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This for informational purposes for those who may be interested.
Bob from Houston
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Subject: Alexion Files Investigational New Drug Application for...
Date: Mon, 23 Feb 1998 07:23:34 EST
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Alexion Files Investigational New Drug Application for MP4 For the Treatment
of Patients Suffering from Multiple Sclerosis
NEW HAVEN, Conn., Feb. 23 /PRNewswire/ -- Alexion Pharmaceuticals, Inc.
(Nasdaq: ALXN) today announced that it has filed an Investigational New Drug
(IND) Application with the U.S. Food & Drug Administration requesting
authorization to begin a clinical trial of its proprietary Apogen, MP4, for
the treatment of patients suffering from Multiple Sclerosis (MS). This marks
the initiation of the Company's Apogen T-Cell Technology platform into human
clinical trials.
MP4 is a recombinant molecule designed to eliminate the disease-causing T-
cells in MS patients that target the nerves in the brain, thereby limiting the
autoimmune attack responsible for the paralysis and weakness in these
patients. In preclinical rodent models of multiple sclerosis published in the
Journal of Clinical Investigation (October, 1996), MP4 administration was
shown to reverse ongoing neurologic disease. In studies in primate models of
multiple sclerosis presented at the annual meeting of the American Society of
Clinical Investigation in April 1997, MP4 administration reduced the severity
of MS-like disease in a dose-dependent manner with animals receiving the
higher dose displaying no apparent clinical manifestations of disease for a
four month period.
"We are very enthused to initiate clinical development of our first Apogen
product targeting the treatment of patients suffering from MS," said Leonard
Bell, M.D., President and Chief Executive Officer of Alexion. "Moreover,
together with our announced clinical programs targeting rheumatoid arthritis,
systemic lupus, and cardiopulmonary bypass, the initiation of studies in MS
patients will represent Alexion's fourth clinical development program and the
third clinical program targeting the treatment of severe autoimmune
disorders."
Multiple Sclerosis is the most common disease-related cause of neurological
disability in early to mid-adulthood, affecting more than 350,000 Americans.
It is twice as common in women as in men. MS causes crippling loss of muscle
control and coordination, which may lead to paralysis and, in some cases,
death. In some sufferers, MS also causes loss of sensory functions and mental
acuity. MP4 represents a form of specific immunotherapy with the potential
for significant therapeutic benefits in the treatment of MS, a disease for
which current therapies have displayed limited efficacy or significant side
effects.
Alexion Pharmaceuticals, Inc. was founded in 1992 and is engaged in the
development of selective immunotherapeutic drugs that generally are designed
to inhibit the disease-causing segments of the immune system while preserving
the disease-preventing aspects of the immune system. The Company is
developing three technology platforms: C5 Complement Inhibitors and Apogen T-
Cell Therapeutics which together target severe cardiovascular and autoimmune
disorders; and xenografts for organ transplants.
This news release contains forward-looking statements. Such statements are
subject to certain factors which may cause Alexion's plans to differ or
results to vary from those expected including unexpected preclinical or
clinical results, the need for additional research and testing, delays in
manufacturing, access to capital and funding, delays in development of
commercial relationships and a variety of risks set forth from time to time in
Alexion's filings with the Securities and Exchange Commission, including but
not limited to the risks discussed in Alexion's Annual Report on Form 10-K for
the year ended July 31, 1997. Alexion undertakes no obligation to publicly
release results of any of these forward-looking statements which may be made
to reflect events or circumstances after the date hereof or to reflect the
occurrence of unanticipated events.
SOURCE Alexion Pharmaceuticals, Inc.
CO: Alexion Pharmaceuticals, Inc.
ST: Connecticut
IN: MTC
SU:
02/23/98 07:18 EST http://www.prnewswire.com
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