Dyax Announces Final Patient Treated in Second Phase 3 Clinical Trial (EDEMA4) of DX-88 in Hereditary Angioedema
Company's Clinical Research Provider, BattelleCRO, to Shut Down
Dyax Corp. announced that it has treated the final patient in its second Phase 3, 96-patient trial of DX-88, known as EDEMA4, for the treatment of acute attacks of hereditary angioedema (HAE). HAE is a rare and life-threatening inflammatory condition for which there is no approved therapy in the United States.
The Company also announced today that it was recently notified by its clinical research provider, BattelleCRO, Inc., that Battelle Memorial Institute has decided to shut down BattelleCRO by June 30, 2008. As a consequence, Dyax is required to transfer BattelleCRO's clinical database to another clinical research service, a process which is underway with a global clinical research organization. After completion of the transfer, the newly housed database can be verified, locked and analyzed, and then prepared for filing as part of Dyax's rolling BLA.
This process is expected to move the completion date of the Company's rolling Biologics License Application (BLA) to the U.S. Food and Drug Administration for approval of DX-88 in HAE to the early fourth quarter of 2008. The Company will disclose topline data from the EDEMA4 study prior to completion of the BLA, once the data become available.
"Treatment of the last patient in our EDEMA4 study is another important step in advancing DX-88 for HAE. While we are disappointed by the untimely closure of BatelleCRO, we have taken immediate action to transfer our clinical database and finalize the BLA sequence," commented Henry E. Blair, Chairman, President and Chief Executive Officer. "We expect these final steps to be completed in a timely manner, while making certain that the BLA meets the highest regulatory standards."
Other news from the department research and development
Get the life science industry in your inbox
From now on, don't miss a thing: Our newsletter for biotechnology, pharma and life sciences brings you up to date every Tuesday and Thursday. The latest industry news, product highlights and innovations - compact and easy to understand in your inbox. Researched by us so you don't have to.
