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Pearl Therapeutics Advances Its Long-Acting Bronchodilator Combination Product Candidate into Four Additional Phase 2 Studies
Date:6/16/2011

earl's chief executive officer. "Pearl has instituted an iterative and integrated clinical and product development process that allows us to conduct clinical studies rapidly while maintaining a high level of rigor. Combining our novel scientific platform with our unique operational construct, we were able to complete an eight-arm, randomized, active- and placebo-controlled Phase 2b study of PT003 in fewer than nine months. We anticipate completing the four new Phase 2 studies in about 12 months, making top-line results available by mid 2012. Following the conclusion of these studies, we will meet with the U.S. Food and Drug Administration to review plans for a registrational Phase 3 program of PT003."

With the exception of the cardiovascular safety study, the primary endpoints of the Phase 2 studies will be improvement in bronchodilation as assessed by change in FEV1* (AUC0-12) relative to baseline. The cardiovascular safety study will measure the change in mean heart rate averaged over 24 hours following chronic administration of PT003, PT005, PT001 or Foradil compared to baseline obtained during the screening period. Heart rate will be evaluated using Holter monitoring. More than 500 patients with moderate-to-severe COPD will be enrolled in these four studies.

"The insights we gained from our first Phase 2b study, and those from the forthcoming Phase 2 studies will provide a strong foundation for selecting the most effective and safe doses of GP and FF in PT003 for Phase 3 trials," added Colin Reisner, chief medical officer and executive vice president of clinical development and medical affairs at Pearl Therapeutics. "We are building additional confidence in our dose selection by comparing GP efficacy with that of a short-acting muscarinic antagonist, Atrovent, in our Phase 2 study of PT001 before progressing into Phase 3. This will strengthen our GP clinical experience beyond our already co
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SOURCE Pearl Therapeutics Inc.
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