Positive Topline Results from Phase II Trial (EDEMA2) with DX-88 for the Treatment of Hereditary Angioedema Presented at AAAAI Meeting.CAMBRIDGE, Mass. -- Dyax Corp. (Nasdaq:DYAX) today announced the presentation of positive topline data from the Company's completed open-label Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II , referred to 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. 2, with DX-88 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 this study DX-88 was well tolerated and successful in treating all types of attacks, including peripheral, abdominal and life-threatening laryngeal laryngeal /lar·yn·ge·al/ (lah-rin´je-al) pertaining to the larynx. la·ryn·geal or la·ryn·gal adj. Of, relating to, affecting, or near the larynx. attacks, whether administered through the intravenous (IV) or subcutaneous (SQ) route of administration. DX-88 is being developed in a joint venture with Genzyme Corporation for the treatment of HAE, a debilitating de·bil·i·tat·ing adj. Causing a loss of strength or energy. Debilitating Weakening, or reducing the strength of. Mentioned in: Stress Reduction and life-threatening inflammatory condition characterized by unpredictable attacks of severe pain and swelling. Dr. William Lumry, M.D., medical director and principal investigator Noun 1. principal investigator - the scientist in charge of an experiment or research project PI scientist - a person with advanced knowledge of one or more sciences of AARA AARA Allied Auto Racing Association AARA American Amateur Racquetball Association AARA Air To Air Refueling Area AARA After Action Reconstruction and Analysis AARA Actions Against Rammstein Accusations AARA Access & Amendment Refusal Authority Research Center of Dallas, TX, presented topline data from Dyax's open-label, EDEMA2 (Evaluation of DX-88's Effects on Mitigating Angioedema) trial in an oral presentation titled, "A Multicenter, Open-Label, Study of DX-88 for Multiple Attacks of Hereditary Angioedema; EDEMA2 Interim Results" at the American Academy The American Academy in Berlin is a non-partisan academic institution in Berlin. It was founded in September 1994 by a group of prominent Americans and Germans, among them Richard Holbrooke, Henry Kissinger, Richard von Weizsäcker, Fritz Stern and Otto Graf Lambsdorff and opened in of Asthma, Allergy & Immunology Conference (AAAAI AAAAI American Academy of Allergy Asthma and Immunology ) in Miami Beach Miami Beach, city (1990 pop. 92,639), Dade co., SE Fla., on an island between Biscayne Bay and the Atlantic Ocean; inc. 1915. It is connected to Miami by four causeways. , FL on Sunday, March 5, 2006. The topline results indicate that, in this study, DX-88 provided substantial therapeutic benefit in HAE patients who experienced acute attacks, including life-threatening laryngeal attacks. Dr. Lumry presented results on a subset of the 240 attacks that were treated in the trial. He presented data on 215 attacks observed in 72 patients who had variable or fixed doses of DX-88, either 5 mg/m2, 10 mg/m2 or 20 mg/m2 intravenously or 30 mg subcutaneously. Of the 215 attacks analyzed in the presentation, 176 attacks were treated in 62 patients through IV infusion and 39 attacks were treated in 22 patients through SQ administration, with 42 patients receiving multiple doses. Of the patients treated for multiple attacks, one was dosed 10 times, another 12 and a third 18 times. In this study, all types of attacks were treated by either IV or SQ administration of DX-88: laryngeal (n=31, 14.4%), abdominal (n=101, 47.0%), and peripheral (n=83, 38.6%). Clinical response, defined as beginning of improvement of HAE symptoms within four hours of dosing with DX-88, was observed at all dose levels. For the IV dosing (5 mg/m2, 10 mg/m2, 20 mg/m2), the response rates ranged from 86% to 100%, while the SQ outcome (30 mg fixed dose) showed a 100% response rate. The overall median time to onset of improvement for the 215 attacks was 28 minutes. The time to onset of response was slightly better (20 minutes) with SQ compared to IV administration. In a preliminary analysis, data to date indicate that time to significant improvement as well as maintenance of response at 24 hours appear to be dose and route dependent with the 30 mg SQ dose being superior to the IV administration at any dose. With regard to the overall safety profile of DX-88 in EDEMA2, the drug has been well tolerated. There have been no local injection site reactions. In the overall DX-88 experience to date, eight patients (4%) have experienced an acute dosing reaction: