July 7, 2004
For Immediate Release

Health Canada approves first-of-its-kind treatment for precancerous skin disease

Patient-applied cream stimulates the body's own immune system to treat disease from within

TORONTO, ON - July 7, 2004 - Health Canada has approved AldaraT (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. 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. Nearly half (45 percent) of the patients treated with Aldara Cream achieved complete clearance of all lesions compared to only 3 percent in the placebo group. The majority of patients experienced lesion clearance of 75 percent 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, 2 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 2 percent of the patients reported pain at the lesion site. While 16 percent of patients had a rest period during treatment, only 2 percent 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 commonly affect the most sun-exposed areas such as head and face. Individuals with fair skin, light hair and light-coloured 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.

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.