Not entirely unexpected but MBI better come up with some other hard results quick or
this one is headed south.
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Micrologix Announces Results of Phase Ib Trial for MBI 853NL
Releases New Anti-Inflammatory Data Promising for Acne Program
Trading Symbol: TSE: MBI
US OTC: MGIXF
Website: www.mbiotech.com
VANCOUVER, July 16 /CNW/ - Micrologix Biotech Inc. today announced that
based on the analysis of data from the Phase Ib trial of MBI 853NL for
preventing hospital-acquired Staphylococcus aureus (S. aureus) infections and
projected future clinical trial requirements, the Company has decided not to
proceed to a Phase II efficacy study. Micrologix will instead focus its
resources on other products in its pipeline, including two more clinically
advanced and promising products: MBI 594AN for the treatment of acne (Phase
II) and MBI 226 for the treatment of catheter-related bloodstream infections
(Phase III). Micrologix also announced new preclinical data that shows
significant anti-inflammatory activity for its peptides, which further
supports MBI 594AN in the treatment of acne.
MBI 853NL Phase Ib Results
The Phase Ib trial was a randomized, double-blind, placebo-controlled
study to assess the safety and tolerability of MBI 853NL applied intranasally
to healthy volunteers who were persistent carriers of nasal S. aureus. Data
from the study found that MBI 853NL was safe, well tolerated and resulted in a
decreased number of S. aureus organisms in all MBI 853NL-treated groups.
"While the suspension of the MBI 853NL program comes as a disappointment,
the data confirms that the product is safe and reduces the number of S. aureus
organisms following treatment," said William (Bud) Foran, Chairman and Chief
Executive Officer of Micrologix. "Based on the level of reduction seen and our
experience in screening subjects for this trial, we believe that the future
clinical development program for MBI 853NL would involve greater risk, time
and costs than we can justify. We will now focus our resources on our later-
stage products that are more promising and carry greater near-term market
potential. We will also accelerate the development of additional pre-clinical
compounds based on our proprietary platform technology."
Anti-Inflammatory Properties of MBI Peptides Promising for Acne Program
and Other Dermatological Applications
Acne is the most common inflammatory skin disease of adolescence and
early adulthood. New preclinical data demonstrate that Micrologix's peptides
have significant anti-inflammatory properties. In an in vivo animal model of
hypersensitivity (allergic reaction), MBI's peptides showed a marked reduction
in the inflammatory response, similar to that of hydrocortisone, which is
acknowledged to be a potent anti-inflammatory agent. This important property
strengthens the data to support that MBI 594AN, currently in a Phase II
clinical trial, will be effective in treating acne. Previously, the Company
has reported preclinical and clinical data on the antibacterial properties of
MBI 594AN, including activity against antibiotic-resistant strains of
Propionibacterium acnes - the most important bacterium associated with acne.
In addition to acne, this data suggests that MBI's peptides hold promise for
treating other dermatological conditions.
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 clinical trials and MBI 594AN for treating acne in Phase II. The
Company's common shares are included in the TSE 300 Composite Index.
(signed)
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William J. (Bud) Foran
Chairman, President & CEO
The foregoing news release contains forward-looking statements within the
meaning of the United States Private Securities Litigation Reform Act of 1995.
All statements other than statements of historical fact may be deemed to be
forward-looking statements. Forward-looking statements frequently, but not
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Company's strategies, goals and plans, or state that certain actions, events
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which may cause the actual results, performance or achievement of the company,
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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
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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
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