-----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, Lgs54F1ip5gIOSL2HbxSLYdbtgNIol174IqDJGpTH30EpMPzVdLAIp2zCeXugOhc bCiM47/uR6H9/MQFftq13w== 0001005477-99-000466.txt : 20010524 0001005477-99-000466.hdr.sgml : 20010524 ACCESSION NUMBER: 0001005477-99-000466 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 19990228 FILED AS OF DATE: 19990211 FILER: COMPANY DATA: COMPANY CONFORMED NAME: VISIBLE GENETICS INC CENTRAL INDEX KEY: 0001010819 STANDARD INDUSTRIAL CLASSIFICATION: 3826 IRS NUMBER: 000000000 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 6-K SEC ACT: SEC FILE NUMBER: 000-28550 FILM NUMBER: 99532016 BUSINESS ADDRESS: STREET 1: 700 BAY ST STREET 2: SUITE 1000 CITY: TORONTO ONTARIO CANA STATE: A6 BUSINESS PHONE: 2127025700 MAIL ADDRESS: STREET 1: 700 BAY ST STE 1000 STREET 2: TORONTO ONTARIO CANADA CITY: M5G 1Z6 6-K 1 FORM 6-K - - -------------------------------------------------------------------------------- SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Issuer PURSUANT to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 Filing No. 1 for the month of February, 1999 Visible Genetics Inc. --------------------- (Exact name of Registrant) 700 Bay Street, Suite 1000, Toronto ON, Canada M5G 1Z6 ------------------------------------------------------ (Address of principal executive offices) Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F Form 20-F |x| Form 40-F |_| Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934. Yes |_| No |X| - - -------------------------------------------------------------------------------- VISIBLE GENETICS INC. The Company has announced that on the recommendation of the Data Safety Management Committee for its VIRADAPT study, the control arm of the study has been stopped on ethical grounds. All patients will now be treated using genotyping information to direct their drug treatment. This decision was made as a result of the publication of a U.S.-based study conducted by the Community Programs for Clinical Research on AIDS ("CPCRA"), "A Pilot Study of the Short-Term Effects of Antiretroviral Management Based on Plasma Genotypic Antiretroviral Resistance Testing ("GART") in Patients Failing Antiretroviral Therapy", by J.D. Baxter, D.L. Mayers, D.N. Wentworth, J.D. Neaton, T.C. Merigan and the CPCRA 046 Study Team. Study results show that patients treated in the GART genotyping arm of the study had a 1.1 log decrease in the viral load with 50% of the patients having undetectable viral loads at 8 weeks versus a 0.65 log decrease and 23% with undetectable viral load, for the non-genotyping arm. These results are consistent with the Company's recently reported VIRADAPT results. The VIRADAPT study, sponsored by the Company, is a randomized, controlled clinical trial carried out at Centre Hospitalier Universitaire de Nice, under the direction of Professor Pierre Dellamonica, an infectious disease specialist. Three sites and five physicians are involved in the trial which monitors 108 total patients. All patients participating in the study have reached the six-month point. The results were first reported at the 4th International Congress on Drug Therapy in HIV Infection, Glasgow Scotland in November 1998 and are almost identical to the GART study results. On or about January 27, 1999, the Company issued a press release with respect to the foregoing. The Company hereby incorporates by reference the text of this Form 6-K (but not the Exhibit hereto) into the Company's Registration Statements on Form F-3 (File Nos. 333-6760 and 333-68939). Exhibit 1. Press release - "Visible Genetics Inc. Halts Control Arm in VIRADAPT Genotyping Trial." 