Study appearing in November 5, 2003 issue of Journal of the American Medical
Association (JAMA) provides significant evidence of rapidly reduced
atherosclerosis with investigational HDL therapy
Esperion will host conference call on Tuesday, November 4, 2003,
at 4:30 p.m. to discuss results.
ANN ARBOR, Mich., Nov. 4 /PRNewswire-FirstCall/ -- Esperion Therapeutics,
Inc. (Nasdaq: ESPR) today announced the results of a study providing
significant evidence that its investigational product candidate, ETC-216
(ApoA-I Milano/phospholipid complex or AIM), rapidly reduced the size of
plaque in coronary arteries and reversed atherosclerosis. The results of the
study appear in the November 5, 2003 issue of the Journal of the American
Medical Association (JAMA). The study is the first clinical evidence that
atherosclerosis, a progressive disease resulting from deposits of fatty
substances such as cholesterol in the artery walls, can be rapidly reversed.
"These results demonstrate for the first time that it is possible to
rapidly regress the major underlying cause of heart attack," said Roger S.
Newton, Ph.D., President and CEO of Esperion Therapeutics. "By enhancing the
removal of cholesterol from plaques in artery walls, a process known as
reverse lipid transport, HDL therapy may provide an innovative approach to the
treatment of atherosclerosis. We are excited about these results and look
forward to continuing the development of ETC-216 in more patients with longer
follow-up and assessing more endpoints, including morbidity and mortality."
In the Phase 2 clinical trial, 47 patients with acute coronary syndromes
(ACS) received five weekly intravenous infusions of placebo (n=11 patients),
ETC-216 at 15 mg/kg (n=21 patients) and ETC-216 at 45 mg/kg (n=15 patients).
Plaque volume was measured before treatment and within two weeks after the
final infusion using intravascular ultrasound (IVUS). With IVUS, a tiny
ultrasound probe is inserted into the coronary artery to directly image and
measure the size of the atherosclerotic plaques. The study revealed a
statistically significant reduction (p=0.02) in percent atheroma (plaque)
volume in the combined ETC-216 treatment groups comparing end-of-treatment
values to baseline values.
Additional IVUS endpoints in the trial, such as total atheroma volume and
maximum atheroma thickness, also showed statistically significant
improvements.
"This study shows that ETC-216 could become an important new option for
the treatment of people affected by atherosclerosis," said Steven E. Nissen,
M.D., F.A.C.C., principal investigator of the study and medical director of
the Cleveland Clinic Cardiovascular Coordinating Center. "We now have
evidence that it is possible to rapidly and directly reverse the
atherosclerotic disease process in artery walls."
Of the 57 patients assigned to a treatment group, 47 patients completed
the trial. Of the ten patients who did not complete the trial, two were
withdrawn for an adverse event, three withdrew consent and five had IVUS
studies that were not analyzable. Overall adverse event rates were similar in
all three treatment groups and ETC-216 was generally well-tolerated.
Cholesterol is transported in the bloodstream by special carriers called
lipoproteins. Low density lipoprotein (LDL), often referred to as "bad"
cholesterol, transports cholesterol to the body's cells. High levels of LDL-
cholesterol can lead to the build-up of cholesterol and other fats in the
walls of arteries. These deposits can eventually form a plaque. If a plaque
ruptures and a clot forms and blocks an artery, it can cause a heart attack.
High-density lipoprotein (HDL), often referred to as "good" cholesterol, is
believed to remove cholesterol and other lipids from artery walls and other
tissues and transport them to the liver where they are eliminated from the
body.
ApoA-I Milano is a variant of ApolipoproteinA-I (ApoA-I), the major
protein component of HDL. ApoA-I Milano is present in a small population of
northern Italians with paradoxically low levels of HDL-cholesterol. Low HDL-
cholesterol levels normally would correlate with high risk for cardiovascular
disease, but carriers of the ApoA-I Milano gene show a reduced risk,
presumably due to enhanced reverse lipid transport (RLT), the body's process
of removing excess cholesterol and other lipids from artery walls and other
tissues and transporting them to the liver for elimination. ETC-216 (AIM) is
a human recombinant version of ApoA-I Milano combined with a phospholipid to
form a complex that imitates the structure and function of HDL. ETC-216 is
designed to mimic the beneficial properties of HDL and enhance RLT.
According to the American Heart Association, more than 60 million
Americans have some form of cardiovascular disease. It is the leading cause
of death in the United States, claiming the lives of nearly one million
Americans each year.
Esperion Will Host Conference Call on Tuesday, November 4, at 4:30 p.m.
