-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, WJogkg0rBftdm5jdYXLKIG9fY3kIZtEErQsXEqNfKaZpYFC0Og2Fp3tpfEM2D1ms NMXml+ym0HL1qLOByHhnyg== 0000933745-02-000001.txt : 20020413 0000933745-02-000001.hdr.sgml : 20020413 ACCESSION NUMBER: 0000933745-02-000001 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20020113 ITEM INFORMATION: Other events FILED AS OF DATE: 20020116 FILER: COMPANY DATA: COMPANY CONFORMED NAME: MIRAVANT MEDICAL TECHNOLOGIES CENTRAL INDEX KEY: 0000933745 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 770222872 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-25544 FILM NUMBER: 2510618 BUSINESS ADDRESS: STREET 1: 336 BOLLAY DRIVE CITY: SANTA BARBARA STATE: CA ZIP: 93117 BUSINESS PHONE: 8056859880 MAIL ADDRESS: STREET 1: 336 BOLLAY DRIVE CITY: SANTA BARBARA STATE: CA ZIP: 93117 FORMER COMPANY: FORMER CONFORMED NAME: PDT INC /DE/ DATE OF NAME CHANGE: 19941214 8-K 1 f8kjan2002.txt FORM 8-K - ITEM 5. OTHER EVENTS SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of Report (Date of earliest event reported): January 13, 2002 MIRAVANT MEDICAL TECHNOLOGIES (Exact name of registrant as specified in its charter) Delaware 0-25544 77-0222872 (State or other jurisdiction of (Commission (IRS Employer Identification incorporation) File Number) Number) 336 Bollay Drive Santa Barbara, California 93117 (Address of principal executive offices) (Zip Code) - ------------------------------------------------------------------------ Registrant's telephone number, including area code: (805) 685-9880 N/A (Former Name or Former Address, if Changed Since Last Report) ITEM 5. Other Events On January 13, 2002 we issued a press release announcing the results of our Phase III clinical trials of SnET2, or tin ethyl etiopurpurin, an investigational drug developed for the wet form of age-related macular degeneration, or wet AMD. The top line results of the trials indicate that SnET2 did not meet the primary efficacy endpoint in this study population. The press release is attached as Exhibit 99 to this Form 8-K and is incorporated in this report in its entirety. Item 7. Exhibits Exhibit Number Exhibit Exhibit 99 Miravant Medical Technologies January 13, 2002 Press Release. SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. MIRAVANT MEDICAL TECHNOLOGIES By: /s/ John M. Philpott ----------------------------------- Name: John M. Philpott Title: Chief Financial Officer Date: January 16, 2002 Exhibit Number Exhibit Exhibit 99 Miravant Medical Technologies January 13, 2002 Press Release. EX-99 2 f8kjan2002exb99.txt EXHIBIT 99 - JANUARY 13, 2002 PRESS RELEASE Exhibit 99 MIRAVANT ANNOUNCES RESULTS OF PHASE III STUDY OF SnET2 SANTA BARBARA, CA, January 13, 2002 - Miravant Medical Technologies (Nasdaq: MRVT) announced today the results of its phase III clinical trials of SnET2 (tin ethyl etiopurpurin), an investigational drug developed for the wet form of age-related macular degeneration (wet AMD). The top line results of the trials indicate that SnET2 did not meet the primary efficacy endpoint in this study population. "We have always recognized the challenges of developing a treatment for this serious vision-threatening disease," said Gary S. Kledzik, Ph.D, chairman and chief executive officer. "We will be undertaking a full review of the data from the phase III trials, and will make future development decisions about SnET2 after we have completed the additional analyses." AMD is the leading cause of severe vision loss in people over 50 years of age. The wet form of AMD is the more severe type, affecting only 10 percent of those with the disease, but accounting for 90% of the blindness caused by AMD. There are approximately 400,000 new cases of wet AMD each year in the U.S. and Europe. Miravant developed SnET2 in collaboration with Pharmacia Corporation. SnET2 is an investigational photodynamic therapy (PDT) for sub-foveal choroidal neovascularization (CNV), also known as the wet form of AMD. The phase III trials consist of two randomized, double-masked studies, enrolling a total of 933 patients with wet AMD. Patients were treated with SnET2 (0.5 mg/kg and 0.75 mg/kg, placebo) and a diode laser using 664nm wavelength. Miravant Medical Technologies specializes in both pharmaceuticals and devices for photoselective medicine. The company is developing PhotoPoint(tm) PDT in ophthalmology, dermatology, cardiovascular disease and oncology. The statement above by Dr. Kledzik about future development of SnET2 is forward-looking and relates to our future plans, objectives, expectations and intentions. Our actual results may differ materially from those described in these statements. For instance, the company may decide not to further develop SnET2 for wet AMD or any other indication. 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, 2000 and other quarterly and periodic reports filed with the Securities and Exchange Commission. -----END PRIVACY-ENHANCED MESSAGE-----