Tuesday, October 5, 2004

ALDARA PROVES TO BE EFFECTIVE ACTINIC KERATOSIS TREATMENT IN RECENT STUDY

New study findings suggest that 3M's Aldara (imiquimod) cream 5% administered three times per week for 16 weeks appears to be an effective treatment for actinic keratosis.

Study authors evaluated the efficacy of Aldara among patients with histologically confirmed actinic keratosis. The cohort consisted of otherwise healthy subjects with five to nine clinically diagnosed and histologically confirmed actinic keratosis lesions on the face or balding scalp.

All subjects were randomized to receive either Aldara (n=147) or a vehicle cream (n=139) three days per week. A prestudy period was followed by the 16-week treatment period and an eight-week post-treatment period.

The primary efficacy variable was the complete clearance rate at the eight-week post-treatment visit. This clearance rate was defined as the proportion of subjects with no evidence of actinic keratosis on the histology result of the target lesion biopsy site and no clinically visible actinic keratosis in the treatment area.

The outcomes demonstrated that the complete clearance rate for the treatment group was 57.1 percent versus 2.2 percent in the vehicle group. The authors noted that the difference in complete clearance rates (Aldara minus vehicle) was 55.0 percent. Furthermore, the partial clearance rates were 72.1 percent and 4.3 percent for the treatment and vehicle groups, respectively. The difference in partial clearance rates (Aldara minus vehicle) was 67.8 percent.

Adverse events were reported by 70.7 percent of the treatment arm and 48.2 percent of the vehicle arm. The most frequent side effects included erythema, scabbing/crusting and erosions/ulcerations.

"The complete histologic clearance of actinic keratosis lesions observed in this study confirms that treatment with [Aldara] eliminates all abnormal cells, not just the visible portion of the actinic keratosis lesion," the researchers concluded.

The study was published in the October issue of the Journal of the American Academy of Dermatology.

Wednesday, September 22, 2004

ALDARA TREATMENT LEADS TO ANTITUMOR RESPONSE, COMPLETE REMISSION OF MOST BASAL CELL CARCINOMAS, RECENT TRIAL SUGGESTS

New study findings show 3M's pharmaceutical brand name cream, Aldara (imiquimod) Cream 5%, induced an antitumor immune response and resulted in the complete remission of 74 percent of treated basal cell carcinomas (BCC) after two years.

The open-label trial included 55 white patients with primary BCCs of 8 mm or more in diameter and superficial, nodular or infiltrative histological patterns. Thirty-five of the BCCs were treated with Aldara three times per week, while the other 20 BCCs were treated with Aldara five times each week. Histological samples were obtained before, during and six weeks after treatment; patients were followed for more than two years.

The results showed that among the treated BCCs, 41 were in complete remission after two years, including all four of the superficial BCCs, 88 percent of the nodular BCCs and 70 percent of the infiltrative BCCs.

According to multivariate analysis, baseline tumor size was the most important independent prognostic variable.

The study appeared in the September issue of Clinical and Experimental Dermatology.

Friday, July 16, 2004

ALDARA CREAM APPROVED FOR SUPERFICIAL BASAL CELL CARCINOMA

The Food and Drug Administration approved 3M's proprietary brand name cream, Aldara (imiquimod) Cream 5%, for the treatment of biopsy-confirmed, primary superficial basal cell carcinoma (sBCC) among adult patients with normal immune systems.

Specifically, the cream is indicated to treat sBCC tumors with a maximum diameter of 2 cm, on certain body areas, when surgical methods are less appropriate and when patient follow-up is reasonably assured.

In April, 3M said it had received an approvable letter concerning Aldara from the FDA, asking for additional safety information. The firm said it planned to quickly submit the requested data from completed clinical studies.

Final approval was based on results from two trials including a total of 364 patients with biopsy-confirmed primary sBCC tumors. They were treated with Aldara or placebo cream five times per week for six weeks.

