- - --------------------------------------------------------------------------------
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|
- - --------------------------------------------------------------------------------
<PAGE>
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
<PAGE>
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
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
<PAGE>
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
