Marinus Pharmaceuticals Initiates Phase IIb Study of Ganaxolone for Infantile Spasms
- Category: Small Molecules
- Published on Thursday, 01 March 2007 02:00
- Hits: 2242
BRANFORD, CN, USA | Feb 28, 2007 | Marinus Pharmaceuticals, Inc., a specialty pharmaceutical company focused on novel drugs to treat serious neurological disorders, today announced the dosing of the first patient in an international, multi-center, randomized Phase IIb study of its lead compound, ganaxolone, in infants suffering from Infantile Spasms (also called West syndrome), an indication for which the company has received an Orphan Drug designation from the U.S. Food and Drug Administration (FDA).
"Infantile Spasms is a comparatively rare but catastrophic form of epilepsy for which no drugs are currently approved in the U.S.," said Harry H. Penner, Jr., Chairman and Chief Executive Officer of Marinus. "We are genuinely excited by the prospect of helping the infant children and their families afflicted by this devastating seizure disorder."
In the 1990's, ganaxolone was administered to more than 700 healthy adult volunteers and patients, 214 in Phase I studies, and 498 in Phase II epilepsy and migraine studies. The epilepsy studies involved more than 100 patients and generated data supportive of ganaxolone's efficacy and safety in the treatment of both children and adults suffering from refractory epilepsy. In a placebo controlled adult epilepsy trial, adverse events were similar to placebo. In December, 2006, Marinus successfully completed a performance study of a proprietary new liquid suspension formulation of ganaxolone designed by Marinus specifically for the pediatric population.
Clinical Study Participation
Marinus is a new specialty pharmaceutical company dedicated to the reformulation, development, and commercialization of novel drugs to treat serious neurological, psychiatric, and pain disorders. Marinus is located in Branford, Connecticut and financed by Domain Associates, Canaan Partners, Sofinnova Ventures, and Foundation Medical Partners. For additional information, please visit the company's website at www.marinuspharma.com.
CONTACT: Harry H. Penner, Jr., Chairman & CEO, Marinus Pharmaceuticals,Inc., +1-203-315-0566 x-5211; Rhonda Chiger, +1-917-322-2569, or media: PatGarrison, +1-917-322-2567, both of Rx Communications Group, for MarinusPharmaceuticals, Inc.
SOURCE: Marinus Pharmaceuticals, Inc