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Data Demonstrate Zyclara (Imiquimod) Cream, 3.75% Greatly Improves Efficacy of Cryosurgery in Reducing Actinic Keratoses (AK)

BRISTOL, Tenn.--(BUSINESS WIRE)--Aug 6, 2010 - Results from a randomized study with Zyclara following cryotherapy in the treatment of actinic keratoses (AK) demonstrated Zyclara complemented the effectiveness of cryosurgery in reducing total AK count and achieving complete clearance of AK, according to data presented at the American Academy of Dermatology Summer Academy Meeting 2010 (Summer AAD), August 4 – 8. The study found that Zyclara used after cryosurgery produced greater lesion reduction than cryosurgery alone across all measures including doubling the proportion of patients with complete clearance from 30 percent to 60 percent in the cryosurgery-treated area.

Cryosurgery is the most commonly used treatment for AK patients, with studies finding that more than 75 percent of patients with AK are treated only with cryosurgery. However, a limitation of cryotherapy is that it can only be used to treat visible AK lesions. To further research the clinical utility of a more comprehensive treatment strategy, the study evaluated the safety and efficacy of employing a field-directed treatment that could be used across the full face (Zyclara) in a patient population with extensive disease following a lesion-directed treatment (cryosurgery).

Zyclara produced statistically significant median lesion reductions across all measures. Median lesion reductions were 86.5 percent versus 50 percent for total AKs, 100 percent and 80 percent for cryosurgery-treated AKs and 83.3 percent and 22.2 percent for AKs not treated with cryosurgery, for Zyclara and placebo, respectively.

“Cryosurgery is the most prevalent treatment used to remove AK lesions, but as more of our patients present with more lesions, we are constantly looking for ways to improve treatment outcomes,” said Joseph Jorizzo, M.D., Professor, Department of Dermatology, Wake Forest University. “This study – one of the largest, blinded, prospective clinical studies involving cryosurgery – suggests a clinical benefit of adding Zyclara to the patient population which undergoes cryosurgery.”

According to a meta-analysis using Zyclara's prior AK studies, the safety profile of Zyclara used after cryosurgery was comparable to Zyclara as a monotherapy. The most commonly reported adverse events were application site reactions, with application site pruritis (9.5 percent on Zyclara versus 0 percent on placebo), irritation (5.6 percent on Zyclara versus 0.8 percent on placebo) and pain (4.8 percent on Zyclara versus 0 percent on placebo) being the most frequent. Rest periods were required by 21.4 percent of Zyclara and 0 percent of placebo patients. The discontinuation rate due to adverse events, in the Zyclara arm of the study was similar to that in the placebo arm.

“Not only did we find that Zyclara greatly enhanced the efficacy of cryosurgery to reduce the number of lesions,” said Jefferson J. Gregory, Chairman and CEO of Graceway® Pharmaceuticals. “But by evaluating patients for 20 weeks post-treatment, we were able to expand upon previous studies, and generate promising data about the sustained durability of Zyclara's efficacy versus cryosurgery alone.”

About the studies

In the study, 260 adults underwent cryosurgery of 5 – 14 AKs, leaving approximately 5 AKs untreated for reference. Following cryosurgery, the remaining 247 subjects were randomized to receive Zyclara or placebo. Participants had a median lesion count of 14 prior to cryosurgery. At week 26, primary efficacy of a reduction in AK count from baseline was assessed, along with secondary efficacy of complete clearance, photodamage assessments and investigator and subject satisfaction.

For the 247 subjects randomized, the mean age was 66.7 years, 214 (86.6 percent) were male, the mean total pre-cryosurgery AK count was 16.0 and mean AKs treated with cryosurgery was 6.6. Of the 126 and 121 subjects randomized to Zyclara and placebo,112 (88.9 percent) and 111 (91.7 percent) completed the study, and 4 (3.2 percent) and 5 (4.1 percent) discontinued early for safety reasons, respectively.

Median lesion reductions were 86.5 percent and 50.0 percent (p<.0001) for total AKs, 100 percent and 80.0 percent (p=.0008) for cryosurgery-treated AKs, and 83.3 percent and 22.2 percent (p<.0001) for non-cryosurgery-treated AKs, for Zyclara and placebo, respectively.

