Inflazyme Pharmaceuticals Ltd.

Inflazyme Pharmaceuticals Ltd.

November 08, 2006 16:54 ET

Inflazyme Successfully Completes Patient Enrolment in Phase IIb Trial With IPL512,602 in Asthma

VANCOUVER, BRITISH COLUMBIA--(CCNMatthews - Nov. 8, 2006) - Inflazyme Pharmaceuticals Ltd. (TSX:IZP) today announced it had successfully completed patient enrolment in its Phase IIb trial with IPL512,602 for the treatment of moderate to severe asthma. This international study enrolled 218 subjects at centers in the US, Russia, Poland, Bulgaria and the Ukraine. The study began in May 2006 and it is on track to complete in Q1 2007 with top line results expected shortly thereafter.

The Phase IIb trial, also known as the Control of Asthma Patients Symptomatic on Inhaled Corticosteroids (CAPSICS) study, is an eight week, randomized, double blind, parallel group, multi-center trial. The purpose of the study is to evaluate the efficacy and safety of once daily, oral dosing of 20 mg of IPL512,602 against placebo. Enrolled in the study are those patients with moderate to severe asthma who still experience significant symptoms which are not well controlled despite taking prescribed medications. IPL512,602 represents a new therapeutic approach discovered by Inflazyme that focuses on improving asthma control and reducing asthma symptoms.

The purpose of this study is to evaluate the effects of IPL512,602 on several measures of asthma control including asthma quality of life assessed using the FDA endorsed Juniper questionnaire. Additional measures of asthma control include the incidence of night-time awakenings, need for rescue medication (in the form of short-acting beta-agonists), and asthma symptoms. "Completion of enrolment in the CAPSICS study represents an important milestone for Inflazyme in the development of IPL512,602 as a potential novel treatment for asthma," said Dr. Kevin Mullane, President and Chief Executive Officer of Inflazyme Pharmaceuticals.

He added, "Our earlier Phase IIa trial in patients with mild to moderate asthma showed clinically meaningful benefits on measures of asthma control including Asthma Quality of Life Questionnaire scores and the reduced need for rescue medication, as well as airway hyper-responsiveness, an important marker for airway inflammation. Moreover, the patients who were most affected by their asthma going into the study appeared to derive the most benefit. Consequently, the Phase IIb CAPSICS study is designed to build on these findings by evaluating patients whose lives are significantly impacted by their asthma."

About Asthma

Over 300 million people worldwide are affected by asthma and according to the Global Initiative for Asthma (GINA) this number is expected to increase to 400 million people by 2025. Based on the most current figures from the US Center for Disease Control, as many as 14 million adults and 6 million children in the US were diagnosed with asthma in 2002.

Poorly controlled asthma affects millions of asthma patients each year. According to a Patient and Physician Survey conducted in 2006 by the American College of Allergy, Asthma and Immunology, less than 50% of patients can manage or prevent their symptoms using current therapies. The American Lung Association now offers a questionnaire for patients and physicians to help in the diagnosis of poorly controlled asthma.

About Inflazyme

Inflazyme Pharmaceuticals is a biopharmaceutical company pioneering medical breakthroughs to transform the lives of patients with respiratory and inflammatory diseases worldwide. Further information on the Company may be obtained from its website at

This news release contains certain "forward-looking statements" and "forward-looking information" which may include but is not limited to statements in respect of our future financial position or operations. Words like "believe", "intend", "may", "expect", "anticipate", "plan", "should" and other similar expressions are forward-looking statements that involve a number of risks and uncertainties. By their nature, forward-looking statements involve numerous factors, assumptions and estimates, some but not all of the factors that could cause actual results to differ materially from those projected in our forward-looking statements include among others: risks associated with the completion of clinical trials and obtaining regulatory approval to market our products, market acceptance of our technologies and products; our ability to obtain financing; our financial and technical resources relative to those of our competitors; our ability to enforce our intellectual property rights and protect our proprietary technologies; the ability to obtain and develop partnership opportunities; and other risk factors identified from time to time in the Company's regulatory filings. For a further description of the principal risks affecting the Company, see our regulatory filings. These factors should be considered carefully and readers are cautioned not to place undue reliance on such forward-looking statements. The Company disclaims any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements.

Contact Information

  • Inflazyme Pharmaceuticals Ltd.
    Julie Rezler
    Sr. Director, Corporate Development
    (604) 279-8511 or 1-800-315-3660
    (604) 279-8711 (FAX)