six patients on first administration (two patients in EDEMA2) of the IV infusion (probably related to infusion rate) and two patients (both in EDEMA2) after multiple administration (one IV and one SQ). These symptoms included rhinitis Rhinitis Definition Rhinitis is inflammation of the mucous lining of the nose. Description Rhinitis is a nonspecific term that covers infections, allergies, and other disorders whose common feature is the location of their symptoms. , flushing and nausea, but with no evidence of anaphylaxis anaphylaxis (ăn'əfəlăk`sĭs), hypersensitive state that may develop after introduction of a foreign protein or other antigen into the body tissues. , such as tryptase elevation. All patients responded rapidly to the treatment and had complete resolution of the HAE symptoms, showing no decrease in efficacy of the drug upon repeat dosing. DX-88 antibodies have been detected in three patients treated in this study. One patient had DX-88 antibodies with no apparent impact. Two patients with antibodies did manifest single, separate acute dosing reactions. Both patients have since been rechallenged, with one patient being retreated three times subsequent to rechallenge. There has been no recurrence of these side effects Side effects Effects of a proposed project on other parts of the firm. in either patient or decrease in efficacy in the patient retreated for HAE symptoms. Commenting on the program, Dr. Lumry stated, "I'm very impressed with the DX-88 results to date. Since there is no current treatment in the U.S. for acute HAE attacks, I believe that, if approved, DX-88 has great potential in the U.S. market." He added, "HAE patients live in constant fear of having an attack, and Dyax and Genzyme are tackling this issue head on in their trials. I continue to be encouraged by the high response rates to date and believe that DX-88 represents a real possible breakthrough in the treatment of hereditary angioedema." Dr. Thomas R. Beck, President and Chief Operating Officer Chief Operating Officer (COO) The officer of a firm responsible for day-to-day management, usually the president or an executive vice-president. of Dyax Corp., stated, "We are extremely pleased with the topline results from our EDEMA2 trial. In this open-label trial open-label trial Clinical research A trial in which doctors and participants know which therapy is being administered. See Blinding. , we were able to move to a fixed dose of 30 mg, the same dose currently being administered subcutaneously in our ongoing 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. By January 2006, we had administered 327 doses of DX-88 to 113 angioedema patients. With the breadth and depth of data from our program to date, we think that it is clear that we are on the right track to be first to market with a treatment for the U.S. HAE population." About Dyax Dyax Corp. is focused on advancing novel biotherapeutics for unmet medical needs, with an emphasis on cancer 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 of DX-88 for the treatment of hereditary angioedema (HAE). A pivotal Phase III trial is ongoing. Independently, Dyax has successfully completed a Phase I/II trial of DX-88 for the prevention of blood loss during heart surgery (CABG CABG coronary artery bypass graft. CABG abbr. coronary artery bypass graft CABG Coronary artery bypass graft, see there procedures) and is in partnering discussions for further development of DX-88 in this indication as well as planning a Phase IIb trial. 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 HAE. Dyax identified DX-88 and other compounds in its pipeline using Dyax's 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 its technology broadly with over 75 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 Disclaimer This press release contains forward-looking statements, including statements regarding the potential administration, dosing, safety and therapeutic benefit of DX-88 for HAE, its position versus other products in development for HAE and plans for development of DX-88 for CABG. 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 potential administration, dosing and therapeutic benefit of DX-88 for HAE, and its position versus other products in development for HAE 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 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. EDEMA2 is a service mark of Dyax Corp. Dyax is headquartered in Cambridge, Massachusetts, 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. |
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