Well I'm back in this morning at 10 1/4. I don't much care for the xenotransplant stuff, but the complement inhibitors look very encouraging:
Headline: Alexion Reports Positive Results from Phase I Clinical Trial of C5
Inhibitor For Systemic Lupus
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NEW HAVEN, Conn., June 15 /PRNewswire/ -- Alexion Pharmaceuticals, Inc.
(NASDAQ:ALXN) today announced that it has completed preliminary analysis of a
Phase I study of its anti-inflammatory complement inhibitor drug candidate
5G1.1 in systemic lupus patients. The trial was designed to gather data
regarding the pharmacodynamics, safety profile, and biological effects of a
single administration of 5G1.1 in this patient population. Preliminary
analysis showed that the drug was well-tolerated, showed a potent biologic
effect, and was associated with a significant reduction in the incidence of
proteinuria (protein in the urine), an objective measurement of kidney
dysfunction. Kidney dysfunction is a common side-effect of Lupus.
"The results of this study are encouraging since they show that in
addition to being well-tolerated, our complement inhibitor can produce a
sustained reduction in complement activity in a disease where complement
activity correlates with disease progression," said Dr. Leonard Bell,
President and Chief Executive Officer of Alexion. "Further, the fact that the
drug significantly reduced the incidence of proteinuria, supports a clinical
proof-of-principle for the role of C5 Inhibitors in the treatment of kidney
disease."
The Phase I double-blinded, placebo-controlled, ascending dose trial
examined the safety and biologic activity of 5G1.1 in 24 patients with mild
systemic lupus, each of whom received a single dose of the drug, ranging from
0.1 to 8.0 mg/kg. Of primary importance, 5G1.1 was safe and well-tolerated,
and had no detectable immunogenicity in the study population. Further, a
single dose of 5G1.1 potently blocked complement activity in patients for up
to two weeks. This sustained and potent complement inhibition was also
associated with a positive clinical effect since administration of a single 8
mg/kg dose was associated with a significant (P<.05) reduction in the
incidence of proteinuria which is an objective measurement of kidney
dysfunction. As compared to placebo-treated patients, 80% (n=6) of which had
mild transient proteinuria during the 56 day treatment period, no patients
treated with 8 mg/kg 5G1.1 (n=3) had proteinuria during the treatment period.
"There is currently a great clinical need for a nontoxic therapeutic
treatment for patients with lupus and/or kidney disease. Left untreated, a
significant proportion of patients with kidney disease will advance to kidney
failure and require dialysis," commented Dr. Christopher Mojcik, Senior
Director of Clinical Development at Alexion. "Based upon the results of the
current Phase I trial, we are moving rapidly to commence Phase II efficacy
trials in expanded kidney disease patient populations."
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. According to the Lupus Foundation, more people have this
crippling disease than AIDS, cerebral palsy, multiple sclerosis, sickle-cell
anemia and cystic fibrosis combined. Further, according to the National
Kidney Foundation, proteinuria is both a cause and indicator of progressive
loss of kidney function, more than 260,000 Americans suffer from chronic
kidney failure, and more than 50,000 people die each year because of kidney
disease.
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
rheumatoid arthritis, kidney disease and systemic lupus erythematosus.
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 and adverse changes 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 1O-K for the year ended July 31, 1998. 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.
-0- 06/15/99
/CONTACT: Leonard Bell, M.D., President and CEO of Alexion
Pharmaceuticals, 203-776-1790; or Media: Lisa Burns or Justin Jackson of Burns
McClellan, 212-213-0006; or Investors: Rhonda Chiger of Thomson Investor
Relations, 212-510-9280, all for Alexion/ |
