Marinus Pharmaceuticals Initiates Phase IIb Study of Ganaxolone for Adult Partial Seizures BRANFORD, Conn., May 4 /PRNewswire/ -- Marinus Pharmaceuticals, Inc., a specialty pharmaceutical company focused on novel drugs to treat serious neurological disorders, today announced that it is enrolling patients in an international, multi-center, placebo controlled Phase IIb study of its lead compound, Ganaxolone, as an adjunctive treatment in adults suffering from partial onset seizures. This marks the second indication for which Marinus is evaluating Ganaxolone. Ganaxolone is also currently being evaluated in a separate Phase IIb study in infants suffering from Infantile Spasms (also called West syndrome).
"Our goal for this study is to demonstrate that Ganaxolone is a valuable addition to the therapeutic choices available for patients who continue to have seizures even when taking other anticonvulsant drugs," said Harry H. Penner, Jr., Chairman and Chief Executive Officer of Marinus. "We believe that the combination of strong evidence in the scientific literature of Ganaxolone's efficacy in epilepsy and our new proprietary formulation makes Ganaxolone a solidly viable anticonvulsant drug candidate."
Information concerning patient participation in both Marinus studies evaluating Ganaxolone can be found later in this release.
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 (patients who continue to have seizures even when taking multiple anticonvulsant drugs). In a placebo controlled adult epilepsy trial, adverse events in subjects receiving Ganaxolone were similar to those in subjects receiving placebo.
In December, 2006, Marinus successfully completed a performance study of a proprietary new liquid suspension formulation of Ganaxolone designed by Marinus specifically for its Phase IIb studies.
Clinical Study Participation -- Adult Partial Seizures
Clinical Study Participation -- Infantile Spasms
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.
SOURCE Marinus Pharmaceuticals, Inc.