The placebo-controlled trial, to be conducted outside of the United States, is designed to enroll a broad range of wet AMD patients, including patients with predominantly classic, minimally classic and occult lesions. According to the protocol, each study patient will receive PHOTREX (or placebo) treatments over the course of nine months. The Company currently plans to conduct a primary efficacy endpoint analysis at 12 months (one year after initial treatment) which, pending positive results, will be submitted for FDA review and subsequent marketing approval. Patients will continue to be evaluated for a second year to confirm the longer-term results established in previous PHOTREX phase III studies. Miravant expects to commence patient enrollment in mid-2005.
"I am pleased to update the market on our plans to move forward with the PHOTREX clinical trial after our discussions with the FDA," said Gary S. Kledzik, Ph.D., chairman and chief executive officer. "The trial will be used to confirm the results of two pivotal studies that suggested PHOTREX could stabilize vision in a range of patients with this debilitating eye disease."
Dr. Kledzik added, "We are also planning to initiate additional studies of PHOTREX PDT in combination with other therapeutic agents for wet AMD, reflecting current trends in clinical practice where we expect photodynamic therapy to be a mainstay procedure."
Wet AMD is a major health problem with an estimated 500,000 new cases each year worldwide. The disease is characterized by abnormal blood vessels at the back of the eye that leak fluid and blood and can lead to retinal scarring and severe loss of central vision. PHOTREX PDT uses a light-activated drug intended to selectively destroy these abnormal blood vessels and stabilize vision loss.
Miravant Medical Technologies specializes in pharmaceuticals and devices for photoselective medicine, developing its proprietary PhotoPoint(R) photodynamic therapy (PDT) for large potential markets in ophthalmology, dermatology, cardiovascular disease and oncology. PhotoPoint PDT uses photoreactive (light-activated) drugs to selectively target diseased cells and blood vessels. The Company's lead drug, PHOTREX(TM), is in clinical development as a treatment for wet age-related macular degeneration and has received an Approvable Letter from the U.S. Food and Drug Administration. Miravant's cardiovascular program focuses on life-threatening coronary artery diseases, with PhotoPoint MV0633 in advanced preclinical testing for atherosclerosis, atherosclerotic vulnerable plaque and restenosis.
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 Dr. Kledzik and other statements about commencing a confirmatory phase III clinical trial and other combination studies; the timing and duration of the clinical trial and the measurement periods relating thereto; the primary efficacy endpoint analysis at 12 months; potential FDA approval to market PHOTREX PDT; continued use of PDT as a mainstay procedure in clinical practice; the efficacy of PHOTREX PDT; and development programs for large potential markets in ophthalmology, dermatology, cardiovascular disease and oncology 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 clinical trial(s) and NDA review process or continue as a going concern; we may be unable to resolve all issues or contingencies associated with the NDA and the Approvable Letter; the FDA may require further clinical or non-clinical studies before granting 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 and its degree of acceptance cannot be guaranteed; we may decide not to or may be unable to further develop its PhotoPoint drugs in ophthalmology, dermatology, cardiovascular disease and/or oncology; the Company may not be able to demonstrate the safety or efficacy of its 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, 2003, our quarterly report on Form 10-Q for the quarter ended September 30, 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.