Scientific Data Relating To Cinryze(TM) (C1 Esterase Inhibitor [Human]) Presented At International Congress Of The ... (Medical News Today) |
| Posted: 20 Mar 2010 04:30 AM PDT  Main Category: Allergy Also Included In: Clinical Trials / Drug Trials; Conferences; Pharma Industry / Biotech Industry Article Date: 20 Mar 2010 - 1:00 PDT ViroPharma Incorporated (Nasdaq: VPHM) announced the presentation of two abstracts relating to Cinryze™ (C1 esterase inhibitor [human]) therapy at the First International Congress of the Southern European Allergy Society in Florence, Italy. Cinryze was approved by the U.S. Food and Drug Administration in October 2008 for routine prophylaxis against hereditary angioedema (HAE) attacks in adults and adolescents. Cinryze is not approved in the European Union or any of its member states. "We are honored to be presenting HAE data at this important meeting," commented Peter Wijngaard, senior director, clinical development and European medical affairs, ViroPharma Europe. "ViroPharma is committed to raising awareness of HAE and educating healthcare professionals that may not have had any experience diagnosing and treating this rare disease." The following abstracts from studies supported by Lev Pharmaceuticals, now ViroPharma Biologics, Inc., a fully-owned subsidiary of ViroPharma, were presented: Poster Session 22: Phase 3 Results of Cinryze as Prophylactic and Acute Treatment of HAE -- In an abstract entitled, 'Safety and Efficacy of Nanofiltered C1 Inhibitor Concentrate for Acute and Prophylactic Treatment of Hereditary Angioedema due to C1 Inhibitor Deficiency,' Dr. Joshua Jacobs described two double-blind randomized placebo-controlled multi-center studies to determine the efficacy and safety of nanofiltered C1 inhibitor (C1-INH; Cinryze); -- One trial evaluated prophylactic treatment with C1-INH to prevent attacks. The second trial examined the use of C1-INH for the treatment of acute attacks of hereditary angioedema due to C1 inhibitor deficiency; -- Cinryze is not approved for acute attacks of HAE. Poster Session 23: Prophylactic Therapy Considerations in Hereditary Angioedema -- In an abstract entitled, 'When Should Prophylactic Therapy be Considered for Hereditary Angioedema?', Dr. Richard Gower described how a literature review, guideline analysis from other countries, an expert panel meeting, and consensus development were conducted in order to develop therapy considerations for prophylaxis of HAE in the U.S.; -- The abstract suggested that patients with frequent HAE attacks, severe attacks, past laryngeal attacks, excessive loss of work or school, significant anxiety and poor quality of life could be considered for prophylaxis therapy, especially for those that fail, are intolerant, have adverse events or are not candidates for androgens; -- This abstract was the result of a consensus group on the treatment considerations for patients with HAE, which was paid for and organized by Lev Pharmaceuticals. About Cinryze™ (C1 esterase inhibitor [human]) Cinryze is a highly purified, pasteurized and nanofiltered plasma-derived C1 esterase inhibitor product that has been approved by FDA for routine prophylaxis against angioedema attacks in adolescent and adult patients with HAE. C1 inhibitor therapy has been used acutely for more than 35 years in Europe to treat patients with C1 inhibitor deficiency. The most common adverse reactions observed have been upper respiratory infection, sinusitis, rash and headache. No drug-related serious adverse events (SAEs) have been observed in clinical trials. Severe hypersensitivity reactions may occur. Thrombotic events have occurred in patients receiving high dose off-label C1 inhibitor therapy well above the approved treatment dosage regimen. With any blood or plasma derived product, there may be a risk of transmission of infectious agents, e.g. viruses and, theoretically, the CJD agent. The risk has been reduced by screening patients for prior exposure to certain virus infections and by manufacturing steps to reduce the risk of viral transmission including pasteurization and nanofiltration. Cinryze is for intravenous use only. A dose of 1000 Units of Cinryze can be administered every 3 or 4 days for routine prophylaxis against angioedema attacks in HAE patients. Cinryze is administered at an injection rate of 1 mL per minute. About Hereditary Angioedema (HAE) HAE is a rare, severely debilitating, life-threatening genetic disorder caused by a deficiency of C1 inhibitor, a human plasma protein. This condition is the result of a defect in the gene controlling the synthesis of C1 inhibitor. C1 inhibitor maintains the natural regulation of the contact, complement, and fibrinolytic systems, that when left unregulated, can initiate or perpetuate an attack by consuming the already low levels of endogenous C1 inhibitor in HAE patients. Patients with C1 inhibitor deficiency experience recurrent, unpredictable, debilitating, and potentially life threatening attacks of inflammation affecting the larynx, abdomen, face, extremities and urogenital tract. Patients with HAE experience approximately 20 to 100 days of incapacitation per year. There are estimated to be at least 6,000 people with HAE in the United States. About ViroPharma Incorporated ViroPharma Incorporated is an international biopharmaceutical company committed to developing and commercializing innovative products for physician specialists to enable the support of patients with serious diseases for which there is an unmet medical need, and providing rewarding careers to employees. ViroPharma commercializes Cinryze(TM) (C1 esterase inhibitor [human]) for routine prophylaxis against angioedema attacks in adolescent and adult patients with hereditary angioedema (HAE). ViroPharma commercializes Vancocin(R), approved for oral administration for treatment of antibiotic-associated pseudomembranous colitis caused by Clostridium difficile and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains. ViroPharma currently focuses its drug development activities in diseases including C1 esterase inhibitor deficiency and C. difficile. Source: ViroPharma Incorporated
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