Dyax Announces Final Patient Treated in Pivotal Phase III Clinical Trial (EDEMA3) for DX-88 in Hereditary Angioedema.- FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. Broadens Fast Track Designation for DX-88 in HAE - CAMBRIDGE, Mass. -- Dyax Corp. (Nasdaq:DYAX) announced today that it has completed the double-blind portion of its pivotal Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the , known as EDEMA edema (ĭdē`mə), abnormal accumulation of fluid in the body tissues or in the body cavities causing swelling or distention of the affected parts. 3, for its lead product candidate DX-88 (ecallantide) for the treatment of hereditary angioedema Hereditary angioedema A complement deficiency characterized by lymphatic vessel blockages that cause temporary swelling (edema) of areas of the skin, mucous membranes, and, sometimes, internal organs. Mentioned in: Complement Deficiencies (HAE). In addition, the U.S. Food and Drug Administration has also broadened the Fast Track designation for DX-88 for the treatment of all types of acute HAE attacks, a rare and life-threatening inflammatory condition for which there is no approved therapy in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. . The Fast Track program is designed to facilitate the development and expedite regulatory review of investigational drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. The 72-patient, placebo-controlled, multi-center EDEMA3 trial was conducted to determine the efficacy of the 30 mg subcutaneous subcutaneous /sub·cu·ta·ne·ous/ (sub?ku-ta´ne-us) beneath the skin. sub·cu·ta·ne·ous adj. Abbr. s.c., SQ Located, found, or placed just beneath the skin; hypodermic. (SC) dose of DX-88 for patients suffering from moderate to severe acute HAE attacks. The trial is comprised of two phases: a double-blind, placebo-controlled phase and a repeat dosing phase. In the first phase, which is now completed, HAE patients received either a single 30 mg SC dose of DX-88 or placebo. The second phase of the study, which continues to treat patients, allows for open-label SC DX-88 to be administered for acute attacks. The final results of the double-blind phase of the EDEMA3 trial will be made public after the data have been collected, verified, clinical database locked and analyzed. "The treatment of the final patient in this pivotal Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA trial and the broadening of the Fast Track designation mark a significant milestone for the DX-88 HAE program," said Henry E. Blair, Chairman and Chief Executive Officer of Dyax. "We have collected an extensive amount of clinical information to date with approximately 600 doses of DX-88 administered to approximately 250 individuals. Furthermore, DX-88 has continued to demonstrate a good safety profile and has been well tolerated on single and multiple dosing. The rapid completion of this trial, which was the largest placebo-controlled trial conducted for this indication, demonstrates that we have significant support from HAE patients and physicians. We, and our partner Genzyme, remain committed to delivering this treatment to the HAE patient community." 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. In its joint venture with Genzyme Corporation, Dyax has successfully completed three Phase II trials and a pivotal Phase III trial of DX-88 for the treatment of hereditary angioedema (HAE). A confirmatory study, known as EDEMA4, is planned and expected to begin in the first quarter of 2007. DX-88 has orphan drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the 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. Independently, Dyax has successfully completed a Phase I/II trial of DX-88 for the prevention of blood loss during on-pump CABG CABG coronary artery bypass graft. CABG abbr. coronary artery bypass graft CABG Coronary artery bypass graft, see there procedures. Dyax is currently planning a Phase IIb trial for further development of DX-88 in on-pump cardiothoracic surgery Cardiothoracic surgery is the field of medicine involved in the surgical treatment of diseases affecting organs inside the thorax (the chest). Generally treatment of conditions of the heart (heart disease) and lungs (lung disease). (CTS (1) (Clear To Send) The RS-232 signal sent from the receiving station to the transmitting station that indicates it is ready to accept data. Contrast with RTS. (2) (Common Type System) The data typing used in . ), including CABG and valve procedures. Dyax identified DX-88 and other compounds in its pipeline using its patented phage display phage display n. A technique using recombinant DNA technology to create bacteriophages with a desired peptide embedded in the surface of their protein shells. 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 This article is about the city of Cambridge in Massachusetts. For the English university town, see Cambridge, England. For other places, see Cambridge (disambiguation). Cambridge, Massachusetts is a city in the Greater Boston area of Massachusetts, United States. , and has antibody discovery facilities in Liege liege In European feudal society, an unconditional bond between a man and his overlord. Thus, if a tenant held estates from various overlords, his obligations to his liege lord, to whom he had paid “liege homage,” were greater than his obligations to the other , Belgium. For online information about Dyax Corp., please visit www.dyax.com. Dyax Disclaimer This press release contains forward-looking statements, including statements regarding clinical trials, the potential administration, dosing, safety and therapeutic benefit of DX-88 for HAE, and plans for development of DX-88 for CTS. 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 clinical trials, the potential administration, dosing and therapeutic benefit of DX-88 for HAE and plans for development of DX-88 for CTS, include the risks that: DX-88 may not show sufficient 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 or that are on the market before DX-88; DX-88 may not gain market acceptance; Dyax is dependent on the expertise, effort, priorities and contractual obligations of third parties in the clinical trials, manufacture, marketing, sales and distribution of DX-88; and other risk factors described or referred to Item 1A, "Risk Factors" in Dyax's most recent Annual Report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 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 and the Dyax logo are the registered trademarks of Dyax Corp. EDEMA3 and EDEMA4 are service marks of Dyax Corp. |
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