New Drug: ETC-642 (Re: Question: Clearing Arteries? )

hospitalpharma.comfeature.aspOpen ↗

" Most recently Esperion released further information on a
second drug, called ETC-642, which demonstrated an ability
to transport cholesterol off the artery wall at the site of
plaque build-ups. No major side effects were observed in the
Phase I, 28-patient clinical trial, which tested patients
who had fatty plaque build-ups but had not experienced an
acute heart problem. Like ETC-216, ETC-642 also demonstrated
an ability to raise HDL in the first few hours after the
drug was administered. That effect, combined with mobilizing
cholesterol off the artery walls, could potentially stop
dangerous plaque from building up or even reduce existing
plaque[more]. "

Alex

"Alex" <[email hidden]> schreef in bericht
news:...

Quoted message said:

Thanks a lot for this info.

I'm following this up as far as I can.

Alex

"J Stutzmann" <[email hidden]> schreef in
bericht .-"]news:[email hidden].-
earthlink.net...

Quoted message said:

"Alex" <[email hidden]> wrote in message
"]news:[email hidden]...

Quoted message said:

Is there any product that can clear clogged arteries,
that has not got anything to do with surgery, springs,
etc?

Any nutritional supplement, medication, etc. that can
do that?

It's most likely some kind of quackery, but I just
want to ask - is there anything in this "angioprim"
product? anginacure.comheartcleaning.htmOpen ↗

(I'm not promoting anything, but I'm just at least
intellectually exploring all possibilities.)

Alex

Alex:

Nutritional supplement -- no. but there is a product in
clinical trials managed by Cleveland Clinic that will do
just what you ask and many are pretty excited about it.

see: forrelease.comcltu044.P1.110Open ↗
42003132644.25792.html

Study Shows Infusions of Synthetic HDL 'Good
Cholesterol' Can Remove Plaque From Coronary Arteries

Results of Cleveland Clinic-Directed Study to Appear
Nov. 5 in JAMA

CLEVELAND, Nov. 4 /PRNewswire/ -- Do 40 people in a
small village in rural Italy hold the key to reversing
plaque buildup in coronary arteries? A new study
appearing in the Nov. 5 edition of the Journal of the
American Medical Association provides strong evidence
that five weekly infusions of a synthetic form of "good
cholesterol," or HDL, can remove significant amounts of
plaque from these arteries.

"This is an extraordinary and unprecedented finding,"
said Cleveland Clinic cardiologist Steven E. Nissen,
M.D., who directed the 10-center nationwide study. "This
is the first convincing demonstration that targeting
HDL, good cholesterol, can benefit patients with heart
disease, the leading cause of death in the United
States."

The development of this investigational drug is an
unusual story. About 30 years ago, researchers
discovered 40 individuals in Limone Sul Garda in
Northern Italy who appeared perfectly healthy, despite
having very low levels of good cholesterol. Ordinarily,
such people would have a high risk of heart disease, but
these people did not. Intrigued, researchers wanted to
find out why. Their studies revealed a variant in a
protein known as Apolipoprotein A- I, which is a
component of HDL. This variant was named ApoA-I Milano
after the city of Milan, where the initial laboratory
work was done.

ApoA-I Milano is being developed into a potential
treatment for heart disease by Esperion Therapeutics
Inc., an Ann Arbor, Mich.-based biopharmaceutical
company. Esperion's investigational treatment,
designated ETC-216, is a recombinant version of ApoA-I
Milano combined with a phospholipid. After pre-clinical
studies showed rapid removal of plaques from diseased
arteries, scientists at Esperion came to Dr. Nissen to
help them design a study to determine whether infusions
of the ApoA-I Milano/phospholipid complex could reverse
coronary plaque buildup in patients with heart disease.

The Cleveland Clinic-directed study administered the ApoA-
I Milano/phospholipid complex intravenously over a five-
week period to a randomized group of patients initially
hospitalized for acute chest pain. Researchers measured
arterial plaques using intravascular ultrasound (IVUS)
before and after the six-week study. Patients who were
given the synthetic protein showed a dramatic decrease
in arterial plaques, whereas a comparison group given
saline showed no change in plaques.

