R)300 Cell Selection System is
marketed in Europe and other numerous countries and is currently
under regulatory review in the United States.
The Private Securities Litigation Reform Act of 1995 provides a
"safe harbor" for certain forward-looking statements. The forward-
looking statements contained in this release are subject to certain
risks and uncertainties. Actual results could differ materially from
current expectations. Among the factors which could affect the
Company's actual results and could cause results to differ from those
contained in the forward-looking statements contained herein are the
success of the Company's clinical trials, delays in receiving FDA or
other regulatory approvals and the development of competing therapies
and/or technologies by other companies.
NOTE TO INVESTORS AND EDITORS: NEXELL's press releases are available
on the Internet through www.vimrx.com and through BusinessWire's web
site at businesswire.com. The releases also are available
at no charge through Business Wire's fax-on-demand service at
800-411-8792.
CONTACT: VIMRX Pharmaceuticals, Wilmington
Media Contact: Laura A. Mastrangelo
302-998-1734/Pager 800-916-8038
or
The Investor Relations Group
Investor Contact: Dian Griesel, Ph.D.
212-664-8489
KEYWORD: DELAWARE
INDUSTRY KEYWORD: PHARMACEUTICAL
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