>>Miravant's Confirmatory Phase III Clinical Trial of PHOTREX(TM) in Patients with Age-Related Macular Degeneration Is Underway
Monday October 10, 10:00 am ET
SANTA BARBARA, Calif.--(BUSINESS WIRE)--Oct. 10, 2005--Miravant Medical Technologies (OTCBB:MRVT - News), a pharmaceutical development company specializing in PhotoPoint® photodynamic therapy (PDT), today confirmed that patient enrollment is underway in its Phase III clinical trial of PHOTREX(TM) (SnET2) for wet age-related macular degeneration (AMD). This multi-center, placebo controlled study is a confirmatory trial designed to fulfill the requirements for additional clinical data as outlined in an "approvable" letter received from the FDA following its review of the company's NDA submission.
Miravant has contracted with Kendle (Nasdaq:KNDL - News), a leading global full-service clinical research organization, to provide clinical development and trial management services for this trial, which is being conducted at approximately 50 investigational sites in the United Kingdom, Central and Eastern Europe. This randomized, placebo-controlled trial, reviewed by the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA), includes a range of patients with both the classic and occult forms of wet AMD. Miravant expects to conduct a primary efficacy endpoint analysis at 12 months (one year after initial treatment), with a total of approximately 650 patients to be analyzed. At that time, the Company expects to amend its New Drug Application (NDA) to seek marketing approval while patients are followed for a second year.
"Kendle is pleased to have been selected to provide clinical development services for this pivotal Phase III trial," said Alan Boyce, Vice President, Europe, for Kendle. "We look forward to providing Miravant with access to our significant experience and patient access capabilities, both in the Central and Eastern European region and globally."
The FDA granted an approvable status to PHOTREX(TM) in September 2004, which included a request for this confirmatory clinical trial. The new clinical protocol was reviewed by the FDA under a SPA. Wet AMD is a debilitating eye disease that is the leading cause of blindness in older adults.
About Miravant
Miravant Medical Technologies (www.miravant.com) specializes in PhotoPoint® photodynamic therapy (PDT), developing light-activated drugs to selectively target diseased cells and blood vessels. Miravant's primary areas of focus are ophthalmology and cardiovascular disease with new drugs in clinical and preclinical development. PHOTREX(TM) (rostaporfin), the Company's most advanced drug, has received an FDA Approvable Letter as a treatment for wet age-related macular degeneration and a SPA for this Phase III confirmatory clinical trial. Miravant's cardiovascular development program, supported in part by an investment from Guidant Corporation, focuses on life-threatening coronary artery diseases, with PhotoPoint MV0633 in advanced preclinical testing for atherosclerosis, vulnerable plaque and restenosis.
About Kendle
Kendle International Inc. (www.kendle.com) is among the world's leading global clinical research organizations. We deliver innovative and robust clinical development solutions -- from first-in-human studies through market launch and surveillance -- to help the world's biopharmaceutical companies maximize product life cycles and grow market share. With the expertise of our more than 1,800 associates worldwide, Kendle has conducted clinical trials or provided regulatory, pharmacovigilance and validation services in 70 countries. <<
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