Inflazyme Pharmaceuticals Proceeds with Clinical Phase IIb Asthma Study with IPL512,602
December 20, 2005
VANCOUVER, B.C., CANADA – Inflazyme Pharmaceuticals Ltd. (TSX: IZP) announced today it is proceeding with its Phase IIb clinical study in Q1 2006 with IPL512,602, an oral, once a day, anti-inflammatory medication for the control of asthma.
The Phase IIb study is an international study being undertaken in the US, Russia and several Central European countries. Dr. Kevin Mullane, Inflazyme’s President and CEO, stated “We are pleased to be taking IPL512,602 into a Phase IIb clinical study in persistent asthma in Q1 2006. We have selected a CRO capable of executing on this key study.” IPL512,602 showed statistical significance in an earlier Phase IIa clinical study in patients with mild asthma on clinical endpoints that are recognized markers of asthma control including quality of life measures and decreased need for rescue medication. These efficacy endpoints are incorporated into the Phase IIb study design, and are based on feedback received from the FDA.
The purpose of the Phase IIb study is to further evaluate the potential of IPL512,602 and its effect on asthma control in a moderate to severe asthmatic population. The Phase IIb clinical trial is a double blind, placebo controlled, parallel group study in moderate to severe asthmatics who are taking inhaled steroids but still suffering from significant symptoms which impact their lives, and requiring short acting bronchodilators to alleviate their asthma. IPL512,602 will be added on to their treatment to determine if it improves asthma control.
With this study and Helicon’s Phase IIa study in memory disorders with our compound, IPL455,903, Inflazyme will have two Phase II compounds in early 2006 with the potential to be ready to start a Phase III asthma study, in conjunction with a partner, in the second half of 2007. The Company expects results from Helicon’s Phase IIa study in the second half of 2006 and results from the asthma Phase IIb study in the first quarter of 2007.
Inflazyme recently completed a corporate restructuring which realized approximately C$7 million and now has approximately C$15 million in cash with which to fund the Phase IIb asthma study. The Company expects the cost of the Phase IIb study to be in the range of C$6 million.
Inflazyme will continue to seek to strengthen its financial position through divestiture of its non–core assets, a partnership for the asthma program as well as investigating other sources of financing. The Company believes its current financial position is sufficient to fund its operating requirements, including this Phase IIb study, into the second quarter of 2007.
Market Opportunity
The number of patients suffering from asthma continues to grow. In North America alone, based on estimates provided by the Centers for Disease Control, 21 million adults and 9 million children were diagnosed with asthma in 2003. According to the Global Initiative for Asthma, the number of people worldwide suffering from asthma is expected to grow from 300 million in 2004 to 400 million by 2025. The global market for asthma therapeutics was approximately US$10 billion in 2003 and this is expected to reach at least US$20 billion by 2010.
Conference Call
Inflazyme will host a conference call to discuss this announcement on Wednesday, December 21, 2005 at 1:00 p.m. Pacific Time/4:00 p.m. Eastern Time. To access the call, please dial 416-695-5259 or 1-877-667-7774. Audio replay of the conference call will be available until January 21, 2006 by calling 416-695-5275 or 1-888-509-0081.
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 www.inflazyme.com.
Statements in this news release other than historical information are forward-looking statements subject to risks and uncertainties. Actual results could differ materially depending on factors such as the availability of resources, the timing and effects of regulatory actions, the strength of competition, the outcome of litigation and the effectiveness of patent protection. Additional information regarding risks and uncertainties is set forth in the current Annual Information Form for Inflazyme on file with the Canadian Securities Commissions. The Toronto Stock Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of this information.
Contact:
Inflazyme Pharmaceuticals Ltd.
Julie Rezler, Sr. Director, Corporate Development
Tel: 1.800.315.3660/604.279.8511
Fax: 604.279.8711
E-mail: ir@inflazyme.com
Website: www.inflazyme.com
