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Attention Business Editors:
Micrologix successfully completes Phase I clinical trial for the prevention of bloodstream infections
VANCOUVER, April 27 /CNW/ - Micrologix Biotech Inc.
Trading Symbol:
MBI (TSE/VSE)
MGIXF (US over the counter)
Micrologix Biotech Inc. is pleased to announce that it has successfully
completed a two-part Phase I human clinical trial of MBI 226, its lead
Bactolysin drug candidate for preventing bloodstream infections in patients
undergoing central venous catheterization. The study showed that MBI 226 is
safe and well tolerated, eliminates 99.9% of bacteria commonly found on the
skin and prevents bacterial growth on catheters. We will present these results
to the United States FDA and intend to initiate Phase II clinical trials in
the second half of this year.
The Centers for Disease Control and Prevention in Atlanta estimate that
in the US alone, 200,000 hospital patients contract bloodstream infections
each year. Central venous catheters (CVCs) cause more than 90% of these
infections, and on average, infected patients spend an additional 6.5 days in
intensive care at a cost of $29,000. The associated mortality rate is high: up
to 50,000 patients die annually from these bloodstream infections. As a result
of the serious morbidity and mortality rates associated with these infections,
the FDA announced in September 1998 that it is placing a high priority on
supporting the development and approval of drugs to prevent and treat
bloodstream infections. More effective means of prevention or treatment would
save many lives and billions of dollars in health care costs in North America
alone.
Phase I clinical studies are one of the steps required by the FDA for
approval of a new drug. Representing the first human exposure to a therapeutic
product, Phase I clinical studies assess a drug's safety, metabolism and
pharmacology. In addition to these standard tests, the FDA allowed Micrologix
to conduct a study to assess the antimicrobial effectiveness of MBI 226.
With Quintiles, a leading global clinical research organization, we
conducted a randomized, double-blind, placebo-controlled trial in 18 healthy
volunteers. In the safety and pharmacology portion of the Phase I study,
either MBI 226 or a placebo was topically applied daily for five days at the
insertion site of intravenous catheters in 12 subjects. MBI 226 was found to
be safe, non-irritating and well tolerated: no drug related adverse effects
were noted. Moreover, there was no evidence of systemic absorption of MBI 226
as no product was detected in the blood. Finally, MBI 226 did not produce an
immune response when the subjects were exposed to the drug after a 14-day
washout period.
In the efficacy portion of the Phase I study, we compared the
antimicrobial activity of MBI 226 to a placebo control in six healthy
volunteers. The goal was to assess, over a period of three days, the effect of
a single application of MBI 226 or placebo on the bacteria and fungi normally
found on human skin. MBI 226 reduced the number of microorganisms on the skin
surface by more than 99.9% compared to the placebo control. This level of
killing and suppression was maintained for three days following a single
application of MBI 226. This is very significant, because in clinical
practice, physicians do not routinely change the dressings on intravenous
catheters more often than once every two to three days. MBI 226's ability to
greatly suppress the flora at catheter insertion sites is of major importance
as there is a strong correlation between microbial growth on the skin and the
risk of catheter-related bloodstream infection.
The design of the Phase I study also allowed us to assess the
effectiveness of MBI 226 in preventing the growth (or colonization) of
bacteria and fungi on the surfaces of implanted intravenous catheters,
particularly those surfaces that had been in contact with the patient's blood.
After the safety study, the catheters were tested for bacterial and fungal
growth. Microorganisms colonized the intravenous catheters of 83% of the
subjects in the placebo control group (five of six subjects). In contrast, no
colonization was detected on the catheters removed from all six subjects
treated with MBI 226.
''The vast majority of CVC-related bloodstream infections result from two
sequential events -bacteria or fungi colonize the skin around the catheter
insertion site then migrate down the catheter tract to colonize the implanted
portion of the device,'' says Dr. Dennis Maki, Chair of Micrologix's Clinical
Advisory Board. ''The results from Micrologix's Phase I study demonstrate that
MBI 226 is safe and may prove effective for preventing central venous catheter
colonization. These findings are very significant, because central venous
catheter colonization is highly correlated with subsequent bloodstream
infections. Micrologix's approach to the prevention of CVC-related bloodstream
infections may prove to be an important advance particularly since, in
contrast to conventional antimicrobials, bacterial resistance has not been
inducible with MBI 226. Additionally, it will be straightforward to
incorporate the topical use of this agent into current clinical practice.''
Based on the positive Phase I results, Micrologix is preparing a
regulatory submission to the FDA and plans to initiate Phase II trials in the
second half of 1999. Phase II clinical trials are the first controlled studies
measuring a drug's effectiveness in its intended use. There are no drugs
currently approved by the FDA for the treatment or prevention of CVC-related
bloodstream infections. As such, we have been working closely with the FDA and
our Clinical Advisory Board on the design of the Phase II study.
Micrologix Biotech Inc. is a biopharmaceutical company developing novel
drugs to treat severe and life-threatening diseases. The Company has a broad
portfolio of drug candidates based on improved analogs of the anti-infective
peptide compounds found in the host-defense systems of most life forms. These
compounds are targeted at serious infectious diseases - particularly those
caused by antibiotic-resistant microorganisms - as well as cancer and other
diseases. In addition to its first product, MBI 226, Micrologix has lead
candidates for the treatment of acne and eye infections in preclinical
development.
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
always use the words ''expects'', ''anticipates'', ''suggests'', ''plans'',
''believes'' or ''intends'', or similar words and/or include statements
concerning the Company's strategies, goals and plans, or state that certain
actions, events or results ''will'' be taken, occur or be achieved. These
forward-looking statements involve known and unknown risks, uncertainties and
other factors which may cause the actual results, performance or achievement
of the company, or industry results, to be materially different from any
future results, performance or achievements expressed or implied by such
statements. Such 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.
The Toronto Stock Exchange and the Vancouver Stock Exchange have not
reviewed and do not accept responsibility for the adequacy or accuracy of this
release.
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For further information: Arthur J. Ayres (604) 221-9666, Toll-Free
1-800-665-1968, Fax (604) 221-9688, E-mail info@mbiotech.com, Website
www.mbiotech.com
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