PPMD's Blog – November 2016 Archive (4)

Summit Enrolls U.S. Patients into Phaseout DMD, a Phase 2 Clinical Trial of Ezutromid in Duchenne

Summit Therapeutics plc announced today that it has enrolled its first patients at trial sites in the US into PhaseOut DMD, a Phase 2 clinical trial of ezutromid in Duchenne. The 48-week, open-label (meaning all participants receive ezutromid) Phase 2 trial is enrolling up to 40 boys total between their 5th…


Added by PPMD on November 16, 2016 at 9:00am — No Comments

CHMP Recommends Renewal of Translarna's™ Marketing Authorization Based on Continued Positive Benefit-Risk Assessment

PTC Therapeutics, Inc. today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the renewal of the conditional marketing authorization of Translarna(TM) (ataluren) for the treatment of nonsense mutation Duchenne muscular dystrophy in ambulatory patients…


Added by PPMD on November 11, 2016 at 9:30am — No Comments

Akashi Provides HT-100 Clinical Trial Update

In February, dosing and new patient enrollment in all cohorts of the HALO trial, a study evaluating the compound HT-100 in patients with Duchenne, was suspended after one of the patients in the trial, receiving 60μg/kg/d (the highest dose in the study), passed away after experiencing serious, life-threatening health issues. Since then, the company has been working with the…


Added by PPMD on November 7, 2016 at 11:30am — No Comments

Pfizer Shares Update on Phase II Clinical Trial of Domagrozumab (PF-06252616) in Duchenne

Pfizer has provided the following update regarding the on-going Phase II clinical trial of domagrozumab (PF-06252616), a myostatin inhibitor, in people with Duchenne.

Notably, the age range for this clinical study has been expanded from 6 to <10 years of age to 6 to <16 years of age. Additional sites have been added in the US, United Kingdom, Poland, Bulgaria, and Australia.

Pfizer also reports that enrollment of the phase 2 study of…


Added by PPMD on November 2, 2016 at 2:30pm — No Comments

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