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PDF Statement on Results of Recent Cogane Clinical Trial

The manufacturer Phytopharm has announced that a clinical study of CoganeTM, an experimental treatment being tested for use in early Parkinson's disease, has been unsuccessful. 

Cogane is an oral medication that was being studied in a Phase II trial with 400 participants, all living with early stage Parkinson’s disease.  In animal models, Cogane was able to stimulate the production in the brain of growth factors, naturally occurring substances in the body that nourish new brain cells and help to restore sick cells. Previous studies encountered many challenges when trying to increase levels of growth factors in the brain. The PD community had hoped that this simple treatment might be able to overcome such challenges.

The manufacturer has not yet released the data from this clinical trial. When it does, PDF’s Medical Policy Committee will review and provide its interpretation for the PD community. In the meantime, PDF recommends contacting our HelpLine with any additional questions about PD treatments at (800) 457-6676 or info@pdf.org.

Phytopharm Hit by Failure of Parkinson's Drug

LONDON (Reuters) - Phytopharm said its major drug hope for treating Parkinson's disease had failed in a clinical trial, the latest British biotech company to disappoint after showing early promise.

Shares in Phytopharm fell more than 80 percent on Monday after it said its drug, Cogane, showed no benefit over placebo in the treatment of more than 400 patients with early-stage Parkinson's, a neurodegenerative disease.

Chief Executive Tim Sharpington said he was disappointed.

"Cogane had demonstrated encouraging efficacy in a wide range of industry standard pre-clinical models but this promise has not translated into clinically meaningful efficacy," he said.

Phytopharm hoped its compounds had the potential to be a new class of therapy for neurodegenerative diseases, motor neuron disease and glaucoma.

Cogane had demonstrated neuroprotective effects in preclinical models, the company had said, with indications that it could ease the symptoms and slow the progression of Parkinson's, a condition where part of the brain becomes more damaged over time.

Phytopharm said on Monday it had halted all research and development spending while it reviewed its drugs pipeline.

Its shares were trading down 82.25 percent by 4.14 a.m. ET, giving it a market value of just over 6 million pounds.

Analyst Paul Cuddon at Peel Hunt said the result was a conclusive failure for Phytopharm's key asset, and he attributed no value to the group's remaining pipeline of drugs.

"The comprehensive nature of the failure raises questions over the relevance of the pre-clinical models used, and the size/expense of the trial that was required to prove that Cogane was futile," he said.

"Ultimately this outcome should have been reached at a lesser loss for shareholders."

He said Phytopharm was likely to join the ranks of Renovo, Minster and Antisoma , of all which saw promising drugs fail in later-stage clinical trials.

"Until companies are better able to select for specific genetically defined patients for targeted drugs, UK pre-revenue drug development companies will remain a lottery," Cuddon said.

(Reporting by Paul Sandle; Editing by Erica Billingham)

 

Source Date: Feb 19 2013
Source Publication: Reuters
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