Biotech Values

[DewDiligence]

Miravant to run pivotal ex-U.S. trial in AMD

[Some background: MRVT’s AMD treatment, now called Photrex, is a Visudyne knock-off. Miravant submitted an NDA in 2004 based on an earlier phase-3 trial, but the FDA requested more data.

What’s notable here is that MRVT’s new phase-3 trial will be conducted entirely outside the U.S., where Macugen is not yet approved, in order to facilitate enrollment. This should avoid the kind of slow-recruitment problem GENR seems to be having in its placebo-controlled Squalamine trials.]

http://biz.yahoo.com/bw/050202/25394_1.html

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Miravant to Conduct PHOTREX Confirmatory Study for Macular Degeneration

SANTA BARBARA, Calif.--(BUSINESS WIRE)--Feb. 2, 2005--Miravant Medical Technologies (OTCBB:MRVT - News), a pharmaceutical development company specializing in PhotoPoint® photodynamic therapy (PDT), announced today that it will conduct a phase III confirmatory clinical trial of PHOTREX(TM) (rostaporfin, formerly known as SnET2) for wet age-related macular degeneration (AMD), based on a Special Protocol Assessment by the U.S. Food and Drug Administration (FDA). The FDA requested this single confirmatory study in its Approvable Letter issued September 2004, after reviewing the Company's New Drug Application (NDA).

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.

About Miravant

Miravant Medical Technologies specializes in pharmaceuticals and devices for photoselective medicine, developing its proprietary PhotoPoint® 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.
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