Welichem's Phase I Clinical Trials, recently approved by Health Canada, as reported in the Company's press release dated July 10, 2007 (and in our prior newsletter), are well under way. By August 2nd, the first of our 6 cohorts will be under treatment with our anti-psoriasis drug candidate, WBI-1001. This is of course a major landmark for Welichem.
There will be 6 separate cohorts, each consisting of 6 patients. The screening process for patients for the next 5 cohorts is in progress, and we anticipate that each of the cohorts can begin 14 days after the start of treatment of the prior cohort. All of the patients in our clinical trials have mild to moderate psoriasis, which are typical of 80% of all psoriasis sufferers. All patients within a given cohort will receive the same dosage of WBI-1001's active ingredient in a topical cream on one side of their bodies; the other side will receive a placebo. Each cohort will receive a unique dosage of WBI-1001. Each patient in a given cohort will treat the affected area either once or twice a day. There will thus be 3 distinct dosage strengths tested, with application either once or twice per day.
Welichem's Phase I Clinical Trials are being run by Innovaderm Research Inc., a Canadian company based in Montreal which specializes in discrete medical research. Innovaderm undertakes responsibility for the wellbeing of patients who participate in the study at Innovaderm’s modern clinical centre. The Clinical trials are of course governed by the guidelines of Good Clinical Practices (GCP) and by Health Canada.
Innovaderm Research Inc. has been active in medical research since 1999. In its early days Innovaderm initially specialized in Phase II and Phase III Clinical Trials in the field of the Dermatology. Innovaderm has an excellent reputation for the quality and standards of its research and the care it offers to subject patients. Innovaderm also provides such services as the evaluation and drafting of research protocols, evaluation of strategies of recruitment for patient participants, and post-trials reports. Innovaderm has a professional staff of doctors, certified Clinical Research Coordinators, and others within its staff of more than 40.
Welichem is very excited to have reached this long-anticipated milestone. We are confident that the results of our Phase I Clinical Trials will be in line with our encouraging pre-clinical and theoretical results. And we are confident that reports and procedures undertaken by Innovaderm will add great industry credibility and reliability to the data, processes, and results of our Phase I Clinical Trials of our anti-psoriasis drug candidate.
We will certainly keep you posted !
Have a great August.
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