Italy's Newron wins U.S. drug trial approval

[cljanney]

Anyone heard anything about this drug, Ralfinamide?

Trials are supposedly coming here toward the end of the year.



http://www.reuters.com/article/healt...19327720070629

Italy's Newron wins U.S. drug trial approval

FDA approval of Ralfinamide application

ZURICH, June 29 (Reuters) - Italy-based biotech company Newron Pharmaceuticals SpA (NWRN.S: Quote, Profile, Research) said it won approval from the U.S. Food and Drug Administration for an application to carry out clinical trials of its ralfinamide compound.

An investigational new drug application was granted by the FDA to conduct the trials of the compound for treatment of neuropathic pain and followed a review by the agency of all preclinical and clinical data generated by Newron.

Newron said in a statement it expected to start further trials by the fourth quarter of 2007. All previous trials of the drug were carried out in Europe and India.

Earlier Newron said it had reached a commercial settlement with Purdue Neuroscience Co with regard to patents relating to certain compounds, including ralfinamide.

The agreement gives Newron the option to acquire, by assignment from Purdue, ownership of a number of worldwide patents and patent applications related to use of certain compounds for treating pain, including but not only ralfinamide.

Ralfinamide is a compound being developed by Newron to treat neuropathic pain and is currently in clinical phase II trial for maximum tolerated dose level. The drug has also shown potential for use in treating inflammatory pain.

The U.S. Patent and Trademark Office said in a judgement in January 2007 that Purdue was unable to contest priority of invention regarding certain methods of treating pain using compounds that include ralfinamide.

Under the settlement with Newron, Purdue will forgo any judicial review in the United States of the Patent Office's judgement.

Another article by Forbes...
http://www.forbes.com/afxnewslimited...fx3875699.html

[alan]

Hopefully there will be more info re trials.

[adi chicago]

help us god...if neuro pain will be history ...sci will be soon.
i love ab docs who care about us.