AtheroGenics Reports Results from Phase II Safety and Biomarker Trial of AGIX-4207 in Rheumatoid Arthritis
Larger Dose-Ranging Phase II Trial to Begin 4Q03
ATLANTA, July 16 /CNW/ -- AtheroGenics, Inc.
(Nasdaq: AGIX), a pharmaceutical company focused on the treatment of chronic
inflammatory diseases, today announced the clinical results from a 27-patient
Phase II study for AGIX-4207, the Company's oral treatment for rheumatoid
arthritis (RA). The Company also announced the next clinical trial in the
development program for the drug.
The Phase II safety and biomarker study was designed to test the safety
and tolerability of AGIX-4207 in patients currently being treated with
infusions of infliximab (Remicade(R)) and to evaluate the drug's ability to
suppress the expected increases in biomarkers for inflammation. Data from this
trial demonstrated that treatment with AGIX-4207 was safe and well tolerated
by all patients. In addition, no serious adverse events, discontinuations from
therapy or new laboratory abnormalities were noted in patients who received
the drug. There was also no evidence of any impact of AGIX-4207 on the QTc
interval, an important safety outcome.
To determine whether AGIX-4207 had an anti-inflammatory effect in this
patient population, the erythrocyte sedimentation rate (ESR), as well as
several other inflammatory markers were measured at the beginning and the end
of a three-week period. During this time frame, AGIX-4207 inhibited by 92
percent (p<0.03) the increase in ESR observed in patients on placebo. The
effect of AGIX-4207 on the other biomarkers tested was not statistically
significant although some showed trends toward benefit.
"This study provided important safety data in patients with severe RA and
the results are consistent with an anti-inflammatory effect in this patient
population," commented Rob Scott, M.D., Senior Vice President of Clinical
Development and Regulatory Affairs and Chief Medical Officer for AtheroGenics.
"We look forward to initiating our dose-ranging Phase II study which will
involve longer dosing in a larger patient sample. We believe this study,
comparing various doses of AGIX-4207 to placebo in patients who are not
receiving background therapy, will enable us to determine the clinical benefit
of the compound as well as provide the widest options for future Phase III
studies and subsequent indications."
Planning is underway for a 220-patient, 12-week, multi-center, Phase II
clinical trial of AGIX-4207, called OSCAR (Oral Suppression of Cellular
Inflammation Attenuates Rheumatoid Arthritis), which is scheduled to begin
later this year in Europe. OSCAR will evaluate the impact of various doses of
AGIX-4207 versus placebo on efficacy, biomarkers, and safety in patients with
mild to moderate RA who are not receiving background DMARDs (disease-modifying
anti-rheumatic drugs). Patients on NSAIDs (nonsteroidal anti-inflammatory
drugs) and low-dose corticosteroids will be eligible to participate in the
study.
Phase II Safety and Biomarker Study Design
The study design was a randomized, double-blind, three-arm trial,
consisting of 8 to 10 patients per arm. Three weeks prior to their next
scheduled infusions, patients on maintenance Remicade(R) infusion therapy were
randomized to either placebo or one of two, two-week dosing regimens of
AGIX-4207 150 mg once daily. Patients receiving a stable dose of Remicade(R)
every six to eight weeks, with no changes in their anti-rheumatic drug regimen
in the 12 weeks prior to enrollment in the study were eligible to participate.
About Rheumatoid Arthritis and AGIX-4207
Rheumatoid arthritis is a common auto-immune disease which affects joints
and arterial blood vessels. According to the Arthritis Foundation, there are
2.1 million people with rheumatoid arthritis in the United States. Roughly
70% of patients with rheumatoid arthritis are young and middle-aged women.
Physicians currently treat RA in a stepwise escalation, starting with
anti-inflammatory agents such as aspirin or ibuprofen, and proceeding in
resistant patients to treatment with drugs that affect the body's immune
system, termed DMARDs. New DMARDs target the modulation of tumor necrosis
factor-alpha (TNF-alpha), a protein that stimulates inflammation and other
cellular processes. The recent successful introduction of new drugs for
rheumatoid arthritis, including Celebrex(R), Enbrel(R) and Vioxx(R), has
highlighted both the market potential and the size and scope of the unmet
medical need of these patients. Importantly, these drugs are partially
effective and either increase the risk of infection or do not adequately
address the chronic inflammation that marks rheumatoid arthritis.
AGIX-4207 is a proprietary small molecule drug from AtheroGenics'
v-protectant(TM) technology platform, and represents a novel approach to
treating rheumatoid arthritis. Unlike currently marketed TNF-alpha
inhibitors, AGIX-4207 is a selective modulator of TNF-alpha induced
redox-sensitive inflammatory genes. By targeting a specific subset of
TNF-alpha induced activity, it is believed that AGIX-4207 may decrease chronic
inflammation in RA in a manner that avoids broad based immune suppression.
About AtheroGenics
AtheroGenics is focused on the discovery, development and
commercialization of novel drugs for the treatment of chronic inflammatory
diseases, including heart disease (atherosclerosis), rheumatoid arthritis and
asthma. The company has four drug development programs in the clinic.
AtheroGenics' lead compound AGI-1067 is being evaluated in a pivotal Phase III
clinical trial called ARISE (Aggressive Reduction of Inflammation Stops
Events) as an oral therapy for the treatment of atherosclerosis. AGIX-4207,
the company's second clinical compound derived from its proprietary
v-protectant(TM) technology platform, is a novel, oral agent being tested in a
Phase II clinical program for the treatment of rheumatoid arthritis.
AGIX-4207 I.V. is an intravenous rheumatoid arthritis treatment that has
completed a Phase I clinical study. AGI-1096 is a novel, oral agent that has
completed a Phase I clinical trial for the prevention of organ transplant
rejection. For more information about AtheroGenics, please visit
www.atherogenics.com. |
