Attention Business Editors:
Micrologix Completes Enrollment for Acne Phase II Clinical Trial
Two-thirds of Subjects have Completed Treatment
Trading Symbol
TSE: MBI
US OTC: MGIXF
Website: www.mbiotech.com
VANCOUVER, Aug. 1 /CNW/ - Micrologix Biotech Inc. today announced that it
has completed the planned enrollment of 75 subjects for the company's Phase II
clinical trial in the United States for MBI 594AN, a novel drug candidate for
the treatment of acne. Of the 75 patients enrolled, 55 have already completed
treatment. The last subjects should complete treatment in mid-September, with
results from the trial expected before the end of November 2001.
"We are pleased to be on-target with clinical development of this
promising drug candidate that has the potential to overcome the serious
problems of resistance seen with many of the currently used anti-acne
antibiotics," said Dr. David Friedland, Vice President, Clinical Development
of Micrologix. "In addition, recent pre-clinical findings of significant anti-
inflammatory activity for our peptides provide further strong support for the
anti-acne activity of MBI 594AN. We look forward to reporting the results of
this Phase II study by the end of November."
The Phase II trial is a randomized, double-blind, placebo-controlled,
dose-ranging study. Patients are being treated daily for six weeks with either
a placebo or one of two dose levels of MBI 594AN. Although the treatment
duration is not designed for a statistical determination of efficacy, the anti-
acne activity is being gauged by acne lesion counts and physician assessment
of each patient, in order to provide a preliminary indication of efficacy.
Safety and tolerability of MBI 594AN will also be assessed in this Phase II
trial.
Background on Acne and Previous Clinical Trial Results
Acne is the most common inflammatory skin disease of adolescence and
early adulthood, with nearly 20% of all visits to dermatologists related to
its evaluation and treatment. It is estimated that approximately 45 million
Americans are affected by acne (US 1996 Census), with the US market for anti-
acne prescription drugs expected to approach approximately US$1.2 billion by
2002. While not life-threatening, the characteristic papules, nodules, and
pustules of acne can persist for years and have serious adverse psychosocial
effects, including depression and withdrawal from society.
For more than 30 years, antibiotic drugs have been used extensively for
the treatment of acne. They are believed to exert their therapeutic effect by
reducing the population of the bacterium Propionibacterium acnes (P. acnes)
and its mediators of inflammation, as well as by producing a direct anti-
inflammatory effect in the case of certain antibiotics. The primary concern
over the use of antibiotics for treating acne is the emergence of resistant
organisms. Published studies indicate that the overall incidence of antibiotic-
resistant P. acnes has increased from 20% in 1978 to 62% in 1996. In addition,
the FDA has recently expressed real concern over the side effects associated
with oral retinoid drugs used to treat acne.
Phase I clinical trials of MBI 594AN demonstrated it to be safe, well
tolerated and to have antimicrobial activity against the acne causing
bacterium, P. acnes.
About Micrologix
Micrologix develops novel drugs targeted at severe and life-threatening
diseases - particularly those caused by antibiotic-resistant bacteria. The
Company's portfolio of antibiotic drug candidates is based on improved analogs
of naturally occurring cationic peptides found in the host defense systems of
most life forms. Micrologix currently has two drugs in clinical trials in the
United States: MBI 226 for preventing catheter-related bloodstream infections
in Phase III and MBI 594AN for treating acne in Phase II. The Company's common
shares are included in the TSE 300 Composite Index.
"W. J. Foran"
-----------------------------
William J. (Bud) Foran
Chairman, President and CEO
The foregoing news release contains forward-looking statements within the
meaning of the United States Private Securities Litigation Reform Act of 1995.
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factors include, among others, those described in the Company's annual report
on Form 20-F, including the following: uncertainties related to early stage of
development, technology and product development; dependence on future
corporate collaborations; dependence on proprietary technology and uncertainty
of patent protection; management of growth; future capital needs and
uncertainty of additional funding; intense competition; manufacturing and
market uncertainties; government regulation; product liability exposure and
insurability.
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For further information: Investor & Media Relations Contacts: Art Ayres,
Micrologix Biotech Inc., Telephone: (604) 221-9666, Toll-Free: 1-800-665-1968,
E-mail: aayres@mbiotech.com; Marla Gale, Fleishman-Hillard Canada Inc.,
Telephone: (416) 214-0701 Fax: 416.214.0720 E-mail: galem@fleishman.com;
Website www.mbiotech.com
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