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Company's Clinical Research Provider, BattelleCRO, to Shut Down. Completion of Rolling BLA Now Expected in Early Fourth Quarter
CAMBRIDGE, MA, USA | June 23, 2008 | Dyax Corp. (NASDAQ: DYAX) announced today 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.
Mr. Blair added: DX-88's clinical program is the largest placebo-controlled clinical program for any therapy studied for the treatment of HAE. We believe that DX-88's unique attributes, including its significant clinical experience in HAE patients, will position it well in the commercial setting over the long-term. The Company appreciates the dedication of all the investigators and patients who contributed to Dyax's HAE program.
About Dyax
Dyax is focused on advancing novel biotherapeutics for unmet medical needs, with an emphasis on oncology and inflammatory indications. Dyax utilizes its proprietary drug discovery technology to identify antibody, small protein and peptide compounds for clinical development. Dyax's lead product candidate is DX-88, a recombinant small protein that is currently in clinical trials for its therapeutic potential in two separate indications. Dyax has completed three Phase 2 trials and two Phase 3 trials of DX-88 for the treatment of hereditary angioedema (HAE). The second Phase 3 trial, known as EDEMA4, was conducted under a Special Protocol Assessment (SPA). DX-88 has orphan drug designation in the U.S. and E.U., as well as Fast Track designation in the U.S., for the treatment of acute attacks of HAE. Additionally, Dyax has completed a Phase 1/2 trial of DX-88 for the prevention of blood loss during on-pump coronary artery bypass graft (CABG) procedures. In April 2008, Dyax licensed to Cubist Pharmaceuticals the intravenous formulation of DX-88 for surgical indications in North America and Europe. Cubist is responsible for its ongoing development in this indication. Dyax identified DX-88 and other compounds in its pipeline using its patented phage display technology, which rapidly selects compounds that bind with high affinity and specificity to therapeutic targets. Dyax leverages this technology broadly with over 70 revenue generating licenses and collaborations for therapeutic discovery, as well as in non-core areas such as affinity separations, diagnostic imaging, and research reagents.
Dyax is headquartered in Cambridge, Massachusetts. For online information about Dyax Corp., please visit www.dyax.com.
SOURCE: Dyax Corp. |
