Navigation Links
Study Shows C1-Esterase Inhibitor Concentrate is Safe and Consistently Effective for Long-Term Treatment of Hereditary Angioedema Attacks at Any Body Location
Date:11/5/2011

BOSTON, Nov. 5, 2011 /PRNewswire/ -- C1-esterase inhibitor (C1-INH) concentrate at 20 U/kg is a safe and effective therapy for the long-term treatment of successive acute swelling attacks at any body location in patients with hereditary angioedema (HAE), a rare and serious genetic disorder, according to final data presented at the 2011 American College of Allergy, Asthma & Immunology (ACAAI) Annual Meeting. Additional data presented at the meeting confirms that C1-INH concentrate provided consistent and reliable treatment response in patients treated for multiple successive HAE attacks at any body location.

The final results from the prospective, open label International Multi-center Prospective Angioedema C1-Inhibitor Trial (I.M.P.A.C.T. 2) with C1-INH concentrate showed a median time to the onset of symptom relief of 0.46 hours which was similar for all types of attacks, including laryngeal, abdominal, peripheral and facial. The median time for complete resolution was 15.5 hours.

"The final I.M.P.A.C.T. 2 results provide conclusive clinical evidence that C1-INH replacement therapy should be considered the first-line therapy in the on-demand treatment of acute swelling attacks of hereditary angioedema," said Timothy J. Craig, D.O., Professor of Medicine and Pediatrics at Penn State University in Hershey, PA.  "These compelling data reflect the outcomes of 1,085 HAE attacks, the largest number of HAE attacks treated in a prospective study, and show that C1-INH concentrate is highly and consistently effective, safe and well-tolerated in rapidly relieving symptoms of HAE at many different regions of the body, with no rebound effects. In fact, 99 percent of all attacks were successfully treated with a single dose of 20U/kg."

The effect of repeated treatment on the efficacy of C1-INH was also assessed in an analysis of 18 patients who were treated for at least 15 attacks. Results showed that the extent of previous use of C1-INH concentrate had no effect on the time between attacks treated with C1-INH concentrate, the time to onset of symptom relief or the time to complete resolution.

HAE is a genetic disorder caused by a deficiency of C1-INH and is inherited in an autosomal dominant manner. Symptoms of HAE include episodes of edema or swelling in the face, abdomen, larynx and extremities. Patients who have abdominal attacks of HAE can experience episodes of severe pain, diarrhea, nausea and vomiting caused by swelling of the intestinal wall. HAE attacks that involve the face can cause painful distortion and painful swelling.  Diagnosis of HAE requires a blood test to confirm low or abnormal levels of C1-INH.  

For further information about HAE, please visit the website of the International Patient Organization for C1-Inhibitor Deficiencies, www.HAEI.org and the disease information website www.allabouthae.com.

About I.M.P.A.C.T. 1

I.M.P.A.C.T. 1 was a study of 124 HAE patients with acute, moderate or severe abdominal or facial attacks. C1-INH concentrate was administered at two different doses and compared with placebo. The main study endpoints were time to onset of symptom relief from HAE attacks, proportion of subjects with worsening clinical HAE symptoms and safety.  

The I.M.P.A.C.T. 1 study found that C1-inhibitor concentrate (C1-INH) is effective and safe in rapidly treating acute abdominal and facial skin swellings in adults and adolescents with HAE.  The study found that the median time to symptom relief was 30 minutes after receiving C1-INH compared with 1.5 hours with a placebo.

About I.M.P.A.C.T. 2

Findings of I.M.P.A.C.T. 2 were based on treatment with 20 U/kg bodyweight of C1-INH in 1,085 episodes of HAE attacks at any body location in 57 patients. The main study end-points were time to onset of symptom relief, time to complete resolution of all symptoms and safety. No drug-related serious adverse events were reported, nor were any rebound effects observed following C1-INH administration.

