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Health Canada approves first-of-its-kind treatment for precancerous skin disease
Patient-applied cream stimulates the bodys own immune system to treat disease from within - 3M PHARMACEUTICALS
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TORONTO, July 8 2004 - Health Canada has approved Aldara(TM) (imiquimod) Cream 5%, a topical prescription medication for the treatment of actinic keratosis (AK) - a precancerous skin condition caused by chronic sun exposure affecting at least 1 million Canadians each year(1). If left untreated, AK can develop into squamous cell carcinoma, a common skin cancer.
Aldara Cream is the first new treatment for AK approved in Canada in over 25 years. The cream can be applied at home by the patient, and is the first in a new class of medications called immune response modifiers. Aldara Cream works by triggering the body's immune system to find and kill mutated cells that form, or comprise of, AK.
"Aldara represents an exciting advance because it enhances the body's ability to fight damaged cells from within, versus burning or freezing them from the outside," says Dr. Charles Lynde, Dermatologist, President of the Canadian Dermatology Association, and Assistant Professor at the University of Toronto. "Aldara is safe and effective and offers patients a non-invasive treatment option with good cosmetic outcomes."
In double-blind, randomized, placebo-controlled clinical trials involving 436 patients with multiple AK lesions, patients were treated with Aldara Cream or placebo once a day, twice a week, for 16 weeks(2). Nearly half (45 per cent) of the patients treated with Aldara Cream achieved complete clearance of all lesions compared to only three per cent in the placebo group. The majority of patients experienced lesion clearance of 75 per cent or more.
The study also demonstrated that Aldara Cream detects and treats subclinical disease. Meaning, it treats lesions that are not yet visible, but exist beneath the surface of the skin.
In addition to Aldara Cream, other treatment options include cryotherapy (freezing), excisional surgery, curettage (scraping), electrodessication (drying), lasers (burning), and topical chemotherapy.
"If you can spot AK, you can stop it," comments Dr. Lynde. "It's important to be familiar with one's skin and to see a dermatologist if any growth, mole or discolouration appears suddenly or begins to change - especially given that we can't predict which AK lesions could develop into skin cancer."
Aldara Cream is applied once a day, two days per week for 16 weeks, unless otherwise directed by a physician. In clinical trials, the most frequently reported local skin reactions included redness / flaking / scaling / dryness and itching / burning at the application site. Only two per cent of the patients reported pain at the lesion site. While 16 per cent of patients had a rest period during treatment, only two per cent discontinued treatment due to local skin or application-site reactions. Scarring was not reported as a result of Aldara Cream.
3M Canada manufactures Aldara Cream, which was first approved by Health Canada in 2000 for the treatment of external genital and perianal warts, caused by the human papillomavirus (HPV).
Health Canada is currently reviewing a 3M Aldara Cream submission for the treatment of superficial basal cell carcinoma.
Actinic Keratosis
Actinic keratosis appears as rough, red, scaly patches, or crusts on the skin and if left untreated can progress to squamous cell carcinoma - a form of non-melanoma skin cancer. Actinic keratosis lesions usually measure less than one-quarter inch in diameter and more than 80 per cent of lesions occur on the upper limbs, head and neck. Individuals with fair skin, light hair and light-colored eyes are at the greatest risk for developing AK. The condition usually appears first in adults' aged 40 and up, but much of the damage is done before the age of 18(3).
According to the Canadian Cancer Society, the incidence of non-melanoma skin cancers per year increased from an estimated 40,000 in 1989 to an estimated 68,000 in 2000.
About 3M Canada
3M Pharmaceuticals, a division of 3M Canada Company, develops, manufactures and sells prescription drug products related to dermatology, sexual health, and respiratory conditions. 3M Canada Company employs over 1,800 people across Canada and had annual sales exceeding $1 billion (CDN) in 2002. Additional information is available at www.3m.ca
Worldwide, 3M Company is a $16 billion (US) diversified technology company with leading positions in industrial, consumer, office, health care, safety and electronics, telecommunications and other markets.
3M and Aldara are trademarks used under license in Canada.
B-roll coordinates:
DATE OF FEED:
July 7th, 2004
TIME OF FEED:
1:30 - 2:00pm (13:30 - 14:00) Eastern Standard Time
Continuous Loop
COORDINATES:
Anik E2RC Band, Transponder 8B, audio subcarriers 6.2/ 6.8.
Down link frequency 4020
References:
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(1) Calculated estimate: according to the American Academy of Dermatology, actinic keratosis affects as many as 10 million Americans each year - Canada represents approximately 10 per cent of the American population = 1 million Canadians
(2) Lebwohl et. Al. Imiquimod 5% cream for the treatment of actinic keratosis: Results from two phase III, randomized, double-blind, parallel group, vehicle-controlled trails. J Am Acad Dermatol. 2004; 50:714-721
(3) American Academy of Dermatology, Skin Care Physicians: Actinic Keratoses Net. Available at http://www.skincarephysicians.com/actinickeratosesnet/whatAre.htm (accessed June 30, 2004)
For More Information Contact :
For further information:
3M PHARMACEUTICALS
Environics Communications:
Sacha Tynan
(416) 969-2716
stynan@environicspr.com
Vanessa Eaton
(416) 969-2713
veaton@environicspr.com
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