Zileuton
Critical Therapeutics Announces Results from Phase II Study of Zileuton inAcne PatientsLEXINGTON, Mass.--
(Critical Therapeutics,Inc. (Nasdaq: CRTX ) today announced that the Company's Phase II study of ZYFLO®Filmtab® (zileuton tablets) in patients with moderate to severe inflammatoryfacial acne did not show statistical significance in its primary efficacyendpoint. The patients receiving zileuton did show positive responses totreatment and a trend toward significance in certain endpoints, however, theresponses did not achieve statistical significance (p less than or equal to0.050), as compared to the responses seen by patients receiving placebo. In thestudy, zileuton was found to be safe and well tolerated.The Phase II randomized, double-blind, placebo-controlled study involved101 patients with moderate to severe inflammatory facial acne who received afour-times-daily dosage of zileuton 600 mg (n=52) or placebo (n=49) for 12weeks. Patients were enrolled into the study at 12 sites across the UnitedStates and ranged in age from 12 to 44 years with the patient mean age being19.2 years. The study included a number of efficacy endpoints as measured by thechange from baseline to Week 12, such as the number of inflammatory lesions,which was the study's primary efficacy endpoint, the number of non-inflammatorylesions and the number of total lesions (inflammatory and non-inflammatory).The patients treated with zileuton showed a mean reduction in inflammatorylesions of 11.5, compared with a mean reduction of 9.1 lesions in the placebogroup (p=0.384). This corresponds to a mean percent decrease in inflammatorylesions of 33.5 percent in patients treated with zileuton, compared to 26.9percent in the placebo group. Patients treated with zileuton showed a meanreduction in the total number of lesions of 25.3, compared to a mean reductionof 16.4 lesions in the placebo group (p=0.085). Zileuton was well tolerated inthe study with no serious adverse events reported in patients. Moreover, therewere no zileuton-treated patients discontinued from the study due to elevationsof liver enzymes.The study also showed a positive trend toward significance in a subset ofpatients with more severe acne (baseline inflammatory lesions greater than orequal 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 meanreduction 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 41.6percent in patients treated with zileuton, compared to 26.2 percent in theplacebo group (p=0.025). The study also provided data regarding the rapid effectof zileuton. Patients treated with zileuton showed marginal significance in themean 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 usefultherapy in patients with moderate to severe inflammatory acne," said CriticalTherapeutics President and Chief Executive Officer, Paul Rubin, M.D. "Therelative severity of disease and size of the patient population in this studyhave given us valuable information to consider for the design of any clinicaltrials 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 theinvestigators to further interpret the results seen in this study. Once thisanalysis is complete, the Company will determine the appropriate next steps forthe development of zileuton in the treatment of patients with acne. The Companyexpects to provide further details about the study on its second quarterfinancial results conference call on Thursday, August 4, 2005.
(Critical Therapeutics,Inc. (Nasdaq: CRTX ) today announced that the Company's Phase II study of ZYFLO®Filmtab® (zileuton tablets) in patients with moderate to severe inflammatoryfacial acne did not show statistical significance in its primary efficacyendpoint. The patients receiving zileuton did show positive responses totreatment and a trend toward significance in certain endpoints, however, theresponses did not achieve statistical significance (p less than or equal to0.050), as compared to the responses seen by patients receiving placebo. In thestudy, zileuton was found to be safe and well tolerated.The Phase II randomized, double-blind, placebo-controlled study involved101 patients with moderate to severe inflammatory facial acne who received afour-times-daily dosage of zileuton 600 mg (n=52) or placebo (n=49) for 12weeks. Patients were enrolled into the study at 12 sites across the UnitedStates and ranged in age from 12 to 44 years with the patient mean age being19.2 years. The study included a number of efficacy endpoints as measured by thechange from baseline to Week 12, such as the number of inflammatory lesions,which was the study's primary efficacy endpoint, the number of non-inflammatorylesions and the number of total lesions (inflammatory and non-inflammatory).The patients treated with zileuton showed a mean reduction in inflammatorylesions of 11.5, compared with a mean reduction of 9.1 lesions in the placebogroup (p=0.384). This corresponds to a mean percent decrease in inflammatorylesions of 33.5 percent in patients treated with zileuton, compared to 26.9percent in the placebo group. Patients treated with zileuton showed a meanreduction in the total number of lesions of 25.3, compared to a mean reductionof 16.4 lesions in the placebo group (p=0.085). Zileuton was well tolerated inthe study with no serious adverse events reported in patients. Moreover, therewere no zileuton-treated patients discontinued from the study due to elevationsof liver enzymes.The study also showed a positive trend toward significance in a subset ofpatients with more severe acne (baseline inflammatory lesions greater than orequal 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 meanreduction 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 41.6percent in patients treated with zileuton, compared to 26.2 percent in theplacebo group (p=0.025). The study also provided data regarding the rapid effectof zileuton. Patients treated with zileuton showed marginal significance in themean 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 usefultherapy in patients with moderate to severe inflammatory acne," said CriticalTherapeutics President and Chief Executive Officer, Paul Rubin, M.D. "Therelative severity of disease and size of the patient population in this studyhave given us valuable information to consider for the design of any clinicaltrials 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 theinvestigators to further interpret the results seen in this study. Once thisanalysis is complete, the Company will determine the appropriate next steps forthe development of zileuton in the treatment of patients with acne. The Companyexpects to provide further details about the study on its second quarterfinancial results conference call on Thursday, August 4, 2005.
posted by Thomas Domingo | 8:48 AM
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