MRVT Miravant Medical Technologies (CE)

Miravant Medical Technologies (OTCBB:MRVT), a pharmaceutical development company specializing in PhotoPoint(R) 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), 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(R) 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. Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995 The statements contained in this press release that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities and Exchange Act of 1934, as amended, including but not limited to those by Alan Boyce, and other statements about the timing, commencement and parameters of the confirmatory Phase III clinical trial in Europe are forward-looking and relate to our future plans, objectives, expectations and intentions. Our actual results may differ materially from those described in these statements. For instance, the occurrence of one or more of the following may cause our results to differ from our plans: our operating capital may not be sufficient to continue some or all of our development programs, complete the PHOTREX(TM) confirmatory Phase III clinical trial, complete the NDA review process or continue as a going concern; we may not meet the covenants of the December 2002 Debt Agreement or the August 2003 Convertible Debt and Warrant Purchase Agreement, or which would give the holders under these agreements the right to call outstanding debt immediately due and payable; we may not achieve certain milestones required to receive future investments under our Collaboration Agreement with Guidant Corporation; we may be unable to resolve all issues or contingencies associated with the NDA; the FDA may require further clinical or non-clinical studies before granting PHOTREX(TM) marketing approval, or may limit labeling claims, or may not grant marketing approval at all; even if approved, we may not have the necessary resources or corporate partnering relationship(s) to commercialize PHOTREX(TM) and its degree of acceptance cannot be guaranteed; we may decide not to or may be unable to continue the Company's current development programs; we may not be able to demonstrate the safety or efficacy of our drugs in development or achieve their regulatory approvals; and/or partnering discussions may not progress or may not provide the funding and support the Company needs. For a discussion of additional important risk factors that may cause our results to differ from those described above, please refer to our annual report on Form 10-K for the year ended December 31, 2004, and other quarterly and periodic reports filed with the Securities and Exchange Commission. Our products require regulatory approval before marketing, sales or clinical use. PhotoPoint(R) is a registered trademark of Miravant Medical Technologies. PHOTREX(TM) is a trademark of Miravant Medical Technologies.