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news.Phosphagenics has received approval to commence a Phase II clinical trial of its proprietary transdermal insulin, TPM/Insulin.
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The Phase II trial is a single-blinded, placebo controlled, three-way crossover and randomized in up to 60 patients, with the endpoint of assessing the efficacy of TPM/Insulin in patients with type 1 and type 2 diabetes.
The trial, which will be conducted by CMAX at the Royal Adelaide Hospital under the guidance and supervision of Dr Sepehr Shakib, director of the dDepartment of clinical pharmacology at Royal Adelaide Hospital and Associate Professor William Hsu of the Joslin Diabetes Center at Harvard Medical School, is expected to be completed in the first half of 2008.
Dr Esra Ogru, executive vice president of R&D at Phosphagenics, said: “We are excited to reach this milestone and advance our technology for the transdermal delivery of insulin to Phase II trials.”