Study generates promising data about sustained durability of Zyclara's efficacy versus cryosurgery alone

Graceway Pharmaceuticals, LLCAug 7 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.

“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.”

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."