Navigation Links
Inflazyme Announces Outcome of Review of Phase 2b Asthma Study:,Potential Mitigating Factors Identified which Prevent Clear,Interpretation of Results

RICHMOND, British Columbia, March 12, 2007--Inflazyme Pharmaceuticals Ltd. (TSX: IZP). As announced on January 29, 2007, the preliminary results of the Phase 2b CAPSICS study with IPL512,602 showed no statistical or clinical difference between patients who received drug or placebo. However, the placebo response was surprisingly large and consistent across a number of the end-points, which prompted an examination by Inflazyme and its external experts to determine if anything untoward had occurred during the study.

To put the placebo response in perspective, we compared the results of our study to publications of other asthma clinical studies where Asthma Quality of Life was used as an endpoint. Our placebo response was two to three times greater than generally observed. Dr. William Busse and Dr. Mark FitzGerald, two leading clinical asthma experts who reviewed the data, agreed that "the large magnitude of the placebo response is surprising and could potentially obscure any apparent benefits of IPL512,602".

Our medical advisors have offered three possible factors contributing to the high placebo response. First, as is not uncommon, the study did not include placebo treatment during the run-in period at the start of the trial when patients were to be stabilized on their existing therapy. Observing a large placebo effect during this run-in period could have excluded those patients from the study.

Second, subjects were on a background therapy of inhaled corticosteroids and it is not possible to determine if there may have been compliance issues whereby patients were not taking their medications on a consistent basis as prescribed in the run-up to the study. A part of the placebo response might indeed be attributable to patients, once enrolled into the study, paying more attention to their symptoms and becoming more compliant with their background medications.This may have resulted in an improvem ent in their asthma independent of treatment with IPL512,602.

Finally, a large proportion of the patients were recruited during the summer allergy season, and the patients’ allergies might have diminished during the treatment phase of the trial as the allergy season waned. Resolution of allergic rhinitis could improve asthma symptoms and other measures of asthma control in all patients independent of treatment.

Our Phase 2b study was of a standard design generally used in this setting, such that these issues were not anticipated. However, taken together, we believe these issues nullify interpretation of the Phase 2b study.

Inflazyme believes that IPL512,602 would benefit from additional clinical investigation to confirm its potential as an oral treatment for asthma. The Company has significant clinical data from the earlier Phase 2a study in mild to moderate asthmatics completed by Aventis pharma (now sanofi-aventis) in June 2004, and substantial preclinical evidence indicating that the drug has efficacy in asthma. Today, Inflazyme has insufficient cash resources to conduct additional clinical trials with this product. Inflazyme plans to share these findings with other parties in an attempt to realize commercial value for this program.

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 oth er 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.

Inflazyme Pharmaceuticals Ltd.
Julie Rezler, Sr. Director, Corporate Development
Tel: 1.800.315.3660/604.279.8511
Fax: 604.279.8711


Related medicine technology :

1. Antisoma Announces Further Data From ASA404 Ovarian Cancer Trial
2. Neose Announces Presentation of Positive Preclinical Data on GlycoPEGylated Factor VIIa at the XXI Congress of the International Society on Thrombosis and Haemostasis
3. Biofrontera AG Announces Clinical Study Confirms Excellent Efficacy of BF-200 ALA In Actinic Keratosis
4. YM BioSciences Announces Secondary Efficacy and Safety Findings in Randomized Phase IIB Aerolef Trial
5. BioSante Pharmaceuticals Announces New Findings for Potential Bird Flu Vaccine
6. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
7. Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for Oral Oleoyl-estrone
8. AVI BioPharma Partner Cook Medical Announces Completion of Patient Enrollment for APPRAISAL Phase II Clinical Trial for Treatment of Cardiovascular Disease
9. Protox Announces Positive Clinical Data from Prostate Cancer Study
10. Inspire Announces Webcast of Presentation at C.E. Unterberg, Towbin Emerging Growth Opportunities Conference
11. NexMed Announces Completion of Patient Enrollment in Two Pivotal Phase 3 Studies for Anti-Fungal Product
Post Your Comments:
(Date:10/13/2015)... 2015  Graduate students across the country, with ... will soon have the opportunity to learn about ... drug discovery and development process. Eli Lilly and ... 10 leaders from academic institutions to create an ... of Drug Development."  Lilly will formally unveil the ...
(Date:10/13/2015)... 13, 2015 anesthesia and respiratory ... billion by 2022, according to a new report by ... to their capability to resolve various environmental and lifestyle ... growth. --> anesthesia and respiratory devices market ... 2022, according to a new report by Grand View ...
(Date:10/13/2015)... 2015   Micell Technologies , Inc. today announced ... trials of its MiStent Sirolimus Eluting Absorbable Polymer Coronary ... presented at the 27th Annual Transcatheter Cardiovascular Therapeutics ( ... , October 11-15. TCT is the world,s largest ... was designed to optimize vessel healing in patients with ...
Breaking Medicine Technology:
(Date:10/13/2015)... Angeles, CA (PRWEB) , ... October 13, 2015 ... ... growing natural beverage companies in the United States, today announced the release of ... Brew Coffee, and new Cranberry Cocktail Agua Fresca. All feature the unique flavor ...
(Date:10/13/2015)... ... October 13, 2015 , ... ... ENGAGE, at HIMSS’s Patient Engagement Summit . HealthAware is a technology company ... health programs and interventions via mobile devices that provide a framework for the ...
(Date:10/13/2015)... CA (PRWEB) , ... October 13, 2015 , ... ProText ... Pro X . With ProText Kinetic Panel, users can create energetic text animations in ... a preset into the Final Cut Pro X timeline and stylize the text. With ...
(Date:10/13/2015)... (PRWEB) , ... October 13, 2015 , ... Symposium Chairman, ... the 19th annual Dallas Cosmetic Symposium to be held March 2nd and 3rd, 2016. ... immediately afterwards, draws plastic surgeons and cosmetic physicians from around the world. , Key ...
(Date:10/13/2015)... PA (PRWEB) , ... October 13, 2015 , ... In ... 2015 utility costs were 36 percent lower per square foot than in 2009. The ... actual cost of heating and cooling has decreased by eight percent. , According ...
Breaking Medicine News(10 mins):