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Technology Stocks : Critical Therapeutics (CRTX) -- Ignore unavailable to you. Want to Upgrade?

To: tuck who wrote (9)	7/14/2005 9:20:20 AM
From: nigel bates	Respond to of 31

Critical Therapeutics Announces Results from Phase II Study of Zileuton in Acne Patients Thursday July 14, 9:05 am ET LEXINGTON, Mass.--(BUSINESS WIRE)--July 14, 2005--Critical Therapeutics, Inc. (Nasdaq: CRTX - News) today announced that the Company's Phase II study of ZYFLO® Filmtab® (zileuton tablets) in patients with moderate to severe inflammatory facial acne did not show statistical significance in its primary efficacy endpoint. The patients receiving zileuton did show positive responses to treatment and a trend toward significance in certain endpoints, however, the responses did not achieve statistical significance (p less than or equal to 0.050), as compared to the responses seen by patients receiving placebo. In the study, zileuton was found to be safe and well tolerated. The Phase II randomized, double-blind, placebo-controlled study involved 101 patients with moderate to severe inflammatory facial acne who received a four-times-daily dosage of zileuton 600 mg (n=52) or placebo (n=49) for 12 weeks. Patients were enrolled into the study at 12 sites across the United States and ranged in age from 12 to 44 years with the patient mean age being 19.2 years. The study included a number of efficacy endpoints as measured by the change from baseline to Week 12, such as the number of inflammatory lesions, which was the study's primary efficacy endpoint, the number of non-inflammatory lesions and the number of total lesions (inflammatory and non-inflammatory). The patients treated with zileuton showed a mean reduction in inflammatory lesions of 11.5, compared with a mean reduction of 9.1 lesions in the placebo group (p=0.384). This corresponds to a mean percent decrease in inflammatory lesions of 33.5 percent in patients treated with zileuton, compared to 26.9 percent in the placebo group. Patients treated with zileuton showed a mean reduction in the total number of lesions of 25.3, compared to a mean reduction of 16.4 lesions in the placebo group (p=0.085). Zileuton was well tolerated in the study with no serious adverse events reported in patients. Moreover, there were no zileuton-treated patients discontinued from the study due to elevations of liver enzymes. The study also showed a positive trend toward significance in a subset of patients with more severe acne (baseline inflammatory lesions greater than or equal to 30). In these more severe patients, those treated with zileuton (n=26) showed a mean reduction of 16.2 inflammatory lesions, compared with a mean reduction of 11.7 inflammatory lesions in the placebo group (n=24) (p=0.063). This corresponds to a mean percent decrease in inflammatory lesions of 41.6 percent in patients treated with zileuton, compared to 26.2 percent in the placebo group (p=0.025). The study also provided data regarding the rapid effect of zileuton. Patients treated with zileuton showed marginal significance in the mean reduction of total facial lesions at Week 4 (p=0.078) and Week 8 (p=0.057). "We believe this small trial supports that 5-LO inhibition may be a useful therapy in patients with moderate to severe inflammatory acne," said Critical Therapeutics President and Chief Executive Officer, Paul Rubin, M.D. "The relative severity of disease and size of the patient population in this study have given us valuable information to consider for the design of any clinical trials in acne patients that we may decide to pursue in the future." The Company is continuing to analyze the data and will be working with the investigators to further interpret the results seen in this study. Once this analysis is complete, the Company will determine the appropriate next steps for the development of zileuton in the treatment of patients with acne. The Company expects to provide further details about the study on its second quarter financial results conference call on Thursday, August 4, 2005. About Acne Vulgaris Acne is the most common skin disorder, affecting nearly 17 million people in the United States and resulting in 19 million prescriptions annually. Approximately 85 percent of those with the disease are between the ages of 12 and 24. While not a serious health threat, acne can produce disfiguring and permanent scarring. About ZYFLO® (zileuton tablets) ZYFLO was approved by the U.S. Food and Drug Administration (FDA) in 1996 for the treatment of asthma in patients 12 and older. ZYFLO blocks the activity of 5 lipoxygenase (5-LO), the enzyme chiefly responsible for producing a range of inflammatory mediators known as leukotrienes, which are believed to play a central role in tissue inflammation related to asthma, acne and other diseases. Critical Therapeutics has submitted a supplemental New Drug Application (sNDA) with the FDA to produce ZYFLO at contract manufacturing sites. Pending approval of the sNDA, the Company expects to begin marketing ZYFLO in the United States for asthma in the fourth quarter of 2005.