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BETHESDA, Md., Aug. 7, 2013 (GLOBE NEWSWIRE) -- Sucampo Pharmaceuticals, Inc. (Nasdaq:SCMP) (Sucampo) today announced the positive top-line results of two recently completed clinical trials, a Phase 1a trial of cobiprostone and a Phase 1a trial of SPI-3608. The studies tested the tolerability and pharmacokinetic profiles versus placebo of the two compounds, both of which were demonstrated to be generally well-tolerated in the tested populations.
Cobiprostone is being investigated for the prevention and/or treatment of oral mucositis. The Phase 1a clinical trial for the investigational oral spray formulation of cobiprostone demonstrated that the drug is generally well-tolerated in healthy volunteers. A Phase 1b trial is expected to begin in the fourth quarter of 2013.
"Oral mucositis is an extremely painful and often debilitating side effect of radiation therapy and chemotherapy in cancer patients, with limited prescription treatments available," said Ryuji Ueno, M.D., Ph.D., Ph.D., Chairman, Chief Executive Officer, and Chief Scientific Officer of Sucampo. "In oral mucositis, with the breakdown of the mucosal barrier function, ulcers form as surface cells die. Our pre-clinical data indicate that cobiprostone induces mucosal barrier repair and prevents mucosal barrier damage, and the fact that it was well-tolerated in this study is extremely encouraging. Even though we have not yet evaluated efficacy in patients, we are looking forward to advancing cobiprostone into Phase 1b later this year."
The single-center, randomized, double-blind, placebo-controlled, dose-escalation study conducted in Japan was designed to assess tolerability and pharmacokinetics of a single dose of cobiprostone oral spray versus placebo in healthy adults aged 21–50 years. Approximately 48 individual subjects were analyzed, 36 of whom were treated with cobiprostone.
The study consisted of six escalating-dose steps and one repeat-dose step. In total, six doses of cobiprostone were tested. No serious or severe adverse events (AEs) were reported and the most frequently observed AE was mild diarrhea.