Medarex Announces Enrollment Complete in Ipilimumab (MDX-010) Monotherapy Pivotal Registrational Trial for Metastatic Melanoma
Thursday January 4, 7:00 am ET
- Expected Biologics License Application filing on track for 2007 -
PRINCETON, N.J., Jan. 4 /PRNewswire-FirstCall/ -- Medarex, Inc. (Nasdaq: MEDX - News) today announced that enrollment has been completed in a pivotal, registrational clinical trial evaluating ipilimumab (MDX-010) as monotherapy for the second-line treatment of metastatic melanoma.
"Completion of enrollment for the monotherapy registrational study represents a milestone in the development of ipilimumab and is a testament to the shared enthusiasm and dedication of the Medarex and Bristol-Myers Squibb partnership," said Irwin Lerner, Chairman of the Board of Directors and Interim President and CEO of Medarex. "Both companies are keenly aware of the acute need for new treatment options in this setting. This study is part of a comprehensive clinical development program that we have undertaken to understand the potential for ipilimumab to address this unmet medical need."
About the Monotherapy Registrational Trial
The open label, single-arm, monotherapy registrational clinical trial is designed to evaluate 150 patients with unresectable Stage III or Stage IV advanced melanoma who have progressed after at least one prior regimen of a melanoma treatment other than ipilimumab. Patients will receive a dose of 10 mg/kg of ipilimumab once every three weeks for up to four doses. Subsequently, eligible patients who have not experienced disease progression at week 24 will continue in a maintenance phase where a single dose of ipilimumab will be administered once every 12 weeks until disease progression. The study is designed to assess best objective response rate (complete and partial responses) as the primary endpoint. Secondary endpoints include disease control rate (complete and partial responses plus stable disease), progression-free and overall survival, as well as duration of best objective responses.
In March 2006, the registrational clinical trial was reviewed by the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) concerning the suitability of the trial design to support regulatory approval. In December 2006, the FDA granted Fast Track status to this program which provides for expedited regulatory review for new drugs that demonstrate the potential to address unmet medical needs for the treatment of serious or life- threatening conditions. |
