[swampboots: MVRT did not disclose the percentage of patients with *improved* vision in today’s PR –only the percentage with *improved or stable* vision, which was 58% on therapy and 42% on placebo, measured at two years. Since the percentage of patients with improved vision wasn’t reported, it’s reasonable to infer that it was minuscule to nil. (I am using the standard definitions of these terms as described in #msg-2955983.)
I consider MRVT’s drug to be merely a Visudyne knock-off and not bona fide competition for Squalamine and the other anti-angio/VTA drugs.]
>> Miravant's SnET2 Positively Impacts the Disease Process in Macular Degeneration Patients
Tuesday April 27, 2:03 pm ET
Phase III Clinical Results Presented at Key Ophthalmology Conference
SANTA BARBARA, Calif.--(BUSINESS WIRE)--April 27, 2004--Miravant Medical Technologies (OTCBB: MRVT), a pharmaceutical development company specializing in PhotoPoint® photodynamic therapy (PDT), today announced that investigational drug SnET2 provided a visual acuity benefit and slowed the progression of problematic neovascular lesions in two independent phase III clinical trials of patients with wet age-related macular degeneration (AMD). The clinical results were presented by SnET2 clinical investigators at the Association for Research in Vision and Ophthalmology (ARVO) meeting, Ft. Lauderdale. In March 2004, Miravant submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking marketing approval for the SnET2 treatment.
Edgar L. Thomas MD, Los Angeles, presented two-year visual acuity outcomes in the per protocol study population, which forms the basis of Miravant's NDA submission. Dr. Thomas said, "SnET2 provided a consistent visual acuity benefit over placebo early in the course of treatment and at all time points over two years. It is interesting to note that very few treatments were required to achieve this outcome, and the results were demonstrated in all lesion compositions, regardless of percent classic or occult components. I believe that SnET2 can be a valuable first-line therapy for a broad range of AMD patients."
Ronald P. Danis MD, 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 the resultant subretinal fluid accumulation are considered to be indicative of disease activity in patients with macular degeneration," Dr. Danis stated. "I believe it is very important that the SnET2 treatment clearly reduced these physiologic processes. The angiographic assessments support the primary visual acuity outcome that SnET2 significantly reduced the risk of vision loss in drug-treated AMD patients versus placebo patients."
Carl Regillo MD, Wills Eye Hospital, Philadelphia PA, presented safety results in the total study population. Dr. Regillo concluded, "SnET2 demonstrated an excellent safety profile. The treatments were well tolerated in study population, with a very low overall incidence of treatment-related adverse events."
Key results presented at the ARVO conference are summarized below:
• In two independent clinical studies, the SnET2 treatment showed equivalent, statistically significant visual acuity (VA) benefit compared to placebo at two years, as assessed by the proportion of patients losing less than 15 letters on a standardized ETDRS eye chart (primary efficacy analysis). Pooled results from the two phase III studies (231 SnET2-treated patients vs. 119 placebo patients) demonstrated that SnET2-PDT reduced the risk of visual acuity loss relative to placebo in patients with subfoveal CNV lesions secondary to AMD (58% SnET2 vs. 42% placebo, p less than 0.005). [These are the percentages of patients with improved or stable vision, as defined in message # (#msg-2955983).] • Secondary efficacy analyses were statistically significant and supported the primary analysis. Treated patients demonstrated better VA outcomes in terms of mean change from baseline and reduced severe vision loss (greater than 30 letters). • In other analyses, treatment response was demonstrated across all CNV lesion compositions, regardless of percent classic or occult components. • Treatment response was also demonstrated across all visual acuity (VA) strata, particularly patients with higher baseline VA, suggesting that vision can be stabilized at higher VA levels without the need for watchful waiting. • Maximal treatment response was observed with a regimen of 3 treatments over the first 6 to 9 months, a finding that may provide a useful re-treatment guideline for retinal specialists. • SnET2-PDT significantly impacted CNV lesion characteristics, reducing the physiologic processes of neovascular leakage and fluid accumulation relative to placebo. • The most common side effect was a transient dermal photosensitivity (skin sensitivity to sunlight), occurring in 4.9% SnET2 infusions vs. 1.1% placebo infusions. The majority of reports were mild and transient in nature, resulting in a mild erythema (reddening) of the skin of short onset and duration that resolved without treatment. There were no serious adverse events related to photosensitivity.
Phase III Studies
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. … About Miravant
Miravant Medical Technologies specializes in the development of 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. In 2004, the Company submitted its first NDA for approval of SnET2-PDT to treat patients with wet AMD, a leading cause of blindness in older adults. <<
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