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Stay Granted in Muscular Dystrophy Clinical Trial Case

Friday, September 19, 2008 12:38 PM

The U.S. Court of Appeals for the Third Circuit has granted PTC Therapeutics’ request for a stay of the Federal District Court’s decision on August 20 that would have forced the biotech company to provide its experimental drug PTC124 to 16-year-old Duchenne muscular dystrophy patient Jacob Gunvalson outside its clinical trial process.

According to a statement, PTC “believes allowing individual exceptions at this stage of the drug development process could hinder the drug’s approval.”

The Third Circuit also granted PTC’s motion for an expedited appeal of the lower court’s ruling.

Gunvalson’s parents brought a lawsuit against PTC Therapeutics because they claim the company had promised them that their son could participate in a 96-week clinical trial of PTC124, even though he was not able to participate in the 28-day preliminary phase of the clinical trial due to exclusion criteria. The company claims no such promise was made.

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