NEW HAVEN, Conn., July 23 /PRNewswire/ -- Alexion Pharmaceuticals, Inc.
(Nasdaq: ALXN) today announced that it has recently commenced dosing Lupus
patients in a Phase I/II clinical trial of its anti-inflammatory C5 complement
inhibitor drug candidate 5G1.1. The double-blinded, placebo-controlled,
ascending dose study is expected to enroll 24 patients. The trial is designed
to gather clinical data regarding the safety profile and biological effects of
5G1.1 in patients suffering from systemic lupus erythematosus (Lupus).
"In rapid succession, we have now initiated a clinical trial of 5G1.1 for a
second clinical indication, the treatment of Lupus. The initiation of this
trial, together with the commencement of our Rheumatoid Arthritis trial
earlier this month, represents an important milestone as this drug is the
first complement inhibitor to enter into clinical development for the
treatment of autoimmune diseases," said Leonard Bell, M.D., President and
Chief Executive Officer of Alexion. "Over the past half century, it has been
firmly established that pathologic complement activity is a key factor in the
development of Lupus. In pursuing this additional clinical target, we hope to
utilize this advanced understanding of Lupus pathogenesis in order to provide
therapeutic benefits for patients suffering from the debilitating consequences
of this devastating autoimmune disease."
According to the Lupus Foundation of America, Lupus affects 1 out of every 185
Americans, and thousands of Americans die each year from Lupus-related
complications. The Foundation says that more people have this crippling
disease than AIDS, cerebral palsy, multiple sclerosis, sickle-cell anemia and
cystic fibrosis combined. Although Lupus may affect people of either sex,
women are 10-15 times more likely to suffer from the disease than men.
Dr. Louis Matis, Senior Vice President and Chief Scientific Officer, said,
"This is another step towards realizing the promise of our pre-clinical
findings in an animal model of Lupus, published in the Proceedings of the
National Academy of Sciences, showing that over six months Alexion's C5
Inhibitor treatment markedly increased survival from less than 5% in control
animals to nearly 80% in animals treated with C5 Complement Inhibitor therapy.
In addition, the significant reductions in levels of biological markers
associated with inflammation seen in our previous clinical trial studies of
our first C5 Inhibitor, 5G1.1-SC, give a good indication that the related
5G1.1 drug candidate will also show beneficial anti-inflammatory effects."
The anti-inflammatory effects of Alexion's first drug candidate, 5G1.1-SC,
were recently reported to significantly reduce cardiac damage, new cognitive
(brain) deficits, and blood loss in patients undergoing coronary artery bypass
graft surgery involving cardiopulmonary bypass. Alexion has earlier announced
plans to begin clinical development of 5G1.1-SC for the treatment of acute
myocardial infarction (heart attack) later this year.
Alexion's C5 inhibitors (5G1.1 and 5G1.1-SC) are specific and potent
recombinant drugs which are designed to intervene in the complement cascade.
The Company believes that these proprietary C5 Inhibitors intervene at an
optimal point which generally preserves the normal disease-preventing
functions of complement proteins while generally inhibiting the disease-
causing actions. 5G1.1 is a novel fully humanized monoclonal antibody,
specifically designed to deliver potent anti-complement and anti-inflammatory
activity to patients suffering from chronic inflammatory diseases, including
the auto-immune disorders rheumatoid arthritis and systemic lupus.
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 transplantation.
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 pre-clinical 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 HEA FIN
SU:
07/23/98 07:32 EDT http://www.prnewswire.com