[The maker of a Visudyne-knock-off candidate for AMD is now working with Guidant on photodynamic therapy (PDT) for arterial plaque. I guess it’s not surprising that PDT would have diverse applications; after all, it began several years ago as a treatment for cancer which didn’t pan out.]
>> Miravant Announces Collaborative Agreement With Guidant in Cardiovascular Disease
Guidant Makes Staged Equity Investment to Fund PhotoPoint PDT Development
SANTA BARBARA, Calif.--(BUSINESS WIRE)--July 6, 2004--Miravant Medical Technologies (OTCBB:MRVT - News), a pharmaceutical development company specializing in PhotoPoint® photodynamic therapy (PDT), today announced a Collaboration Agreement and a Securities Purchase Agreement (SPA) with Guidant Corporation (NYSE:GDT - News), a world leader in the treatment of cardiac and vascular disease, headquartered in Indianapolis, Indiana. Guidant agreed to provide up to $7 million capital in support of Miravant's PhotoPoint cardiovascular programs, including an upfront payment of $3 million and additional staged investments based on the achievement of certain milestones through Phase I clinical trials. The development programs include regional treatments for atherosclerosis and atherosclerotic vulnerable plaque, representing large potential markets. Miravant plans to collaborate with Guidant on clinical development from facilities in Santa Barbara and Indianapolis.
"We are extremely pleased with Guidant's support and endorsement of PhotoPoint PDT as a potential treatment for patients with serious coronary artery diseases," said Gary S. Kledzik, Ph.D., Miravant chairman and chief executive officer. "The benefit of Guidant's experience and consultation should focus our development efforts and help facilitate our progress towards human clinical studies."
"Vulnerable plaque is a silent killer that can cause a heart attack without warning. Guidant is actively pursuing interventional device-based therapies to treat the millions of patients with cardiac and vascular disease who have these potentially deadly lesions," said Dana G. Mead, Jr., president, Vascular Intervention, Guidant Corporation. "We are encouraged by Miravant's preclinical results, and look forward to collaborating with the company to further develop the potential of photodynamic therapy for vulnerable plaque applications."
The preclinical studies for PhotoPoint PDT were conducted under the direction of Ron Waksman, MD, Professor of Medicine (Cardiology), Georgetown University and Associate Chief of Cardiology at the Washington Hospital Center; and analyzed under the direction of Renu Virmani, MD, Chair, Cardiovascular Pathology, Armed Forces Institute of Pathology, Washington DC. Dr. Waksman stated, "PhotoPoint PDT has been shown to be very effective in extensive preclinical studies. If these results can be realized in clinical trials, PhotoPoint PDT could make a dramatic difference in our ability to treat patients with atherosclerosis. We are especially encouraged by the potential to reduce the risk of rupture in vulnerable plaques. My colleagues and I at the Washington Hospital Center look forward to continuing our participation in the evaluation and development of this promising new therapy."
A Form 8-K will be filed with the Securities and Exchange Commission (SEC) within two business days of this release.
Intracoronary PhotoPoint PDT
Miravant is developing PhotoPoint PDT as a minimally invasive interventional procedure for the treatment of patients with coronary artery disease, including atherosclerosis, atherosclerotic vulnerable plaque and restenosis. Currently under preclinical investigation, the catheter-based treatment uses a systemic light-reactive drug in combination with low power, non-thermal light to treat regions of atherosclerotic plaque in blood vessel walls, including vulnerable plaque. Miravant has established a substantial body of preclinical data to support further investigations of this proprietary technology. In March 2004, preclinical results were presented at the American College of Cardiology, New Orleans, which suggest that PhotoPoint PDT may remove inflammatory cells in atherosclerotic plaque, reduce plaque volume and induce positive mechanisms of healing and repair that are consistent with plaque stabilization.
Atherosclerosis and Vulnerable Plaque
Heart attacks strike 1.1 million people in the U.S. each year, leading to 460,000 deaths. Most heart attacks are caused by atherosclerosis, a common vascular disease involving lipid-derived plaques in blood vessel walls. It has been recently recognized that certain inflamed plaques are highly unstable and vulnerable to spontaneous rupture, causing an estimated 85% of heart attacks. Intense research efforts are underway to identify and treat vulnerable plaques before they erupt, estimated by analysts to be a multi-billion dollar market.
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 has filed a New Drug Application (NDA) for the drug SnET2 for the treatment of patients with wet age-related macular degeneration. Miravant's cardiovascular program focuses on life-threatening diseases, with PhotoPoint MV0633 in advanced preclinical testing for atherosclerosis, atherosclerotic vulnerable plaque and restenosis. <<
[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.]
>> 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. <<
Market Data 
Markets 
AI