2 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, thereunto duly authorized. VISIBLE GENETICS INC. Date: February 11, 1999 By: /s/ Jeffrey D. Sherman ------------------------------------- Name: Jeffrey D. Sherman Title: Vice President, Finance and C.F.O. 3 EX-99.1 2 PRESS RELEASE -- VISIBLE GENETICS INC. EXHIBIT 1 [LOGO] Visible Genetics Inc. - - -------------------------------------------------------------------------------- For Immediate Release Contacts: David Sassoon (212) 527-7453 Bruno Maruzzo (416) 813-3271 Rowland-Wang Healthcare Visible Genetics Inc. Roanne Argyle (416) 968-7311 Argyle Rowland Worldwide VISIBLE GENETICS HALTS CONTROL ARM IN VIRADAPT GENOTYPING TRIAL - U.S. Based Prospective Genotyping Trial, GART, Corroborates VIRADAPT Study Results - TORONTO, CANADA (January 27, 1999) Visible Genetics Inc. (VGI, Nasdaq: VGIN) announced today that on the recommendation of the Data Safety Management Committee for the VIRADAPT study, the control arm of the study has been stopped on ethical grounds. All patients will now be treated using genotyping information to direct their drug treatment. This decision was made as a result of the publication of a U.S.-based study conducted by the Community Programs for Clinical Research on AIDS (CPCRA), "A Pilot Study of the Short-Term Effects of Antiretroviral Management Based on Plasma Genotypic Antiretroviral Resistance Testing (GART) in Patients Failing Antiretroviral Therapy", by J.D. Baxter, D.L. Mayers, D.N. Wentworth, J.D. Neaton, T.C. Merigan and the CPCRA 046 Study Team. The GART data will be formally presented at the late breaker session on Thursday February 4th 1999 at the 6th Annual Conference on Retroviruses and Opportunistic Infections being held in Chicago. Study results show that patients treated in the GART genotyping arm of the study had a 1.1 log decrease in the viral load with 50% of the patients having undetectable viral loads at 8 weeks, versus a 0.65 log decrease and 23% with undetectable viral load, for the non-genotyping arm. These results are consistent with VGI's recently reported VIRADAPT results. "It would be unethical to continue to treat patients in the control arm of the trial using the current standard of care in light of this new information", said John Stevens, Chairman and CEO of VGI. "Both the VIRADAPT and GART trials have demonstrated that HIV genotyping has the potential to be a useful tool in the treatment of HIV positive patients. Further work and confirmation is obviously required, but these corroborative results are extremely encouraging." Research has shown that HIV is a highly polymorphic (genetically variable) virus that constantly mutates within infected individuals. The virus is so variable that it is unlikely that HIV viruses isolated from any two patients will have the same DNA sequence. Because of this rapid mutation rate, drugs used to treat the HIV infection, while often effective for a period of time, eventually lose efficacy to newly mutated drug resistant HIV. Development of such resistant HIV strains frequently leads to the return of high virus levels in the patient. The GART and VIRADAPT studies are intended to address whether by genotyping HIV, it is possible to treat individual patients by selecting drugs to which the virus has not yet developed resistance, and thus maintain the virus at low levels. The VIRADAPT study, sponsored by Visible Genetics, is a randomized, controlled clinical trial carried out at Centre Hospitalier Universitaire de Nice, under the direction of Professor Pierre Dellamonica, an infectious disease specialist. Three sites and five physicians are involved in the trial which monitors 108 total patients. All patients participating in the study have reached the six-month point. The results were first reported at the 4th International Congress on Drug Therapy in HIV Infection, Glasgow, Scotland in November 1998 and are almost identical to the GART study results. Visible Genetics Inc. manufactures and markets high performance automated DNA sequencing systems and complete kits for the analysis of genes linked to disease. The Company's OpenGene(TM) system employs proprietary stratified DNA testing and single-tube, single-step sequencing methods to significantly reduce the time and cost involved in identifying clinically relevant genetic information. VGI is a leader in the emerging field of pharmacogenomics, which will use genetic information in the identification and analysis of genes in order to improve patient care and reduce healthcare costs. ### 2 -----END PRIVACY-ENHANCED MESSAGE-----