Biotech Values

[DewDiligence]

Miravant releases more AMD data... or does it?

[Miravant had previously reported limited two-year data at ARVO (#msg-2957661) and today’s PR offers little additional info. If you’re looking for the hard data on the number of patients who gained or lost a given number of lines, it’s not here. Essentially, this PR says, “Trust us, the data are good.”

As a reminder, Miravant’s treatment, which has an NDA pending with the FDA, is a Visudyne-like photodynamic therapy which uses a laser to activate the drug in the retina.]

http://biz.yahoo.com/bw/040817/175652_1.html

>>
Clinical Results for Miravant's SnET2 Presented at American Society of Retinal Specialists

Clinical Investigators Report Positive Vision Benefits in Macular Degeneration Patients

SANTA BARBARA, Calif.--(BUSINESS WIRE)--Aug. 17, 2004-- Miravant Medical Technologies (OTCBB:MRVT - News), a pharmaceutical development company specializing in PhotoPoint® photodynamic therapy (PDT), today announced that proprietary drug SnET2 provided a visual acuity benefit in macular degeneration patients with occult lesions, as observed in phase III clinical trials of patients with wet age-related macular degeneration (AMD). The clinical results were presented by Edgar L. Thomas, M.D., Los Angeles, at the American Society of Retinal Specialists (ASRS) meeting, San Diego. The U.S. Food and Drug Administration (FDA) is currently reviewing Miravant's New Drug Application (NDA) for SnET2, under a Priority Review designation.

Dr. Thomas said, "We conducted subgroup analyses of the phase III clinical data by lesion composition. In both mixed (classic and occult) lesions and pure occult lesions, we observed a positive treatment response in SnET2-treated patients versus placebo patients. This vision benefit was statistically significant for patients with both predominantly occult and pure occult AMD lesions.[“Predominantly occult” is the same subgroup as “minimally classic,” which is the more commonly used appellation.] The results are encouraging and show that SnET2 may have an effect in occult membranes as well as classic." [Note the use of the word “may.”]

Also at ASRS, Baruch Kuppermann, M.D., University of California, Irvine, presented the visual acuity efficacy results of the phase III clinical trials, concluding that SnET2-PDT SnET2 significantly reduced the risk of vision loss in drug-treated AMD patients versus placebo patients consistently over a two year follow-up. The average number of treatments was 2.8 per patient, with 85% occurring during the first 9 months, suggesting a shorter treatment regimen is beneficial in most patients.

Ronald P. Danis, M.D., University of Wisconsin Fundus Photography Reading Center, Madison, presented angiographic outcomes that showed SnET2-PDT reduced the growth of fluorescein leakage, subretinal fluid, choroidal neovascularization (CNV) and total lesion area relative to placebo at all time points during the two-year studies. Vessel leakage and fluid accumulation are considered to be indicative of disease activity in patients with macular degeneration, and these angiographic assessments support the positive visual acuity outcome.

Carl Regillo, M.D., Wills Eye Hospital, Philadelphia PA, presented safety results of the phase III clinical trials, which demonstrated that the SnET2 treatments were well tolerated in the elderly study population with a very low overall incidence of treatment-related adverse events.

Phase III Clinical Trials

The clinical data are derived from two randomized, placebo-controlled, parallel group phase III studies conducted at 60 U.S. ophthalmology centers of patients with CNV associated with wet AMD. Patients were followed for two years and evaluated for re-treatment every 13 weeks. Two drug doses were tested, and 0.5mg SnET2/kg was determined to be the more efficacious. The Per Protocol study population received the minimum exposure to the 0.5 mg SnET2/kg treatment regimen pre-specified in the clinical protocol and is the basis of the Company's NDA submission.

Wet AMD

Wet AMD is a vision-threatening disorder characterized by the growth of abnormal blood vessels (subfoveal choroidal neovascularization, or CNV) at the back of the eye. CNV lesions leak fluid and blood that can lead to severe loss of central vision. SnET2-PDT uses a light-activated drug designed to selectively destroy the abnormal blood vessels and stabilize vision loss. Based on the proposed labeling in the NDA submission, if approved, SnET2 could potentially be the first drug approved for the entire range of classic AMD lesions, both predominantly and minimally classic, with or without occult component. It is estimated that over the next five years, 1.35 million people within the U.S. will develop wet AMD, with similar numbers outside the U.S.
<<