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New Study Shows Zyclara (Imiquimod) Cream, 3.75% Significantly Improves Efficacy of Cryosurgery in Reducing Actinic Keratoses

LONDON, ON, Sept. 29 /CNW/ - Results from a randomized, double-blinded, placebo-controlled, multicentred study just published in the Journal of Drugs in Dermatology shows that treating Actinic Keratoses (AK) with imiquimod 3.75% (Zyclara®) following cryotherapy was more effective than cryotherapy alone in reducing total AK lesion count and achieving complete clearance of AK. The study found that cryotherapy followed by imiquimod 3.75% (Zyclara®) produced greater lesion reduction across all measures including doubling the proportion of patients with sustained complete clearance from 30 per cent to 60 per cent in the cryotherapy-treated area.1

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).

These study results demonstrate that combining the two treatment modalities provides additional therapeutic benefits to cryotherapy alone.

"The results of this study are relevant because they could mean a change in the way AK is managed, providing physicians a combination therapy that targets AK lesions in two distinct ways," said Dr. Marc Bourcier, study author and Assistant Professor in clinical teaching, Faculty of Medicine, Sherbrooke University. "Visible lesions only are treated with cryotherapy, while multiple lesions and those AK's below the skin's surface are treated using Zyclara® to get at the underlying disease. The combination therapy not only enhances the efficacy of cryotherapy to reduce the number of lesions, but it also promotes sustained clearance."

Actinic Keratoses are considered to be the earliest stage in the development of skin cancer and have the potential, if left untreated, to progress to squamous cell carcinoma (SCC), the second most common form of non-melanoma skin cancer.2 Not long ago in December 2009, Health Canada approved Zyclara®, a topical cream for the treatment of multiple AKs located on the face or balding scalp in adults. In a short course of therapy, Zyclara® is used once daily for up to two weeks, then off for two weeks, and two weeks back on, unless otherwise directed.

"This study adds to the growing body of evidence to support the efficacy and safety of Zyclara® for field treatment," said Dr. Bourcier. "Also, with a shortened course of therapy, Zyclara® offers a more simplified treatment regimen than imiquimod 5% and is also now an effective, safe and non-invasive complement to cryotherapy."

About the Studyi

In the study, 260 adults underwent cryotherapy of 5 - 14 AKs, leaving approximately 5 AKs untreated for reference. Following cryotherapy, the 247 subjects that remained in the study were randomized to receive imiquimod 3.75% (Zyclara®) or placebo. All participants had a median lesion count of 14 prior to cryotherapy. 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.

The study showed when applied once-daily to the full face for two 2-week cycles, separated by a 2-week no-treatment interval, following cryotherapy, Zyclara® produced statistically significant median lesion reductions compared to placebo across all measures. Median lesion reductions were 87 percent versus 50 percent for total AKs. Complete clearance for total AKs were 30 per cent and 3 per cent for Zyclara® and placebo, respectively.

For cryosurgery-treated AKs, media lesion reductions were 100 per cent and 80 per cent for Zyclara® and placebo respectively. As well, sustained complete clearance for cryosurgery-treated AKs was 60 per cent and 30 per cent 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, fine lines, mottled pigmentation and tactile roughness. 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 per cent of subjects on Zyclara® versus 31.1 per cent of subjects on placebo reporting excellent satisfaction. Additionally, 72.1 per cent versus 16.8 per cent of investigators reported excellent satisfaction on Zyclara® and placebo, respectively. i

The study data show the sequential therapy of cryotherapy and Zyclara® is safe and well tolerated. The most commonly reported adverse events were application site reactions, with application site pruritis, irritation and pain being the most frequent. i

Sequential therapy with Zyclara® improves clearance of cryosurgery-treated AKs, treats subclinical lesions, and enhances sustained complete clearance overall.

This study underlines the significant benefit of adding Zyclara® as a complement to the leading therapy choice - cryotherapy.

About Zyclara®

Zyclara® is an immune response modifier. This means it works by stimulating the body's own immune system to recognize and respond to treat AK lesions safely and effectively.

