Only this...IMHO....made me BUY today!
Wednesday March 25, 9:11 am Eastern Time
Company Press Release
Nexell Supports FDA Advisory Committee Discussion on Stem Cell
Selection
WILMINGTON, Del.--(BW HealthWire)--March 24, 1998--Nexell Therapeutics Inc., a subsidiary of VIMRX Pharmaceuticals Inc.
(NASDAQ:VMRX - news), 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 [from CellPro's Ceprate device]
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 - news)
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 - news) and Baxter Healthcare Corporation, the principal domestic operating subsidiary of Baxter
International Inc. (NYSE:BAX - news), 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
More Quotes
and News:
Baxter International Inc (NYSE:BAX - news)
CellPro Inc (Nasdaq:CPRO - news)
VIMRX Pharmaceuticals Inc (Nasdaq:VMRX - news)
Related News Categories: biotech, medical/pharmaceutical
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