Research
By ANDREW
POLLACK
Published: September 28, 2004, Tuesday
Two
experimental drugs developed by biotechnology companies --
one to prevent heart attacks and the other to help people
quit smoking -- have shown promising preliminary results,
executives said.
OOne
company, AtheroGenics, said yesterday that its drug for
atherosclerosis had significantly reduced the volume of
plaque that can clog arteries. The results, in a midstage
clinical trial, sent the company's stock soaring in
after-hours trading.
The other
company, Nabi Biopharmaceuticals, is expected to announce
today that its vaccine against nicotine helped people quit
smoking in a small clinical trial. /span>
The
results of the AtheroGenics trial had been eagerly awaited
because removing fatty plaque from the arteries is
considered a new goal for cardiovascular drug therapy. Even
the statins, the widely used anticholesterol drugs, do
little if anything to reduce plaque.
AtheroGenics said its drug, AGI-1067, reduced plaque volume
about 3 percent to 4 percent after a year, as measured with
ultrasound. The reduction was statistically significant
compared with the patients' starting levels, but not
compared with the lesser reductions in patients who got a
placebo.
Doctors in
the trial cautioned that the preliminary results covered
only 133 of about 260 patients, but nevertheless were
promising.
''We want
to see the final data but at the same time, I'm
encouraged,'' Dr. Steven E. Nissen, a cardiologist at the
Cleveland Clinic, said on a company-sponsored conference
call with analysts. ''It's a substantial change.''
Dr. Nissen
said that while it could be misleading to compare the
results of different trials, the reduction in plaque
achieved by AGI-1067 was roughly equivalent to that recorded
in a 47-patient trial last year using a drug developed by
Esperion Therapeutics. In December, shortly after the
results of Esperion's trial were announced, Pfizer agreed to
pay $1.3 billion to acquire the company.
Speculation that AtheroGenics might also be acquired -- or at
least will sell the rights to AGI-1067 for a large sum --
helped fuel the rise in the company's stock. The stock
closed down 43 cents at $23.16 in regular trading but soared
as much as 80 percent in after-hours trading.
AGI-1067,
which fights the inflammation involved in heart disease, is
in some sense more attractive than Esperion's drug because
it is taken as a pill rather than given by intravenous
infusion. AtheroGenics, based in Alpharetta, Ga., is already
in a final-stage trial to determine if the drug actually
does prevent heart attacks. If so, it hopes to apply by the
end of next year for approval from the Food and Drug
Administration.
As for
Nabi's nicotine vaccine, 33 percent of those who got the
highest dose quit smoking for at least 30 consecutive days
compared to 9 percent who got a placebo, Dr. Henrik S.
Rasmussen, Nabi's senior vice president for clinical,
medical and regulatory affairs, said in an interview. Still,
the trial was small, with only 68 patients, and it could not
be ruled out that the difference between the vaccine and the
placebo resulted from chance.
Two
investigators in the trial, Dr. Stephen I. Rennard of the
University of Nebraska and Dr. Dorothy Hatsukami of the
University of Minnesota, called the results encouraging.
Smokers
find it hard to quit because the nicotine binds to receptors
in the brain and gives them a positive feeling, Dr.
Rasmussen said.
The
vaccine, which was given by four injections over six months
in the trial, consists of nicotine connected to a detoxified
bacterial protein, which, when injected, causes the body to
form antibodies against nicotine. (Just injecting nicotine
by itself would not elicit the antibodies.) After that, if a
person smokes, the antibodies would bind to the nicotine and
prevent it from reaching the brain.
''We're
basically taking away the positive enforcement, which is the
main reason people can't stop smoking,'' Dr. Rasmussen said.
Nabi,
based in Boca Raton, Fla., will do more studies to determine
the best dose and hopes to begin final-stage trials by the
end of next year, Dr. Rasmussen said.
Xenova, a
company based in Britain, and Cytos, based in Switzerland,
are also working on nicotine vaccines, while Pfizer and
Sanofi-Aventis are testing drugs that work by other means.
The therapies already approved to help people quit smoking
are GlaxoSmithKline's drug Zyban, and a variety of patches,
gums and other products that contain nicotine, Dr. Rennard
said.
Published: 09 - 28 - 2004 ,
Late Edition - Final , Section C , Column 3 , Page 3
Device helps weak hearts pump better -- so people can live
better
By Robyn
Suriano: Sentinel Staff Writer
Just walking across the room was hard for Ella Kindergan last
year, when a weak heart kept her from doing almost
everything. But a few months ago, she trekked around Niagara
Falls on vacation while an experimental device in her chest
pushed her heart to beat more strongly.
The device belongs to a new class of implants for congestive
heart failure, a potentially crippling condition that
affects millions of people worldwide. Many stop responding
to medication, grow increasingly weak and end up
house-bound. Doctors say a portion of those patients -- up
to about 650,000 Americans -- are candidates for the
devices...
Click for Full Article
Clinical Trials
The National Institutes of Health
provides a thorough explanation of how clinical trials are
conducted and classified. Details for research participants
are discussed at
http://clinicaltrials.gov/
