MediQuest Announces Positive Results from Phase III Study
Trial Holds Promise for Millions Suffering from Raynaud's Disease
BOTHELL, WA - Nov. 8, 2007 - MediQuest Therapeutics today announced that patients enrolled in a confirmatory Phase III study of MQX-503 - a topical formulation designed to treat Raynaud's Disease - showed significant improvements in their condition when treated with MQX-503. Raynaud's patients, 90 percent of whom are women, can experience severe pain associated with chronic vasospasm episodes in their hands, feet and other extremities.
MQX-503 is a locally acting, topical formulation that can be applied to prevent or treat Raynaud's episodes, giving patients control over their disease.
"With no FDA-approved therapy available for patients suffering from the symptoms of Raynaud's Disease," said Dr. Jeff Gregory, MediQuest chief medical officer, "these promising trial results bring hope to the more than 2 million people who suffer from moderate to severe Raynaud's in the United States."
The in-life clinical study was a multi-center, randomized, crossover, placebo-controlled trial of 109 patients with primary and secondary Raynaud's Disease.
"Results from this study reinforce previous clinical results and show that patients see improvements in their condition when taking MQX-503," said Dr. Gregory. "Equally important, the therapy is well-tolerated with minimal side effects."
The study concluded:
* MQX-503 successfully reduced the severity of Raynaud's Disease in the majority of patients in the confirmatory Phase III study. * MQX-503, as compared to placebo, is well-tolerated by patients with primary and secondary Raynaud's Disease. * More patients experienced a clinically significant improvement in their Raynaud's while on MQX-503 than while on placebo. * Patients consider the symptoms experienced during Raynaud's attacks more important than the number and duration of attacks when determining the impact of Raynaud's disease on their lives.
"With the conclusion of this clinical study, MediQuest is one step closer to submitting the MQX-503 New Drug Application to the FDA," said Dr. Frederick Dechow, MediQuest president and CEO. "Our proprietary drug delivery technology provides a unique platform to deliver active therapeutic agents to specific problem areas. MQX-503 is a new therapy specifically designed to treat this unmet clinical need."
Highlights from this study will be formally presented at the annual American College of Rheumatology (ACR) meeting in Boston, Nov. 7 - 11. Copies of the abstract can be found online at www.rheumatology.org/annual.
In addition to MQX-503, MediQuest's robust pipeline includes two drug candidates in clinical trials, one at the pre-clinical stage and others at the research stage. The company develops first- and best-in-class topical therapies to treat patients suffering from inflammatory and infectious diseases.
About Raynaud's Disease:
Raynaud's patients can experience severe pain associated with chronic vasospasm episodes in their hands, feet and other extremities. Essentially, two options exist for the 2.1 million patients seeking medical treatment. Patients can either take systemic medications designed to treat other conditions or modify their behavior in an attempt to subdue symptoms. MediQuest's therapy will potentially deliver relief through a topical formulation applied locally to prevent or treat Raynaud's episodes.
About MediQuest Therapeutics, Inc.
MediQuest Therapeutics is a specialty pharmaceutical company using its proprietary topical delivery system in late-stage clinical trials targeting infectious and inflammatory skin diseases and conditions. The Company's major efforts are focused on projects targeting Raynaud's phenomenon, nail psoriasis and actinic keratosis.
In addition to historical facts or statements of current condition, this press release contains forward-looking statements within the meaning of the 'Safe Harbor' provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements provide the Company's current expectation or forecasts of future events. MediQuest's performance and financial results could differ materially from those reflected in these forward-looking statements due to the decisions of regulatory authorities, ability to implement its commercial plans, general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries generally. For a discussion of these and other risks and uncertainties that may affect the forward-looking statements please contact the Company. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. MediQuest undertakes no obligation to update publicly any forward-looking statement.