June 24, 2006
deCODE genetics (Nasdaq:DCGN) today announced positive results from its preliminary Phase II clinical trial (Phase IIa) of Cephalon Inc.’s (Nasdaq: CEPH) CEP-1347 in asthma. Data on patients receiving active drug in the trial were consistent with a dose-dependent improvement in some parameters of lung function examined in the study, including methacholine challenge test and peak expiratory flow rates, as well as in a biomarker associated with asthma severity and inflammation. There was no evidence of safety and tolerability concerns.
The study was randomized, double-blind, placebo-controlled, and enrolled 160 patients divided evenly into four groups, three receiving various doses of active drug and one receiving placebo. The trial, conducted by deCODE under a research collaboration and licensing agreement with Cephalon, was based upon deCODE’s discovery of variants in the gene encoding the MAP3K9 kinase as risk factors for the development of asthma. The MAP3K9 kinase acts within a pathway targeted by CEP-1347.
“Through our genetics work we have put our finger on an important biological pathway involved in asthma; the results of this trial indicate that CEP-1347 can positively affect this pathway in a safe and well-tolerated manner,” said Kari Stefansson, CEO of deCODE. “This is an exciting opportunity to bring forward a novel, non-steroidal treatment for one of the most common chronic conditions in the industrialized world. This is also a stellar example of the way in which we are using genetics to develop new methods to treat and prevent common diseases. We presented the data from the trial to Cephalon at the end of last week, and we look forward to discussing with them how to further examine the beneficial effects of CEP-1347 in asthma patients.”
Asthma is a chronic condition resulting from inflammation of the airway. It is the most common chronic disorder in children and young adults, ranging in prevalence from 10-30% in the industrialized world. Asthma attacks, which range from mild wheezing to severe constriction of breathing requiring immediate medical intervention, result from an abnormal and exaggerated immune response to certain environmental “triggers” – including pollen, dust, tobacco smoke and viral infection. The most effective treatment for asthma is the family of steroids known as glucocorticoids. These drugs are effective in controlling symptoms attributed to airway inflammation, but also have potentially serious side-effects, particularly when administered over a long period of time. One of the principal goals in the development of new methods for treating asthma is therefore to identify non-steroidal drugs that can effectively control the inflammatory response underlying asthma symptoms.
deCODE genetics (NASDAQ:DCGN) is a global leader in applying human genetics to develop drugs for common diseases. Our population approach has enabled us to discover and target key biological pathways involved in conditions ranging from heart attack to cancer. We are turning these discoveries into new medicine to better treat and prevent many of the biggest challenges to public health. deCODE is delivering on the promise of the new genetics.SM Visit us on the web at www.decode.com.
Any statements contained in this presentation that relate to future plans, events or performance are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, among others, those relating to technology and product development, integration of acquired businesses, market acceptance, government regulation and regulatory approval processes, intellectual property rights and litigation, dependence on collaborative relationships, ability to obtain financing, competitive products, industry trends and other risks identified in deCODE’s filings with the Securities and Exchange Commission. deCODE undertakes no obligation to update or alter these forward-looking statements as a result of new information, future events or otherwise.