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


SANTA BARBARA, Calif. -- Clinical Investigators Report Positive Vision Benefits in Macular Degeneration macular degeneration, eye disorder causing loss of central vision. The affected area, the macula, lies at the back of the retina and is the part that produces the sharpest vision.  Patients

Miravant Medical Technologies (OTCBB OTCBB

See OTC Bulletin Board (OTCBB).
:MRVT MRVT Materiel Release Verification Test ), a pharmaceutical development company specializing in PhotoPoint(R) photodynamic therapy photodynamic therapy
n.
A type of phototherapy in which a nontoxic light-sensitive compound that has been injected into a patient is exposed selectively to light, whereupon it becomes toxic to targeted malignant and other diseased cells.
 (PDT PDT
abbr.
Pacific Daylight Time


PDT Pacific Daylight Time

PDT n abbr (US) (= Pacific Daylight Time) → hora de verano del Pacífico

PDT 
), today announced that proprietary drug SnET2 provided a visual acuity visual acuity
n.
Sharpness of vision, especially as tested with a Snellen chart. Normal visual acuity based on the Snellen chart is 20/20.


Visual acuity
The ability to distinguish details and shapes of objects.
 benefit in macular degeneration patients with occult lesions, as observed in phase III clinical trials of patients with wet age-related macular degeneration Age-related macular degeneration (ARMD)
Degeneration of the macula (the central part of the retina where the rods and cones are most dense) that leads to loss of central vision in people over 60.
 (AMD (Advanced Micro Devices, Inc., Sunnyvale, CA, www.amd.com) A major manufacturer of semiconductor devices including x86-compatible CPUs, embedded processors, flash memories, programmable logic devices and networking chips. ). The clinical results were presented by Edgar L. Thomas, M.D., Los Angeles, at the American Society of Retinal Specialists (ASRS ASRS Aviation Safety Reporting System
ASRS Arizona State Retirement System
ASRS Automatic Storage and Retrieval System
ASRS Automated Storage & Retrieval System
ASRS Adult Self-Report Scale
ASRS Anion Self-Regenerating Suppressor (Dionex) 
) meeting, San Diego. The U.S. Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) is currently reviewing Miravant's New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) 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. The results are encouraging and show that SnET2 may have an effect in occult membranes as well as classic."

Also at ASRS, Baruch Kuppermann, M.D., University of California The University of California has a combined student body of more than 191,000 students, over 1,340,000 living alumni, and a combined systemwide and campus endowment of just over $7.3 billion (8th largest in the United States). , 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 fundus /fun·dus/ (fun´dus) pl. fun´di   [L.] the bottom or base of anything; the bottom or base of an organ, or the part of a hollow organ farthest from its mouth.  Photography Reading Center, Madison, presented angiographic outcomes that showed SnET2-PDT reduced the growth of fluorescein fluorescein /flu·o·res·ce·in/ (fldbobr-res´en) a fluorescing dye; its sodium salt is used as a tracer in retinal angiography and as a diagnostic aid for revealing corneal trauma and fitting contact lenses.  leakage, subretinal fluid, choroidal cho·roi·dal
adj.
Of or relating to the choroid.



choroidal

pertaining to or emanating from the choroid.


choroidal hypoplasia
 neovascularization (CNV CNV Choroidal Neovascularization (eye disorder)
CNV Christelijk Nationaal Vakverbond
CNV Copy Number Variation
CNV Conveyor
CNV Chief of Navy
CNV Continuous Normal Voltage
CNV Crypto Net Variable
CNV Could Not Verify
) 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 ran·dom·ize  
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment.
, 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.

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 an NDA for its leading drug, SnET2, as a treatment of patients with wet age-related macular degeneration, a leading cause of blindness. Miravant's cardiovascular program focuses on life-threatening 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  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. Thomas and other statements about the potential use and benefits of SnET2 to treat wet AMD; the NDA filing of SnET2; and development programs for large potential markets in ophthalmology, dermatology, cardiovascular disease and oncology, 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: the Company's operating capital may not be sufficient to continue some or all of its development programs, complete the NDA review process or continue as a going concern; potential future funding may not be available when needed if at all or under terms acceptable to the Company; the Company may not meet the covenants of the December 2002 Debt Agreement, the August 2003 Convertible Debt and Warrant Purchase Agreement or the February 2004 Debt Agreement, which would give the holders under these agreements the right to call outstanding debt immediately due and payable; the Company may not achieve certain milestones required to receive future investments under the Collaboration Agreement with Guidant; the Company may be unable to resolve all issues or contingencies associated with the NDA; 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, the Company may not have the necessary resources or corporate partnering relationship(s) to commercialize SnET2 and the degree of acceptance of SnET2 cannot be guaranteed; results of cardiovascular preclinical studies may not be indicative of future clinical trials, if and when clinical trials begin; the Company 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 March 31, 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.
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Publication:Business Wire
Geographic Code:1USA
Date:Aug 17, 2004
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