Wednesday January 12, 5:44 pm Eastern Time
Company Press Release
SOURCE: Micrologix Biotech Inc.
Micrologix successfully completes Phase II clinical trials of
MBI 226 for prevention of bloodstream infections
VANCOUVER, Jan. 12 /CNW-PRN/ - Micrologix Biotech Inc.
Trading Symbol MBI: (TSE/CDNX)
MGIXF (US over the counter)
Micrologix is pleased to announce the successful completion of a US Phase II clinical trial as part of the fast track development program
for MBI 226. The trial, developed in consultation with the US Food & Drug Administration (FDA), was designed to substantiate the safety
of MBI 226, a novel peptide antibiotic for the prevention of central venous catheter-related bloodstream infection. Based on these Phase II
results, Micrologix anticipates initiating Phase III clinical trials in the third calendar quarter of 2000.
In the first part of the Phase II trial, the potential for MBI 226 to elicit an immune response was evaluated in 201 healthy subjects. Using a
modified Draize protocol, each subject was exposed to MBI 226 every second day for a total of 10 applications (Induction Phase).
Following a 14-day period where no drug was applied, each subject was challenged with MBI 226 (Challenge Phase). During the
Induction Phase, MBI 226 caused minimal irritation - a level that was similar to the irritation caused by distilled water, which served as a
negative control. During the Challenge Phase, no sensitization (immune) reaction to MBI 226 was seen. In contrast, the positive control
caused sensitization in 2% of subjects, which is in line with expected outcomes.
In the second part of the trial, the cumulative irritation potential and degree of systemic absorption of MBI 226 were assessed in 37 healthy
subjects. The cumulative irritation resulting from repeated daily exposure to MBI 226 for 14 days was less than that caused by the negative
control, distilled water. In addition, no trace of MBI 226 was detected in blood samples taken from these subjects during the study.
Therefore, MBI 226 does not cause skin irritation and does not result in systemic absorption following topical application.
These Phase II results confirm the data obtained in Phase I and further expand the database demonstrating that MBI 226 is safe and well
tolerated by humans. As a result of being granted fast track status, Micrologix is continuing to work closely with the FDA to finalize the
design of pivotal Phase III studies to determine the efficacy of MBI 226 in preventing catheter-related bloodstream infections in patients.
These studies, anticipated to begin in the third calendar quarter of this year, will form the basis for a New Drug Application to market MBI
226 in the US.
Background on CVC-Related Bloodstream Infections and Phase I Results
Central venous catheters (CVCs) are devices used by physicians to deliver
therapeutic and nutritional agents, sample blood, and monitor a patient's
status. They are commonly inserted through the chest wall into a major vein,
such as the jugular vein. In the US, more than 5 million CVCs are sold each
year. It is estimated that in the US catheter-related bloodstream infections
develop in more than 250,000 patients each year, resulting in 50,000 deaths.
On average, patients with bloodstream infections spend an additional 6.5 days
in intensive care at an extra cost of $29,000 per patient.
The vast majority of CVC-related bloodstream infections occur when bacteria and/or fungi that colonize the patient's skin around the
catheter insertion site migrate down the catheter tract to colonize the implanted portion of the device. These microorganisms then break
away from the colonized catheter, seeding into the blood and causing subsequent bloodstream infections, also known as ``blood
poisoning'. In many cases the organisms that cause these infections have developed resistance to conventional antibiotics. In preclinical
studies MBI 226 was found to be effective against these organisms. In Phase I clinical trials Micrologix demonstrated that MBI 226
reduced the number of microorganisms growing on the skin of healthy subjects by 99.9% and the incidence of catheter colonization to zero.
Micrologix Biotech Inc. is a biopharmaceutical company developing novel drugs to treat severe and life-threatening diseases-particularly
those caused by antibiotic-resistant microorganisms. In addition to MBI 226 for the prevention of central venous catheter-related
bloodstream infections, the Company plans to initiate Phase I trials for acne and a second indication in the first half of 2000. Micrologix's
portfolio of drug candidates is based on improved analogs of the anti-infective peptide compounds found in the host-defense systems of
most life forms.
``Dany Hadary'
---------------
Dany Hadary
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 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 Canadian Venture Exchange have not reviewed and do not accept responsibility for the adequacy or
accuracy of this release.
Investor Relations Contact:
Arthur J. Ayres
Micrologix Biotech Inc.
Telephone: 604.221.9666
Toll-Free: 1.800.665.1968
Fax 604.221.9688
E-mail: info(at)mbiotech.com
Website: www.mbiotech.com
SOURCE: Micrologix Biotech Inc. |
