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news.Phytopharm has started the recruitment of patients with early stage Parkinson's disease into the Cogane Phase II proof-of-concept and dose ranging study.
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The Phase II study is expected to investigate the efficacy, safety and tolerability of Cogane administered for 28 weeks to approximately 400 patients with early stage Parkinson’s disease.
In the study, three doses of Cogane, administered orally once daily, will be compared with placebo.
Phytopharm said that the primary endpoint for the study will be the change from baseline to end of treatment in activities of daily living and motor function as measured by the Unified Parkinson’s Disease Rating Scale (UPDRS) Parts II and III, while the secondary endpoints will include measures of non-motor symptoms, including cognitive function and also assessments of Quality of Life.
Phytopharm Research & Development director Roger Hickling said that it was an important milestone for Phytopharm.
"Efforts will continue to ensure timely recruitment of patients into the study with the aim of delivering definitive results by the end of 2012," Hickling said.
Phytopharm scientific advisory panel member on Parkinson’s disease (PD) and one of the co-chief investigators for the study Warren Olanow said that they are hopeful, and eager to learn about the potential benefits that Coganea might have on the motor and non-motor symptoms of PD, and its effects on quality of life for patients with early-stage PD.
"Cogane is believed to be the first, orally active, small molecule inducer of neurotrophic factors to be tested in PD," Olanow said.
"It has the potential to enhance function of damaged nerve cells and protect other nerve cells from the neurodegenerative process."