Twelve weeks after treatment, 75 percent of Aldara-treated patients had achieved composite clearance, or clearance based on both biopsy and visual inspection, and 82 percent had attained histological, or biopsy-confirmed, clearance. In the placebo group, the composite clearance rate was 2 percent, while histological clearance occurred in 3 percent of patients.

SBCC is a type of nonmelanoma skin cancer that, like the precancerous skin condition actinic keratosis, is caused by chronic sun exposure. Aldara has also been approved to treat external genital and perianal warts as well as certain types of actinic keratosis.

Friday, May 21, 2004

TWO PHASE III STUDIES SUGGEST ALDARA CREAM 5% EFFECTIVE FOR ACTINIC KERATOSIS TREATMENT

When used twice weekly for 16 weeks, 3M Pharmaceuticals' proprietary brand name cream, Aldara (imiquimod) cream 5%, appears to be well tolerated and effective for treating actinic keratosis, according to two Phase III studies.

Combined, the trials included 436 patients with four to eight actinic keratosis lesions on the face or balding scalp. For 16 weeks, the patients applied Aldara or a vehicle cream once per day for two days each week. There was then an eight-week treatment-free follow-up period.

The primary efficacy variable, defined as the proportion of patients with no clinically visible actinic keratosis lesions at the eight-week post-treatment visit, was achieved by 45.1 percent of the Aldara-treated patients and 3.2 percent of the patients who received the vehicle cream.

The Aldara and vehicle-cream groups also demonstrated partial clearance (at least 75 percent) rates of 59.1 percent and 11.8 percent, respectively.

By the eight-week post-treatment visit, the number of baseline actinic keratosis lesions dropped a median 83.3 percent in the Aldara arm versus 0 percent in the vehicle-cream arm.

The adverse events reported most often by both treatment groups were application site reactions. Overall, Aldara was well tolerated, but severe erythema was reported by 17.7 percent of patients receiving the pharmaceutical drug compared with 2.3 percent of patients receiving the vehicle cream.

The study is published in the May edition of Journal of the American Academy of Dermatology.

Thursday, April 15, 2004

FDA ISSUES APPROVABLE LETTER FOR NEW ALDARA INDICATION

3M Pharmaceuticals received an approvable letter from the Food and Drug Administration regarding a supplemental New Drug Application for its proprietary brand name cream, Aldara Cream (imiquimod) 5%, to be used to treat superficial basal cell carcinoma, a form of non-melanoma skin cancer.

While the regulatory agency recognized no major deficiencies in the application, it did say that approval is conditional upon the firm's provision of additional safety data. 3M plans to soon submit the data from already completed clinical studies.

The FDA's review of these results could take up to six months, so 3M expects the sNDA may be approved in the second half of 2004.

Aldara has already been approved to treat genital warts and actinic keratosis, a pre-cancerous skin disease caused by cumulative sun exposure.

Tuesday, May 6, 2003

3M SUBMITS SNDA FOR ALDARA CREAM

3M Pharmaceuticals filed a supplemental New Drug Application with the Food and Drug Administration to market Aldara (imiquimod), a proprietary pharmaceutical cream for the treatment of actinic keratosis.

Aldara is currently indicated for external genital and perianal warts. It represents the first immune-response modifier for which a marketing application has been submitted for an actinic keratosis indication.

3M said it is also on track to submit an sNDA for Aldara in the treatment of superficial basal cell carcinoma, a common type of non-melonoma skin cancer.

The pharmaceutical company said its recent application was based on positive results from two double-blind, randomized, placebo-controlled trials that involved 436 patients with multiple actinic keratoses. Patients were treated with Aldara or placebo cream twice per week for 16 weeks.

Eight weeks after treatment, one-half of the patients treated with Aldara had at least an 83 percent reduction in the number of actinic keratosis lesions versus 0 percent in the placebo group.

Also, 45 percent of patients treated with Aldara had complete clearance of actinic keratosis versus 3 percent of those given placebo.

Actinic keratosis lesions are caused by cumulative sun exposure and often appear as rough, red, scaly patches, crusts or sores on the skin, 3M said. The skin condition affects as many as 10 million Americans each year.