SALT LAKE CITY, July 25 /PRNewswire/ -- ZARS, Inc., announced today that it commenced the first of two Phase 3 clinical trials of ThermoProfen(TM) in patients with mild to moderate osteoarthritis (OA) of the knee on June 26, 2007.
The Company plans to conduct two, 12-week, three arm, double blind Phase 3 efficacy trials within the United States in patients with mild to moderate OA of the knee. These trials will be conducted with ThermoProfen, a matrix transdermal ketoprofen patch with an integrated CHADD(TM) (Controlled Heat-Assisted Drug Delivery) unit. In each of the two Phase 3 trials, 1500 patients will be randomized to one of three treatment groups to receive: ThermoProfen, a ketoprofen control (a patch with drug but no heat), or a heat control (a patch with heat but no drug). The primary measure of efficacy will be the patient's report of average pain intensity over the last 24 hours at Week 12. A predefined interim analysis will be conducted after approximately 100 patients in each group have completed the first study to determine if the projected number of 500 patients in each of the three groups will be sufficient to demonstrate a statistically significant difference in the primary efficacy endpoint. ThermoProfen is expected to provide localized pain relief with lower systemic levels than oral administration of ketoprofen, and is expected to reduce the frequency of adverse effects of oral ketoprofen and other oral NSAIDs.
"We believe that ThermoProfen could address the significant medical need of patients suffering from OA while at the same time lowering the risk of the negative side effects associated with chronic NSAID use," said Robert Lippert, President and Chief Executive Officer, ZARS. "These trials, assuming that they are successful, are intended to provide the pivotal data to support global marketing applications for ThermoProfen."
In addition to the two efficacy trials, an open-label safety trial will be conducted. In the safety trial, patients who complete either of the two efficacy trials will be able to use one or two ThermoProfen patches daily for up to one year. The Company also plans to initiate a two-year preclinical dermal carcinogenicity study.
OA is a disease of the joints that causes erosion of cartilage and leads to friction between bones. Based on data from IMS Health, we estimate that 6.5 million people in the United States have mild to moderate pain associated with OA of the knee. We believe that the number of individuals with OA of the knee will increase due to the growing U.S. population, shifting age demographics and additional factors including obesity that can increase the prevalence of OA. The two most common treatments for the pain associated with OA of the knee are non-selective and COX-2 selective NSAIDs.
About ZARS, Inc.
ZARS, Inc. is a specialty pharmaceutical company focused on the development and commercialization of topically applied drugs using its proprietary drug delivery technologies, primarily in the area of pain management. ZARS has developed a portfolio of proprietary products and product candidates based on its Controlled Heat-Assisted Drug Delivery (CHADD) and its phase-changing cream (Peel and DuraPeel(TM)) technologies. The Company's products and product candidates include two products that have been approved for marketing (Pliaglis(TM) and Synera(TM)), one product candidate for which it has initiated the first of two Phase 3 clinical trials (ThermoProfen) and two product candidates which are in Phase 1 clinical trials.
ZARS Safe Harbor Statement
This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The forward-looking statements are based on ZARS' current intent, belief and expectations. These statements are not guarantees of future performance and are subject to certain risks and uncertainties that are difficult to predict. Actual results may differ materially from these forward-looking statements and the Company cautions investors not to place undue reliance on the forward-looking statements contained in this release. Among other things, the Company's unproven business model, its dependence on new technologies, the uncertainties associated with and timing of clinical trials, the Company's ability to develop, commercialize and, in some cases, manufacture its products, its dependence on collaborators for services and revenue, its substantial indebtedness and lease obligations, changing requirements and costs associated with planned facilities, intense competition, uncertainties associated with the Company's ability to protect its patents and intellectual property, the Company's dependence on key management and key suppliers, uncertainties associated with governmental regulation of the Company's products, the impact of future alliances or transactions and other risks described in the Company's filings with the Securities and Exchange Commission. The Company is at an early stage of development and may not ever have products that generate revenues from commercial sales. ZARS undertakes no obligation to update or revise the information contained in this announcement whether as a result of new information, future events or circumstances or otherwise. The Company also disclaims any duty to comment upon or correct information that may be contained in reports published by the investment community.