Secondary outcome measures included complete clearance, photodamage assessments and investigator and subject satisfaction. Complete clearance for total AKs were 30.2 percent and 3.3 percent (p<.0001), 59.5 percent and 29.8 percent (p<.0001) for cryosurgery-treated AKs, and 34.1 percent and 5.0 percent (p<.0001) for non-cryosurgery-treated AKs, for Zyclara and placebo, respectively.

More subjects in the Zyclara group than the placebo group experienced statistically significant improvements in photodamage assessments of the face, including global photoaging (51.6 percent on Zyclara versus 19.3 percent on placebo), fine lines (32.8 percent on Zyclara versus 15.1 percent on placebo), mottled pigmentation (46.7 percent on Zyclara versus 18.5 percent on placebo) and tactile roughness (61.5 percent on Zyclara versus 22.7 percent on placebo). More subjects in the Zyclara group than the placebo group were considered by investigators and by the subjects to have had a satisfactory treatment outcome, with 70.2 percent of subjects on Zyclara versus 31.1 percent of subjects on placebo reporting excellent satisfaction. Additionally, 72.1 percent versus 16.8 percent of investigators reported excellent satisfaction on Zyclara and placebo, respectively.

The most commonly reported adverse events were application site reactions, with application site pruritis (9.5 percent on Zyclara versus 0 percent on placebo), irritation (5.6 percent on Zyclara versus 0.8 percent on placebo) and pain (4.8 percent on Zyclara versus 0 percent on placebo) being the most frequent. Rest periods were required by 21.4 percent of Zyclara and 0 percent of placebo patients.

About Actinic Keratosis

AK is a sign of sun damage resulting from long-term exposure to harmful UV rays. The sun's rays cause changes in the size, shape, and organization of the top layer of skin cells, also known as the epidermis, and just below it. These cellular mutations can then form AKs.

AK is considered a pre-cancer and may often be confused with age spots, eczema or psoriasis. AKs are small, red, sometimes scaly or rough patches that can be found on skin most often exposed to the sun like the face, bald scalp, hands, shoulders and arms. AKs can vary in shape and color, ranging from red to light or dark tan, pink, or a combination of these. These lesions may range from the size of a pinhead to larger than a quarter and may feel dry and rough like sandpaper. In the beginning, AKs can be so small that they are often identified by their rough texture rather than by sight.

Some AKs may develop into a serious form of skin cancer called squamous cell carcinoma, or SCC. If left unchecked, this cancer can spread to other areas of the body and organs. Because it is difficult to predict whether an AK will develop into cancer, it is important to discuss any changes in your skin with a doctor.

About Zyclara™ (imiquimod) Cream, 3.75%

Zyclara Cream is a prescription medicine for use on the face or balding scalp only (a topical medicine) to treat actinic keratosis (AK). Do not use Zyclara cream in or on your eyes, nostrils, mouth or vagina.

When using Zyclara Cream, the most common side effects involve skin reactions in the application area. These include redness, scabbing or crusting, flaking, scaling or dryness, swelling, sores or blisters, and draining (weeping).

When using Zyclara Cream do not use sunlamps or tanning beds, and avoid sunlight as much as possible. Use sunscreen and wear protective clothing if you go outside during daylight.

For more information on Zyclara, visit www.ZyclaraCream.com.

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. Graceway has acquired or licensed products from 3M (NYSE: MMM), Pfizer (NYSE: PFE) and Gilead (NASDQ: GILD). Current prescription products marketed by Graceway include Zyclara™ (imiquimod) Cream, 3.75%, Aldara® (imiquimod) Cream, 5%, Maxair®Autohaler® (pirbuterol acetate inhalation aerosol), Atopiclair® Nonsteroidal Cream, and Estrasorb® (estradiol topical emulsion). Zyclara™, 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.

Contact: Chamberlain Healthcare Public Relations
Glenn Silver, 212-884-0646
gsilver@chamberlainpr.com

 

Posted: August 2010

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