Atherosclerosis, sometimes known as "hardening of the
arteries," is the process by which fatty deposits build
up on the inner lining of artery walls, creating
plaques. These plaques can grow large enough to
significantly reduce blood flow. If the plaques rupture,
they can cut off blood flow to vital organs, including
the heart, causing heart attacks.

Traditional therapies for atherosclerosis focus on
lowering levels of "bad" cholesterol, known as LDL.
Although high levels of HDL have been shown to be
beneficial, the clinical significance of targeting HDL
therapeutically was unknown. This trial sought to test
that possibility.

Dr. Nissen cautions that, "Much more testing needs to be
performed to determine whether this unique form of
HDL can be used routinely to treat patients with
atherosclerosis." He emphasized that the current
clinical trial was a small "proof of concept" study,
designed only to demonstrate the potential of this
new therapy.

"People should not view new therapies as a 'magic-
bullet' cure. For most of us, medicines will never
replace the need to make healthy lifestyle choices,"
Nissen said.

"Nonetheless, this study represents a paradigm shift,"
he continued, "offering new hope for a devastating and
common disease. We now know that it is possible to
actively remove cholesterol plaques from the coronary
arteries with drugs. I am confident that eventually this
approach will make a significant difference in the care
of patients with coronary heart disease."

Study Details

The ApoA-I Milano trial involved 57 acute coronary
syndrome patients in a randomized, prospective, double-
blind, multicenter clinical trial conducted from
November 2001 to March 2003. All patients had
experienced an acute coronary syndrome, either unstable
angina (severe chest pain) or heart attack. Each patient
had a single coronary artery examined using IVUS within
two weeks following the cardiac event.

IVUS technology gives doctors the ability to visualize
coronary plaques using high-frequency sound waves. The
procedure is performed along with cardiac
catheterization. Doctors are able to see detailed images
of the interior walls of the arteries and precisely
measure the size of the plaques inside the artery.

Patients were randomized to three treatment groups --
placebo, low dose or high dose of intravenous
recombinant ApoA-I Milano/phospholipid complex. The
study drug was administered as a weekly intravenous
infusion for a total of five weeks. Patients underwent
IVUS of the originally imaged coronary artery for a
second time within two weeks following the final
infusion. The second images then were compared with
baseline images to compare plaque levels. Researchers
found a statistically significant change in volume of
the thickened, fatty lining inside the arteries of
patients who had received either the high or the low
dose of intravenous recombinant ApoA-I
Milano/phospholipid complex.

The trial was conducted in 10 community and tertiary
care hospitals throughout the United States. Researchers
at The Cleveland Clinic reviewed all IVUS examinations
without knowing which patients had received which type
of infusion. Esperion Therapeutics funded this study.

The Cleveland Clinic Foundation, located in Cleveland,
Ohio, is a not-for- profit multispecialty academic
medical center that integrates clinical and hospital
care with research and education. The Cleveland Clinic
was founded in 1921 by four renowned physicians with a
vision of providing outstanding patient care based upon
the principles of cooperation, compassion and
innovation. U.S. News & World Report consistently names
The Cleveland Clinic as one of the nation's best
hospitals in its annual "America's Best Hospitals"
survey. In 2003, The Cleveland Clinic is ranked fifth
overall. Approximately 1,200 full-time salaried
physicians at The Cleveland Clinic and Cleveland Clinic
Florida represent more than 100 medical specialties and
subspecialties. In 2002, there were nearly 2.5 million
outpatient visits to The Cleveland Clinic and more than
52,000 hospital admissions. Patients came for treatment
from every state and from more than 90 countries. The
Cleveland Clinic website address is
clevelandclinic.orgclevelandclinic.orgOpen ↗ .

CONTACT: Alicia Sokol, +1-216-445-9661, or Eileen Caruso
Sheil,

+1-216-444-8927, both of The Cleveland Clinic Foundation

Web site: clevelandclinic.orgclevelandclinic.orgOpen ↗