Healthcare Industry News:  5-FU 

Biopharmaceuticals Dermatology

 News Release - April 16, 2008

Graceway Pharmaceuticals Reports Study in British Journal of Dermatology: Patients Treated with ALDARA Experienced Higher Levels of Histological and Sustained Clearance for Actinic Keratosis (AK) than Patients in two Other Common AK Treatments

BRISTOL, Tenn.--(HSMN NewsFeed)--Graceway Pharmaceuticals, LLC today announced the results from a study comparing 3 different treatments for actinic keratosis, a skin condition that can become cancerous if left untreated. This study evaluated three common treatment options: imiquimod 5% cream (ALDARA), topical 5-fluorouracil (5-FU), and cryotherapy. The results of this study demonstrated that patients treated with ALDARA experienced the highest level of histological (biopsy confirmed) clearance among patients in the three treatment arms. In addition, 12 months after treatment, significantly more patients remained disease free with ALDARA than after treatment with cryotherapy or 5-FU. The design and detailed results of this randomized clinical study and additional scientific findings are described below.

"For the first time," according to Dr. Krawtchenko and colleagues, who conducted the research, "three of the most common therapies were compared in this study: cryotherapy, as the most widely used treatment option and representative for surgical methods; topical applied 5-FU, a frequently used method for chemically destroying all types of AK, and [imiquimod (ALDARA), an] alternative that may provide [treatment for] AK by immunostimulation means and observed to have high clearance rates in recent studies."

The study measured clinical and histological outcomes in 75 patients with a minimum of 5 typical, visible, and histologically-proven AK lesions. Patients were randomly assigned to 1 of 3 treatment groups of equal size: cryosurgery (one or two courses; 20-40 seconds per lesion), 5-FU (twice daily for 4 weeks), or ALDARA (three times per week for 4 weeks, 1 or 2 courses), and evaluated after the initial treatment period and again at 12-months follow-up.

Initial clearance rates as assessed by clinical evaluation were 96%, 85%, and 68% for 5-FU, ALDARA, and cryosurgery, respectively (P=0.03). When the clinical assessment was confirmed by biopsy, significantly more patients treated with ALDARA showed initial histological clearance vs 5-FU or cryosurgery (73% vs 67% and 32%, respectively, P=0.008). Of the 85% who clinically cleared on ALDARA, 5 of 22 patients cleared after the first course of treatment and 17 of 22 cleared after the second course of treatment.

A difference in the sustained clearance, measured by the absence of AK lesions 12 months after treatment, was also observed in the study. The sustained clearance rate in ALDARA-treated patients was higher compared to that of 5-FU and cryosurgery patients in both initially cleared lesions (73% vs 54% and 28%, respectively, P<0.01) and clearance of the total field (73% vs 33% and 4%, respectively, P<0.01). The authors elaborated: "It is understandable that a high sustained clearance cannot be achieved by a spot treatment like cryosurgery targeted only at clinically visible lesions [and this may explain] its poor performance . . . . Imiquimod is a nonchemodestructive field treatment that acts selectively on mutated cells by activating the normal immune response. This mode of action may explain the superior sustained clearance rate of 73% [seen in the ALDARA-treated patients]."

Skin cosmetic outcomes were evaluated by both investigators and patients. Although cosmetic outcomes showed no significant difference among the groups at the end of treatment, after 12 months, a significantly higher percentage of patients treated with ALDARA were judged to have excellent cosmetic outcomes, compared with approximately 4% of patients in the cryosurgery and 5-FU groups (P<0.0001).

In terms of safety, mild skin thinning was observed for most of the patients without significant differences between these groups. No serious adverse events occurred in the treatment area through the 12-month follow-up period. One patient refused a second course of ALDARA treatment due to local skin reactions.

The dosing of ALDARA used in this study is not the FDA-approved dosing schedule. The on-label dosing of ALDARA Cream in the treatment of AK is twice weekly for 16 weeks. However, the treatment period should not extend beyond 16 weeks due to missed doses or rest periods. The treatment area should be one contiguous area of approximately 25 cm2 (e.g., 5 cm x 5 cm). ALDARA cream should be applied to the entire treatment area (e.g., the forehead, scalp, or one cheek).

About ALDARA

ALDARA is the brand name for imiquimod, which is an immune response modifier. ALDARA is not chemodestructive or cytotoxic. Safety and efficacy have not been established for ALDARA Cream in the treatment of actinic keratoses with repeated use, i.e., more than one treatment course, in the same 25 cm2 area. The safety of ALDARA Cream applied to areas of skin greater than 25 cm2 (egg, 5 cm x 5 cm) for the treatment of actinic keratoses has not been established.

ALDARA Cream is indicated for the topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp in immunocompetent adults.

When using Aldara Cream, the most common side effects involve skin reactions in the application area. These include redness, swelling, a sore, blisters, or ulcers, skin that becomes hard or thickened, skin peeling, scabbing and crusting, itching, burning, and changes in skin color that do not always go away.

When using Aldara Cream for actinic keratosis, exposure to sunlight (including sunlamps) should be avoided or minimized during use of Aldara Cream because of concern of heightened sunburn susceptibility. Patients should be warned to use protective clothing (hat) when using Aldara Cream.

About Graceway Pharmaceuticals, LLC

Graceway Pharmaceuticals, LLC ("Graceway"), headquartered in Bristol, TN, is a pharmaceutical company focused on acquiring, in-licensing, and developing branded prescription pharmaceutical products. Current prescription products marketed by Graceway include ALDARA® (imiquimod) Cream, 5%, Maxair® Autohaler® (pirbuterol acetate inhalation aerosol), Atopiclair® Nonsteroidal Cream, and Estrasorb® (estradiol topical emulsion). ALDARA®, Maxair®, Autohaler®, Atopiclair®, and Estrasorb® are trademarks owned by or licensed to Graceway. For more information on Graceway's products, including important safety information, please visit www.gracewaypharma.com.

Reference:

Krawtchenko N, Roewert-Huber J, Ulrich M, Mann I, Sterry W, Stockfleth E. A randomized study of topical 5% imiquimod vs. topical 5-fluorouracil vs. cryosurgery in immunocompetent patients with actinic keratoses: a comparison of clinical and histological outcomes including 1-year follow-up. Br J Dermatol. 2007;157(suppl 2):33-39.


Source: Graceway Pharmaceuticals

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