To: Taff who wrote (397 ) 2/2/1999 5:34:00 PM From: don jackson Respond to of 792
Micrologix Plans to Initiate Clinical Trials for the Treatment of Acne 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.