AtheroGenics Initiates Phase I Clinical Trial For Novel Oral Rheumatoid Arthritis Agent
ATLANTA, March 27 /PRNewswire/ -- AtheroGenics, Inc. (Nasdaq: AGIX), an
emerging pharmaceutical company focused on the treatment of chronic
inflammatory diseases, today announced it commenced enrollment in a Phase I
clinical trial in the United States to assess the safety and tolerability of
AGIX-4207 in healthy volunteers. AGIX-4207 is being developed for the
treatment of signs and symptoms of rheumatoid arthritis (RA).
Pre-clinical data show that AGIX-4207 blocks the generation of certain
proteins, including VCAM-1 and MCP-1, that are important in the initiation and
progression of chronic inflammatory events associated with RA. The generation
of these proteins can be stimulated by many factors, including a naturally
occurring immune system protein called Tumor Necrosis Factor alpha (TNFa).
New drugs targeting the action of TNFa have shown positive results in the
treatment of RA but must be injected and may be associated with serious side-
effects. AGIX-4207 is a selective modulator of TNFa-induced inflammatory
genes and is being tested as an oral medication, taken once a day.
In a pre-clinical study AGIX-4207 worked as well as methotrexate, the
widely used Disease Modifying Anti-Rheumatic Drug (DMARD), in the reduction of
swelling, a key measure of effectiveness. Pre-clinical studies have also
shown that AGIX-4207, in doses similar to those planned for human clinical
trials, did not compromise certain proteins essential to the body's defense
against bacterial and viral infections.
"The initiation of this Phase I clinical trial for AGIX-4207 in rheumatoid
arthritis represents another important milestone for AtheroGenics," said
Russell M. Medford, M.D., Ph.D., AtheroGenics' president and chief executive
officer. "It reflects the culmination of successful pre-clinical studies,
demonstrating that the company's proprietary v-protectant technology platform
has broad application in diseases of chronic inflammation. Because of the
unique properties of this oral compound, we are encouraged by the prospect of
bringing forward a compelling alternative therapy for the millions suffering
from this painful and crippling disease."
Rheumatoid arthritis is a chronic and progressively debilitating
inflammatory disease that affects more than two million patients in the United
States, with an estimated annual economic impact of more than $65 billion in
direct and indirect costs. Approximately 70 percent of people diagnosed with
rheumatoid arthritis are young and middle-aged women. Physicians currently
treat chronic RA in a stepwise fashion, escalating from a regimen of common
anti-inflammatory agents like aspirin or ibuprofen, to the use of increasingly
toxic drugs that affect the body's immune system, such as DMARDs. The recent
successful introduction of new drugs for rheumatoid arthritis has highlighted
both the market potential and the size and scope of the unmet medical need of
these arthritis patients.
AtheroGenics, Inc., based in Atlanta, Ga., is focused on the discovery,
development and commercialization of novel drugs for the treatment of chronic
inflammatory diseases such as heart disease (atherosclerosis), rheumatoid
arthritis and asthma. The company designed its lead product candidate, AGI-
1067, to benefit patients with coronary artery disease, which is
atherosclerosis of the blood vessels of the heart. AtheroGenics has completed
dosing of AGI-1067 in a 300-patient Phase II clinical study for the treatment
of post-angioplasty restenosis, with study results anticipated in the second
quarter of 2001. For more information, please visit atherogenics.com .
This press release may contain forward-looking statements made pursuant to
the safe harbor provisions of the Private Securities Litigation Reform Act of
1995. Such statements are subject to certain factors, risks and uncertainties
that may cause actual results, events and performance to differ materially
from those referred to in such statements. These risks include statements
which address operating performance, events or developments that we expect or
anticipate will occur in the future, such as projections about our future
results of operations or our financial condition, our collaborative efforts
with Schering-Plough Corporation, the development of our product candidates,
anticipated trends in our business, and other such risks that could cause
actual results to differ materially. These risks are discussed in
AtheroGenics' SEC filings, including the company's registration statement on
Form S-1, Registration No. 333-31140, filed with the Securities and Exchange
Commission, and including but not limited to the risks discussed in
AtheroGenics' Form 10-K report for fiscal 2000, which are incorporated by
reference into this press release. These documents may also be examined at
public reference facilities maintained by the Securities and Exchange
Commission or, to the extent filed via EDGAR, accessed through the web site of
the Securities and Exchange Commission (http://www.sec.gov).
SOURCE AtheroGenics, Inc. |
