VIA Pharmaceuticals Announces Positive Results of Phase 2 Studies of VIA-2291 in Patients With Serious Cardiovascul... (n from baselineas compared with placebo ...)

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VIA Pharmaceuticals Announces Positive Results of Phase 2 Studies of VIA-2291 in Patients With Serious Cardiovascular Disease

Date:11/9/2008

n from baseline as compared with placebo in hs-CRP was observed over the 12 week treatment period.

--Plaque tissue

While the results of the CEA trial did not demonstrate a reduction in macrophages in the plaque tissue in carotid arteries of patients treated with 100mg VIA-2291 compared to those treated with placebo, results of a post-hoc analysis did show a reduction in necrotic core thickness relative to plaque thickness. Furthermore, mRNA levels of IL-6, a pro-inflammatory cytokine, appeared to decrease in plaque tissue from patients treated with VIA-2291. These findings may indicate anti-inflammatory activity of VIA-2291 in plaque tissue.

--Safety

The drug was generally well-tolerated in both trials. In the ACS trial, common (>10 percent) adverse events (AEs) with no clear difference between placebo and VIA-2291 treated patients included angina, fatigue, musculoskeletal pain, and headache. Laboratory abnormalities included generally mild, reversible >/= 3x upper limit of normal liver enzymes in the low dose VIA-2291 treated group (10 percent) and placebo (2 percent), not seen in the higher dose drug-treated groups; and asymptomatic >/= 1.5x lipase elevations that were more common in VIA-2291 treated patients. In the CEA study, common AEs (>7 percent) included fever, diarrhea and cystitis that occurred somewhat more commonly in VIA-2291 treated patients. Common laboratory abnormalities included mild reversible elevations of BUN and reversible decreases >1 gm/dL of hemoglobin that were more frequent in VIA- 2291 treated patients.

"We have conducted a preliminary review of the patient safety data for the VIA-2291 ACS and CEA trials and found that the drug was well-tolerated at the doses tested and support further development of VIA-2291," said Sidney Goldstein, M.D., Division of Cardiovascular Medicine, Henry Ford Hospital, Wayne State University and chairman of the VIA-2291 Data Safety Monitoring Board (DSMB), wh
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VIA Pharmaceuticals Announces Positive Results of Phase 2 Studies of VIA-2291 in Patients With Serious Cardiovascul...(n from baselineas compared with placebo ...),Health