Miravant (MRVT) To Initiate PHOTREX Confirmatory Phase III Clinical Trial In Europe; Global CRO Kendle Selected To Provide Clinical Development And Trial Management Services
10/19/2005 5:12:59 PM
SANTA BARBARA, Calif.--(BUSINESS WIRE)--March 10, 2005--Miravant Medical Technologies (OTCBB:MRVT), a pharmaceutical development company specializing in PhotoPoint(R) photodynamic therapy (PDT), today announced that it will conduct a confirmatory Phase III clinical trial for PHOTREX(TM) (rostaporfin, formerly known as SnET2) at investigational sites in Central and Eastern Europe (CEE) and the United Kingdom. Miravant has selected Kendle (Nasdaq:KNDL), a leading international contract research organization with locations worldwide, to provide clinical development services for the Phase III trial. The randomized, placebo-controlled study, reviewed by the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment, will evaluate a range of patients with wet age-related macular degeneration (AMD), including both classic and occult lesions.
"Miravant selected Kendle based on its significant Phase III experience and expertise in Europe, particularly its patient access capabilities in CEE," said Gary S. Kledzik, Ph.D., chairman and chief executive officer. "These countries are proving to be desirable locations for conducting pharmaceutical clinical trials, with motivated, cost-effective research centers and high patient productivity. We are confident that Kendle's integrated study teams can efficiently manage the trial and satisfy our strategic regulatory requirements."