About CSL Behring

CSL Behring is a global leader in the plasma protein biotherapeutics industry. Passionate about improving the quality of patients' lives, CSL Behring manufactures and markets a range of safe and effective plasma-derived and recombinant products and related services. The company's therapies are used in the treatment of immune deficiency disorders, hereditary angioedema, hemophilia, von Willebrand disease, other bleeding disorders and inherited emphysema. Other products are used for the prevention of hemolytic diseases in the newborn, in cardiac surgery, organ transplantation and in the treatment of burns. The company also operates one of the world's largest plasma collection networks, CSL Plasma. CSL Behring is a subsidiary of CSL Limited, a biopharmaceutical company with headquarters in Melbourne, Australia. For more information, visit www.cslbehring.com.

Contact:
Sheila A. Burke, Director, Communications & Public Relations
Worldwide Commercial Operations
CSL Behring
610-878-4209 (o)
484-919-2618 (c)
Sheila.Burke@cslbehring.com


'/>"/>
SOURCE CSL Behring
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. InNexus Biotechnology Announces Launch of Large Scale Primate Study of DXL625
2. RAND study finds increase in piracy and terrorism at sea
3. Merrimack Pharmaceuticals Initiates Enrollment in a Phase 1 Study of MM-121, an ErbB3 Antagonist
4. Palatin Technologies, Inc. Reports Positive Results of Phase 2a Clinical Study with PL-3994 for the Treatment of Heart Failure
5. Logical Therapeutics Inc. Announces Results of Phase 1b Clinical Study of its Naproxen Prodrug
6. Video: CSL Behring Provides $1.2M Grant for Worlds First Study of Postpartum Women with VWD, Common Bleeding Disorder
7. RainDance and Scripps to Collaborate on Targeted Sequencing for Wellderly Study
8. Preliminary Report of American Biotech Labs HIV Study Featured in Inaugural Issue of Journal of the Science of Healing Outcomes
9. Pharmasset Reports Preliminary Results of a 4-week Proof-of-Concept Combination Study of R7128 for the Treatment of Chronic Hepatitis C in Genotype 2 or 3 Non-Responders
10. ESBATech Announces Successful Completion of Phase I Clinical Study for Lead Antibody Fragment in Ophthalmic Indications
11. Germicidal UVC Lights Improve Clinical Pregnancy Rates for IVF Lab, New Study Finds
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/20/2017)... , June 20, 2017  Kibow Biotech Inc., ... to announce the issuance of a new patent covering ... hyperuricemia by the U.S. Patent and Trademark Office on ... winner of the Buzz of Bio award in 2014 ... akin to developing non-drug approaches to chronic disease. Renadylâ„¢, ...
(Date:6/20/2017)... ... June 20, 2017 , ... Do More with OHAUS , With ... a trusted supplier in the weighing industry, to extending its expertise across the entire ... reactions, immunoassays, hybridizations and more, allowing for its customers to 'Do More' ...
(Date:6/19/2017)... ... 19, 2017 , ... As Vice President, Product Services, Mr. ... implementation, support, and client process and SOP development. , Mr. Guinter brings a ... roles for service providers and top-tier pharmaceuticals, and as an independent consultant supported ...
(Date:6/19/2017)... (PRWEB) , ... June 19, 2017 , ... Tunnell ... for over 50 years. One of the biggest challenges faced by life sciences, biotech ... regulatory affairs services team is Kati Abraham , who is well known in ...
Breaking Biology Technology:
(Date:4/4/2017)... --  EyeLock LLC , a leader of iris-based identity ... and Trademark Office (USPTO) has issued U.S. Patent No. ... iris image with a face image acquired in sequence ... th issued patent. "The issuance ... multi-modal biometric capabilities that have recently come to market ...
(Date:3/30/2017)... 2017 The research team of The Hong ... fingerprint identification by adopting ground breaking 3D fingerprint minutiae recovery and ... speed and accuracy for use in identification, crime investigation, immigration control, ... ... A research team led ...
(Date:3/28/2017)... -- The report "Video Surveillance Market by ... Devices), Software (Video Analytics, VMS), and Service (VSaaS, Installation ... 2022", published by MarketsandMarkets, the market was valued at ... reach USD 75.64 Billion by 2022, at a CAGR ... considered for the study is 2016 and the forecast ...
Breaking Biology News(10 mins):