To: Pete who wrote (416 ) 2/3/1999 4:13:00 AM From: Graham Dellaire Respond to of 792
Micrologix Plans to Initiate Clinical Trials for the Treatment of Acne VANCOUVER, Feb. 2 /CNW/ - Micrologix Biotech Inc. Trading Symbol: MBI (TSE/VSE) MGIXF (US over the counter) Micrologix's Bactolysins (cationic antimicrobial peptides) offer significant potential to treat severe inflammatory acne, as shown by recent results from the Company's preclinical program. Currently, many strains of bacteria associated with acne are highly resistant to the traditional antibiotics used to treat this disease. Micrologix has been developing Bactolysins that are highly active against these strains and is currently selecting candidates for further studies. The Company plans to initiate clinical trials for the treatment of acne in the first quarter of 2000. Acne is the most common inflammatory skin disease of adolescence and early adulthood. Nearly 20% of all visits to dermatologists are related to its evaluation and treatment. While not life-threatening, the characteristic papules, nodules and pustules occurring on the face, neck and upper body of acne sufferers can persist for years and have serious adverse psychosocial effects including depression and withdrawal from society. By conservative estimates, acne affects 17 million people in the US alone. The US market for prescription anti-acne medications is approximately $1.2 billion annually. Current therapy for severe acne includes topical antibiotics and the use of systemic antibiotics approved for other indications. Yet increasing resistance to these antibiotics is severely limiting their use. Topical and systemic retinoids (derivatives of vitamin A) have recently entered clinical practice as a treatment for moderate to severe acne. However, these compounds, particularly in systemic form, can have significant side effects and have been shown to cause birth defects if taken during pregnancy. The most important bacterium associated with acne is Propionibacterium acnes, with secondary infection due to Staphylococcus aureus and Staphylococcus epidermidis. Antibiotic resistance in P. acnes strains -- and in the other bacteria associated with acne -- has been reported worldwide. In fact, the overall incidence of antibiotic resistant P. acnes has dramatically increased from 20% in 1978 to 62% in 1996. Strains of acne-causing bacteria now resist both systemic and topical forms of erythromycin, one of the most widely prescribed antibiotics. ''We're running out of options,'' says Dr. James Leyden, professor of dermatology at the University of Pennsylvania School of Medicine, a world-renowned expert in acne therapy and an advisor to Micrologix. ''We estimate that at least one out of four acne patients is infected with strains of P. acnes that are resistant to tetracycline, erythromycin and clindamycin. And these strains also show lower susceptibility to minocycline and doxycycline than in the past.'' Micrologix's Bactolysins offer significant potential for the effective treatment of severe acne. Results from our preclinical research program demonstrate that Bactolysins are non-toxic and non-irritating in animal models. In addition, the superior activity of Bactolysins against resistant strains of acne-causing bacteria suggests that these agents may be more effective than currently available antibiotics. Most importantly, unlike conventional antibiotics, Bactolysins kill microorganisms such as bacteria by destroying their cellular membranes, thus preventing bacteria from developing resistance to Bactolysin compounds. For these reasons, Bactolysins are considered to be strong drug candidates for the treatment of severe inflammatory acne. The Company is proceeding with additional preclinical testing of several of its lead Bactolysins and plans to initiate clinical trials in the first quarter of 2000. Micrologix Biotech Inc. is a biopharmaceutical company developing novel drugs to treat severe and life-threatening diseases. The Company's broad 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. These compounds are targeted at serious infectious diseases -- particularly those caused by antibiotic resistant microorganisms -- as well as cancer and other diseases. Micrologix's first product, for the prevention of bloodstream infections associated with central venous catheters, is in Phase I clinical studies. Lead candidates for the treatment of eye infections and acne are 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.