Monday July 26, 9:30 am Eastern Time
Company Press Release
SOURCE: Elan Corporation, plc
DUBLIN, Ireland, July 26 /PRNewswire/ -- Elan Corporation, plc (NYSE: ELN - news; "Elan") today announced preliminary results of a Phase II clinical study evaluating Antegren® (natalizumab), a humanized monoclonal antibody, in the treatment of acute exacerbation in patients with multiple sclerosis ("MS"). The results are consistent with results observed in an earlier multiple-dose Phase II study indicating the potential utility of Antegren for chronic treatment of patients with MS, but do not support continued effort in the acute therapeutic program.
The study measured existing and new gadolinium enhancing lesions by magnetic resonance imaging ("MRI") at baseline and then at Weeks 1, 3 and 14. To date, only MRI data through week three have been analyzed. There was a trend in favor of Antegren treatment for the proportion of patients with an improvement in existing gadolinium enhancing lesion counts. Similar results were also noted in the analysis of new gadolinium enhancing lesions. These preliminary data are consistent with the earlier multiple-dose study that showed a similar trend after four weeks of Antegren treatment. Both studies suggest that Antegren may have a beneficial effect in suppressing new lesion formation if administered chronically.
In this acute study, patients were treated with a single dose of Antegren within 96 hours of the onset of their MS exacerbation. The clinical effect of Antegren was measured by the Kurtzke Expanded Disability Status Scale (EDSS) at baseline, 72 hours and then at Weeks 1, 2, 3, 4, 6, 8 and 14. To date, only data from the first four weeks have been analyzed. The primary endpoint was a change in EDSS from baseline to week one and no statistically significant change was observed.
"Unlike the animal models where activity is shown within one week, data from the human clinical studies to date suggests that Antegren takes three to four weeks to reach therapeutic effect," said Donal Geaney, Chairman and CEO of Elan. "These results, along with the results from the multiple-dosing study, support the initiation of chronic studies to investigate the potential of Antegren to slow the progression of MS. We will now focus our development resources in this area and plan to initiate Phase II chronic studies this quarter. Antegren is also in Phase II studies for the treatment of inflammatory bowel disease."
The development of Antegren is being funded in part by Axogen Limited, a Bermuda corporation that develops therapeutic products for persons with neurological disorders. American Depositary Shares of Axogen trade on the American Stock Exchange and the outstanding common shares of Axogen are subject to a purchase option held by Elan, which expires on December 31, 2001.
Elan is a leading worldwide specialty pharmaceutical company headquartered in Ireland, with its principal research, development, manufacturing and marketing facilities located in Ireland, the United States and Israel. Elan shares trade on the New York, London and Dublin Stock Exchanges.
This press release contains forward-looking statements by Elan and actual results could differ materially from those described as a result of a variety of factors including but not limited to the following. There can be no assurance that Antegren will be successfully developed, that results of human clinical trials will be consistent with preclinical results, that any results will be supportive of regulatory approvals required to market products, or that regulatory approvals will be granted.
SOURCE: Elan Corporation, plc