Miravant Announces PHOTREX as New Brand Name For SnET2 PDT.SANTA BARBARA, Calif. -- Miravant Medical Technologies (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :MRVT MRVT Materiel Release Verification Test ), a pharmaceutical development company specializing in 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 PacĂfico PDT ), today announced PHOTREX(TM) as the new brand name for SnET2, a proposed PDT drug for the treatment of 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 Company also announced that the United States Adopted Name United States Adopted Names are unique nonproprietary names assigned to pharmaceuticals marketed in the United States. Each name is assigned by the USAN Council, which is co-sponsored by the American Medical Association (AMA), the United States Pharmacopoeial Convention (USP), and Council (USAN USAN United States Adopted Name. USAN abbr. United States Adopted Names (used for nonproprietary names of drugs adopted by a committee of medical professionals and drug manufacturers) USAN ) has designated "rostaporfin" as the drug's unique generic name generic name n. 1. The official nonproprietary name of a drug, under which it is licensed and identified by the manufacturer. 2. . USAN is the agency that assigns generic names to pharmaceuticals. "We believe that PHOTREX is a powerful and distinctive brand name for SnET2 photodynamic therapy," stated Gary S. Kledzik, Ph.D., chairman and chief executive officer. On September 30, 2004, 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. ) issued an approvable letter for PHOTREX outlining the conditions for final marketing approval, which included a request for an additional confirmatory clinical trial. Wet AMD is a degenerative eye disease that can cause severe loss of central vision. 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 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 Cardiovascular disease Disease that affects the heart and blood vessels. Mentioned in: Lipoproteins Test cardiovascular disease and oncology. PhotoPoint PDT uses light-activated drugs to selectively target diseased cells and blood vessels. The Company's lead drug, PHOTREX (rostaporfin), is in development as a treatment for wet age-related macular degeneration. The Company has a development agreement with Guidant Corporation for PDT applications in cardiovascular disease. Safe Harbor Statement 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. Kledzik and other statements about the attributes of the brand name PHOTREX; the potential future use of PHOTREX as a treatment for wet AMD; and the Company's 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 trademark PHOTREX may not become registered; the Company's operating capital may not be sufficient to continue some or all of its development programs, complete the 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 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 and conditions 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 PHOTREX and the degree of acceptance cannot be guaranteed; 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 reports on Form 10-Q for the quarters ended March 31 and June 30, 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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