Hello merlyn-ga,
Nice to see you again, and thanks so much for the opportunity to
answer your question.
The drug you are seeking information for is AGI-1067, and the company
that produces it is AtheroGenics.
AGI-1067 is one of a new class of drugs designed to directly prevent
heart attacks and related conditions by reducing the inflammation that
underlies atherosclerosis (hardening of the arteries caused by
deposits of fats and cholesterols and other plaque-forming
substances).
I've provided links to information about the company, the drug and the
current Phase III clinical trial underway. I've also included
excerpts from the key documents, but I would encourage you to visit
the pages themselves for full information.
As always, if anything here is not clear, or if you need additional
information, just let me know, and I'll be happy to assist you
further.
pafalafa-ga
------------------
You can read general information about AtheroGenics, the company that
produces AGI-1067, at their web site:
http://www.atherogenics.com
AtheroGenics is a pharmaceutical company focused on the discovery,
development and commercialization of novel drugs for the treatment of
chronic inflammatory diseases, such as atherosclerosis, asthma, and
arthritis.
-------------------
A brief description of AGI-1067 can be found here:
http://www.atherogenics.com/science/product.html
AtheroGenics is currently conducting clinical trials for four of its
products. AGI-1067, a novel oral agent for the treatment and
prevention of atherosclerosis, is the first in a new class of drugs
known as vascular protectants, or v-protectants...
------------
A much more in-depth description of AGI-1067 is here:
http://www.atherogenics.com/science/product.html#0
AGI-1067 for Atherosclerosis
Our lead v-protectant product candidate, AGI-1067, is a novel small
molecule that was designed to treat atherosclerosis of the blood
vessels of the heart, or coronary artery disease. We believe that
AGI-1067 may treat all areas of the coronary artery susceptible to
atherosclerosis in a way that cannot be achieved with any existing
therapy...
AGI-1067 was studied pre-clinically in multiple species to establish
its therapeutic properties. Dosed orally, AGI-1067 blocked VCAM-1
expression, prevented atherosclerosis and showed potent anti-oxidant
activity. Based upon the successful completion of pre-clinical
testing, AGI-1067 was studied in seven Phase I clinical trials in more
than 150 men and women, including healthy volunteers and patients up
to the age of 85, to assess tolerability and potential for interaction
with other drugs. In addition, we have given AGI-1067 in combination
with other drugs commonly used in patients with atherosclerosis. In
these clinical trials the subjects tolerated AGI-1067 well, with no
dose or use-limiting side effects. These positive results supported
our progress to Phase II clinical trials...
[After presenting results of their Phase II trials, the discussion
then goes on to describe the current Phase III testing, known as
ARISE]
The Phase III trial, referred to as ARISE (Aggressive Reduction of
Inflammation Stops Events), is being conducted in approximately 180
cardiac centers throughout the United States, United Kingdom, Canada
and South Africa. ARISE will evaluate the impact of AGI-1067 on
important outcome measures such as death due to coronary disease,
myocardial infarction, stroke, coronary re-vascularization and
unstable angina in patients who have coronary heart disease. The study
will also assess the incremental benefits of AGI-1067 versus the
current standard of care in this patient population...
-------------------
This link contains the company's press release announcing the Phase
III trial:
http://www.atherogenics.com/press/index.html
30-Jun-03 AtheroGenics Commences Enrollment in Pivotal ARISE Phase
III Clinical Trial of AGI-1067 for Atherosclerosis
"AGI-1067 will be evaluated as the first drug to directly target the
underlying inflammation of atherosclerosis, as opposed to current
cardiovascular therapies that merely address risk factors."
-------------------
At this site, run by Prous Science, AGI-1067 was nominated as
"Molecule of the Month":
http://www.prous.com/mom/may_02/mom.html
AtheroGenics' AGI-1067 is the first in a promising new class of orally
available compounds known as composite vascular protectants, or
v-protectants. Composite v-protectants are small-molecule phenolic
antioxidants with a dual mechanism of action that involves protecting
the arterial lining and lowering LDL cholesterol levels. AGI-1067
functions as a v-protectant by blocking the production of a selective
set of inflammatory genes, including VCAM-1 and MCP-1, which have been
implicated in the initiation and progression of atherosclerosis....
AtheroGenics had been collaborating with Schering-Plough in the
development of AGI-1067; however late last year, by mutual agreement,
the former reacquired all rights to the compound and announced it
hoped that future clinical development of the v-protectant would
consequently be expedited.
-------------------
This federal government site consolidates information on drugs in
clinical trial, and has a page on the ARISE trials for AGI-1067:
http://www.clinicaltrials.gov/ct/show/NCT00066898?order=2
ARISE -- Aggressive Reduction of Inflammation Stops Events
This study is currently recruiting patients.
Sponsored by AtheroGenics
Purpose:
To assess the safety and efficacy of AGI-1067, as compared to placebo,
in the treatment of vascular inflammation and atherosclerosis by
assessing the reduction in cardiovascular events.
Conditions:
Atherosclerosis
Coronary Artery Disease
Myocardial Infarction
Unstable Angina
Contact information: Sineth Desai 714-210-5591
sdesai@integrium.com
[The site also lists all locations around the world where Phase III
trials for this drug are being conducted]
-------------------
Again, I hope this is the information you were seeking, but if you
need any additional information, just let me know.
pafalafa-ga
search strategy: Google searches on:
ArthroGanics
AtheroGenics
AGI-1067 ARISE |
Clarification of Answer by
pafalafa-ga
on
08 Oct 2003 18:03 PDT
Hello again Merlyn,
Perhaps I wasn't explicit enough in drawing your attention to the
chemical information.
The "molecule of the month" link:
http://www.prous.com/mom/may_02/mom.html
has a diagram of AGI-1067, a two-ring organic chemical, which is
described as a small phenolic molecule with antioxidant properties.
My apologies if I didn't fully address your original question...I had
thought the chemical information was adequate.
An additional description of the AGI-1067 molecule can be found in a
recent article in Scientific American, which is online at:
http://www.sciam.com/article.cfm?articleID=0001F400-70D6-1ED9-8E1C809EC588EF21
and describes the molecule as a modified form of another drug,
Probucol:
Probucol's powerful antioxidant properties made it attractive, if its
chemical structure could somehow be altered to eliminate its
liabilities--among other things, it had trouble getting into
endothelial cells and was sometimes linked to cardiac rhythm
abnormalities. The molecule was symmetric in shape. The two phenol
groups at each end of its linear molecular chain were what caused the
drug to act as an antioxidant. The medicinal chemists removed one or
both phenols, replaced them with a number of other side groups, and
tested the activity of the altered molecules. One of the molecules
tried, AGI-1067, had qualities superior to any other candidate tested.
In AGI-1067, one phenol was replaced with another organic compound (an
ester--more specifically, a succinate hydroxyl group). Leaving one
phenol allowed it to remain as potent an antioxidant as Probucol, and
the addition of the ester let it penetrate cells and obviated any
safety concerns.
------------------
I hope this is the type of information you were looking for, but if
not, just post another Request for Clarification, and let me know what
additional information you would like.
And please...once you've rated a question, there's no way to add
additional stars, or otherwise change the rating, so it's best for
everyone to hold off your rating until the process is finished. I'm
always willing to continue working on a question until a customer is
fully satisfied with the answer...you deserve nothing less than a
5-star response.
Hope we'll have an opportunity to work together again.
pafalafa-ga
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