It is applied by the patient at home in a short course of therapy. It is used once daily, applied at bedtime to the skin of the affected area. Treatment duration is two weeks on, two weeks off, two weeks on, unless otherwise directed by a physician. In clinical trials, Zyclara® has demonstrated efficacy and safety in treating large areas of AK lesions and is generally well tolerated. The majority of local skin reactions were mild to moderate. The most common side effects included headache, application site pruritus (itching) and irritation, fatigue and nausea.

Zyclara® is available only by prescription.

Actinic Keratosis

AK is a sign of sun damage resulting from long-term exposure to harmful UV rays.3 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.4 These cellular mutations can then form AKs.vii

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.viii AKs can vary in shape and color, ranging from red to light or dark tan, pink, or a combination of these.viii These lesions may range from the size of a pinhead to larger than a quarter5 and may feel dry and rough like sandpaper.viii In the beginning, AKs can be so small that they are often identified by their rough texture rather than by sight.viii

Some AKs may develop into a serious form of skin cancer called squamous cell carcinoma, or SCC. AKs and SCCs share histologic and molecular features and can be considered incipient SCCs.6 Patients who present with multiple AKs have a higher risk of developing SCC and therefore treatment of AKs is recommended.

About Graceway Pharmaceuticals

Graceway Pharmaceuticals Canada ("Graceway Canada"), headquartered in London, ON, is a wholly-owned subsidiary of Graceway Pharmaceuticals, LLC, based in Bristol, TN in the United States. Graceway is a pharmaceutical company focused on acquiring, in-licensing, and developing branded prescription pharmaceutical products. Graceway initially acquired the imiquimod franchise as part of its acquisition of 3M's (NYSE: MMM) branded pharmaceutical business in the United States, and Canada. Graceway has also recently completed acquisitions of other molecules or compounds from, among other companies, Pfizer, Inc. (NYSE: PFE) and Gilead Sciences, Inc. (NASDAQ: GILD).

Current prescription products marketed by Graceway Canada include, among others, Aldara® (imiquimod 5%) Cream, Zyclara® (imiquimod 3.75%), QVARTM (beclomethasone dipropionate metered dose aerosol) and other products in women's health and cardiology. For more information on Graceway's products, including important safety information, please visit <http://www.gracewaypharma.ca/> www.gracewaypharma.ca<http://www.gracewaypharma.ca>

____________________________________________ iJorizzo J et al. "A Randomized Study of Treatment of Actinic Keratoses of the Full Face with Cryotherapy followed by Imiquimod 3.75% or Placebo Cream Applied Daily for Two 2-week Cycles." Poster presented at Summer AAD Annual Meeting 2010. Summary and Disussion.

ii Skin Cancer Foundation. "Actinic Keratosis and Other Precancers." Available at: http://www.skincancer.org/actinic-keratosis-and-other-precancers.html. Accessed on: September 2, 2009. Page 1, 3rd Paragraph.

iii Skin Cancer Foundation. "What Causes Actinic Keratosis" Available at: http://www.skincancer.org/what-causes-actinic-keratosis.html. Accessed 7/20/10. 1st Paragraph.

iv AcniticKeratosesNet. "What are Actinic Keratoses." Available at: www.skincarephysicians.com/ActinicKeratosesnet/whatare.html<http://www.skincarephysicians.com/ActinicKeratosesnet/whatare.html>. Accessed 7/10/10. 5th Paragraph.

v American Academy of Dermatology. "Actinic Keratoses." Available at: http://www.aad.org/public/publications/pamphlets/sun_actinic.html. Accessed 7/20/10. 2nd Paragraph

vi Clockerell CJ. Histopathology of incipient intraepidermal squamous cell carcinoma ("actinic keratosis"). J Am Acad Dermatol 2000; 42(1Pt2):11-17.

For further information:

Environics Communications: Daria Hopej (416) 969-2826 or Jaclyn Crawford (416) 969-2728 dhopej@environicspr.com

Posted: September 2010

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