Development of Dyax's Patient Reported Outcome for the Treatment of Hereditary Angioedema Presented at ACAAI Meeting
One of Dyax's key investigators for HAE, Martha White, M.D., Institute for Allergy & Asthma, Wheaton, MD, presented the poster entitled "Development of a Patient Reported Outcome (PRO) Measure to Assess Symptom Severity and Change in Hereditary Angioedema (HAE)." This poster covered the overall development of a comprehensive PRO methodology, which included two measurements: a Treatment Outcome Score (TOS) and a Mean Symptom Complex Severity (MSCS) score, which assess symptom occurrence in all possible body sites; severity of symptoms within each site; emerging symptom complexes during an attack; and improvement or decline within each symptom site. These PRO measurements were developed because no objective physical sign or quantitative test exists that can be used to define or characterize the severity of HAE attack-related symptoms. Dyax's clinical program for HAE incorporated the development and validation of these PROs.
A comprehensive validation protocol has been followed, which has demonstrated content and construct validity. As part of this, analyses conducted in a subset of patients in Dyax's EDEMA2 clinical trial confirmed that TOS and MSCS were highly correlated with the conceptually related measures of pain (McGill Pain VAS and Present Pain Intensity scale). All input from patients, clinicians/experts and regulatory agencies was used to refine the TOS and MSCS measures used in the EDEMA3 trial and that are also currently being used in the EDEMA4 trial.
Commenting on the poster, Dr. White stated, "I was happy to have the opportunity to present the development of the PRO measurements used in Dyax's HAE clinical trials. TOS and MSCS are the first composite measures of their kind to take into account the full range of symptoms and symptom severity that can be experienced during an HAE attack, and following the scores over time allows one to accurately assess changes in total symptom severity." She added, "As a treating physician for Dyax's HAE clinical program, I believe that these comprehensive endpoints are highly relevant when assessing the overall extent and severity of an acute attack."
"I would like to recognize Dr. White for her time and effort devoted to our HAE program," commented Henry Blair, Chairman, President and Chief Executive Officer of Dyax. "In collaboration with the regulatory authorities, key opinion leaders and patients, we developed these unique and comprehensive measurements for evaluating HAE attacks. We are pleased with the PRO results observed from EDEMA3 and look forward to its utilization in the ongoing EDEMA4 trial."
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 a Phase 3 trial of DX-88 for the treatment of hereditary angioedema (HAE). A second Phase 3 trial, known as EDEMA4, is currently being 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. A Phase 2 trial for further development of DX-88 in on-pump cardiothoracic surgery (CTS), including CABG and heart valve replacement or repair procedures, is ongoing.
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, and has antibody discovery facilities in Liege, Belgium. For online information about Dyax Corp., please visit www.dyax.com.
Dyax Disclaimer
This press release contains forward-looking statements, including statements regarding Dyax's patient reported outcome measures used for its HAE program, including the progress of ongoing clinical trials and the prospects for regulatory filings and approvals for DX-88. Statements that are not historical facts are based on Dyax's current expectations, beliefs, assumptions, estimates, forecasts and projections about the industry and markets in which Dyax competes. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors which may affect the prospects for regulatory filings for DX-88 include the risks that: DX-88 may not show therapeutic effect or an acceptable safety profile in clinical trials or could take a significantly longer time to gain regulatory approval than Dyax expects or may never gain approval; others may develop technologies or products superior to DX-88; Dyax is dependent on the expertise, effort, priorities and contractual obligations of third parties in the clinical trials, manufacture, marketing, sales and distribution of its biopharmaceuticals; DX-88 may not gain market acceptance; Dyax may not be able to obtain and maintain intellectual property protection for DX-88 for the duration of Dyax's patent covering DX-88; and other risk factors described or referred to in Dyax's most recent Annual Report on Form 10-K and other periodic reports filed with the Securities and Exchange Commission. Dyax cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Dyax undertakes no obligations to update or revise these statements, except as may be required by law.
Dyax, the Dyax logo, EDEMA2, EDEMA3 and EDEMA4 are registered trademarks of Dyax Corp.
Contact
Dyax Corp.
Ivana MagovÄ?eviÄ?-Liebisch, 617-250-5759
General Counsel and Executive Vice President
of Administration
imagovcevic@dyax.com
or
Nicole Jones, 617-250-5744
Associate Director, Investor Relations and
Corporate Communications
njones@dyax.com
Posted: November 2007