Esperion will hold a conference call at 4:30 p.m. (ET) on Tuesday,
November 4, 2003 to discuss the results of the Phase 2 clinical study of
ETC-216 (AIM). Investors and others are invited to join the call live via
telephone or on the Internet.
What: Esperion Conference Call to Discuss ETC-216 (AIM) Study
Results
When: Tuesday, November 4, at 4:30 p.m. (ET)
Via Telephone: From U.S. and Canada, dial (800) 901-5226
From other locations, dial (617) 786-4513
All callers should use the conference ID "Esperion."
Via Internet: Visit http://www.esperion.com , click on the Investor
Relations link and then the Calendar link shortly before
4:30 p.m. (ET).
A replay of the Esperion conference call will be available beginning at
8:00 p.m. (ET) on November 4, 2003, until 11:59 p.m. (ET) on November 11,
2003. To access the replay from the U.S. and Canada, dial (888) 286-8010 and
enter passcode #92056812. From all other locations, dial (617) 801-6888 and
enter passcode #92056812. To access the replay via the Internet, visit
http://www.esperion.com , click on the Investor Relations link and then click
on the Audio/Visual Archives link.
Esperion Therapeutics
Esperion Therapeutics, Inc. discovers and develops pharmaceutical products
for the treatment of cardiovascular disease. Esperion intends to
commercialize a novel class of drugs that focuses on a new treatment approach
called "HDL Therapy," which is based on the Company's understanding of high-
density lipoprotein, or HDL, function. HDL is the primary facilitator of the
RLT pathway by which excess cholesterol and other lipids are removed from
arteries and other tissues and are transported to the liver for elimination
from the body. Esperion's goal is to develop drugs that exploit the
beneficial functions of HDL within the RLT pathway. Esperion currently has
four product candidates in clinical development. Esperion is listed on the
Nasdaq National Market under the symbol "ESPR." For more information, visit
http://www.esperion.com .
Safe Harbor Statement
The information contained in this press release includes "forward-looking
statements" within the meaning of the Private Securities Litigation Reform Act
of 1995. These forward-looking statements are often identified by words such
as "hope," "may," "believe," "anticipate," "plan," "expect," "require,"
"intend," "assume" and similar expressions. Forward-looking statements speak
only as of the date of this press release, reflect management's current
expectations, estimations and projections and involve certain factors, such as
risks and uncertainties, that may cause actual results, performance or
achievements to be far different from those suggested by the Company's
forward-looking statements. These factors include, but are not limited to,
risks associated with: the Company's ability to successfully execute its
business strategies, including entering into strategic partnerships or other
transactions; the progress and cost of development of the Company's product
candidates; the extent and timing of market acceptance of new products
developed by the Company or its competitors; the Company's dependence on third
parties to conduct clinical trials for the Company's product candidates; the
extent and timing of regulatory approval, as desired or required, for the
Company's product candidates; the Company's dependence on licensing
arrangements and strategic relationships with third parties; clinical trials;
manufacturing; the Company's dependence on patents and proprietary rights;
litigation, proceedings, investigations and other disruptions of management's
time resulting from the acquisition of the Company's common stock by various
persons associated with Scott Sacane; the procurement, maintenance,
enforcement and defense of the Company's patents and proprietary rights;
competitive conditions in the industry; business cycles affecting the markets
in which any of the Company's future products may be sold; extraordinary
events and transactions; seeking and consummating business acquisitions,
including the diversion of management's attention to the assimilation of the
operations and personnel of any acquired business; the timing and extent of
the Company's financing needs and the Company's access to funding, including
through the equity market, particularly in light of the impact on the market
value of the Company's common stock of matters outside of the Company's
control, such as trading activities by third parties; fluctuations in foreign
exchange rates; and economic conditions generally or in various geographic
areas. Because all of the foregoing factors are difficult to forecast, you
should not place undue reliance on any forward-looking statement. More
detailed information about some of these and other risk factors is set forth
in the Company's filings with the Securities and Exchange Commission. The
Company does not intend to update any of these factors or to publicly announce
the results of any revisions to any of these forward-looking statements other
than as required under the federal securities laws.
Company Amy Cannon
Contact: Manager, Corporate Communications
Esperion Therapeutics, Inc.
(734) 222-1801
acannon@esperion.com
Media Jim Wetmore
Contact: Berry & Company Public Relations
(212) 253-8881
jwetmore@berrypr.com
SOURCE Esperion Therapeutics, Inc.
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Related links:
http://www.esperion.com
CONTACT:
Company Contact: Amy Cannon, Manager,
Corporate Communications of Esperion Therapeutics, Inc.,
+1-734-222-1801, acannon@esperion.com ; Media Contact: Jim
Wetmore of Berry & Company Public Relations, +1-212-253-8881,
jwetmore@berrypr.com
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