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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.
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(Exact name of Registrant)
700 Bay Street, Suite 1000, Toronto ON, Canada M5G 1Z6
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(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|
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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."
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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
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Name: Jeffrey D. Sherman
Title: Vice President, Finance and C.F.O.
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