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 www.inflazyme.com.

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.

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


'"/>




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:
*Name:
*Comment:
*Email:
(Date:10/4/2017)... Oct. 4, 2017 OBP Medical ... illuminating medical devices, today announced regulatory approval from ... Agency (or Agência Nacional de Vigilância Sanitária (ANVISA)) ... cordless surgical retractor with integrated LED light source ... illumination and exposure of a tissue pocket or ...
(Date:10/2/2017)... Halo Labs announces the European launch of their new low volume, ... 2017 in Cambridge, U.K on October 4th. ... samples with unprecedented speed and sensitivity while using far less sample ... ... system ...
(Date:9/27/2017)... , Sept. 27, 2017  Commended for their devotion to ... awards. Ranked as number one in the South Florida Business ... in Inc. 5000 yearly list, the national specialty pharmacy has ... Armando Bardisa will soon be honored by SFBJ as ... Set to receive his award in October, ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... The American Board of ... its next President and Chief Executive Officer, succeeding Dr. James C. Puffer upon his ... July 1, 2018 until Dr. Puffer’s retirement at the end of 2018. Upon assuming ...
(Date:10/13/2017)... ... October 13, 2017 , ... PurhealthRX , a leading Health and Nutrition ... the Purzorb™process to full spectrum CBD oil will revolutionize the rapidly growing CBD market ... can be easily incorporated into liquid products, while reducing costs to end users. , ...
(Date:10/13/2017)... ... , ... Lori R. Somekh, founder of the Law Office of Somekh ... law and special needs planning attorneys. “Membership in ElderCounsel helps our office remain up ... network with elder law attorneys nationwide,” said Somekh. , ElderCounsel was ...
(Date:10/13/2017)... ... October 13, 2017 , ... Many families have long-term insurance that ... insurance companies have a waiver for care if the client has a cognitive impairment ... family pays for care, is often waived, so the benefits from their insurance start ...
(Date:10/13/2017)... ... , ... Ellevate Network, the leading network for professional women, brought together some ... at their inaugural Summit in New York City in June. The event was livestreamed ... over 3 million. To watch the Mobilize Women video, click here . ...
Breaking Medicine News(10 mins):