Navigation Links
CSL Behring Study in Animal Models Shows Feasibility of Developing a Half-Life Extended Recombinant FVIIa that Retains Biologic Activity
Date:12/10/2007

In data presented at the ASH 49th annual meeting recombinant factor VIIa-albumin fusion protein seen as first step toward more convenient

treatment option for hemophilia patients with inhibitors

ATLANTA, Dec. 10 /PRNewswire/ -- CSL Behring today announced the results of a pre-clinical study that show for the first time it is feasible to genetically fuse Factor VIIa (FVIIa) to human albumin, prolonging the half- life of this therapeutic protein while retaining its biologic activity. In the study, which was presented at the American Society of Hematology 49th Annual Meeting and Exposition, the half-life of recombinant VIIa-albumin fusion protein (rVIIa-FP) was shown to be extended 6-to-9 fold compared to wild type rFVIIa. Additionally, rVIIa-FP demonstrated a biologic activity comparable to wild type rFVIIa.

Recombinant factor VIIa (rFVIIa) may be used to control bleeding episodes in hemophilia patients with inhibitors. These patients develop an immune response that inhibits the substituted clotting factor from stopping a bleeding episode. However, rFVIIa has a short half-life of approximately 2.5 hours. This necessitates multiple injections, which are inconvenient for both physicians and patients, particularly during surgical intervention.

"A major unmet need in hematology is improving the pharmacokinetic parameters of coagulation factors, such as half-life, while retaining full hemostatic activity," said Dr. Stefan Schulte, Head Pre-clinical R&D, CSL Behring GmbH and lead investigator of the study. "The pharmacological properties of rVIIa-FP seen in our study could one day facilitate a single dosing regimen of one injection per bleeding event, as well as significantly reduce the number of injections hemophilia patients with inhibitors need during surgical interventions."

Recombinant VIIa-FP represents CSL Behring's initial corporate foray into research with recombinant coagulation product technology.

"CSL Behring is pleased to be at the forefront of this exciting development in hemophilia treatment, which is consistent with our mission to improve the lives of patients with bleeding disorders," said Dr. Andrew Cuthbertson, Chief Scientific Officer at CSL Ltd., parent company of CSL Behring. "By increasing convenience and compliance, rVIIa-FP has the potential to benefit hemophilia patients with inhibitors and the physicians who treat those patients. We look forward to continuing our research and accumulating additional data to validate the results seen in our pre-clinical study of this molecule."

Today's Presentation: Study Design

Genetic fusion to albumin is an efficient way to extend the half-life of small proteins, but so far it has not been successfully used for the half-life extension of complex proteins. In the presented proof-of-principle study, rVIIa-FP was generated by genetic engineering, expressed in mammalian cell culture, purified and characterized. The rVIIa-FP displayed full biological activity and 6 to 9-fold extended half-life compared to either Novoseven(R)(1), a recombinant FVIIa, or rVIIa control protein in a pre-clinical rat model. The superior pharmacological properties of the rVIIa-FP could facilitate a single dosing regimen of one injection per bleeding event for treatment of hemophilia inhibitor patients.

About Hemophilia with Inhibitors

In some patients with hemophilia, the immune system produces an antibody that blocks the action of the substituted coagulation factor and prevents clot formation. This antibody is known as an inhibitor, and its presence makes treatment of bleeding episodes more difficult. The reason inhibitors develop is unknown, although people with hemophilia have the greatest risk for developing an inhibitor during childhood. The incidence of inhibitors is highest among those with severe hemophilia, followed by moderate and mild deficiency. The risk of inhibitor development is higher if someone in the patient's family also has an inhibitor, and is more frequent among African Americans.(2)

About CSL Behring

CSL Behring is a global leader in the protein biotherapeutics industry. Passionate about saving and 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 rare diseases such as immune deficiency disorders, 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, ZLB Plasma. CSL Behring is a subsidiary of CSL Limited, a biopharmaceutical company with headquarters in Melbourne, Australia. For more information, visit http://www.cslbehring.com.

Contacts: Sheila A. Burke Jeff Hoyak

Director, Communications & Public Relations MCS Public Relations

Worldwide Commercial Operations, CSL Behring +1-908-884-6753

+1-610-878-4209 jeffh@mcspr.com

Sheila.Burke@cslbehring.com

(1) NovoSeven is a registered trademark of Novo Nordisk Health Care AG.

(2) National Hemophilia Foundation website http://www.hemophilia.org

accessed 11.9.07


'/>"/>
SOURCE CSL Behring
Copyright©2007 PR Newswire.
All rights reserved

Related medicine technology :

1. CSL Behring Reaches Primary Endpoint in Clinical Study of C1-INH for Treatment of Hereditary Angioedema
2. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
3. EDAP Announces Launch of Clinical Study Combining HIFU and Chemotherapy for Localized Aggressive High Risk Prostate Cancer
4. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
5. Allos Therapeutics Initiates Study of PDX in Patients with Cutaneous T-Cell Lymphoma
6. Multiple Myeloma Research Consortium (MMRC) Partners with Novartis to Advance Phase II Study of Deacetylase Inhibitor
7. Potential Safety Issue Identified in Ongoing Phase 2 Clinical Study of HCV-796
8. Study Suggests High-Dose Fish Oil May Significantly Improve Behavior in Children with ADHD
9. MicroDose Announces Positive Results From the QDose Inhaled Insulin Glucose Clamp Study
10. Video: Landmark Study in The Lancet: Patients Treated With Betaseron(R) After First MS Attack Experienced Significant Delay in MS Progression
11. MacroGenics Begins Global Phase 2/3 Protege Study in Recent-onset Type 1 Diabetes Mellitus
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/12/2017)... Oct. 12, 2017 AVACEN Medical , Inc. ... with their  2017 New Product Innovation Award for Its ... primary and secondary medical device market research by Frost & ... first-to-market OTC, drug-free pain relief product, the AVACEN 100, offers ... treating fibromyalgia widespread pain. ...
(Date:10/11/2017)... , Oct. 11, 2017  Caris Life Sciences ® ... fulfilling the promise of precision medicine, today announced that ... Caris, Precision Oncology Alliance™ (POA) as its 17 th ... the St. Jude Crosson Cancer Institute will help develop ... use of tumor profiling, making cancer treatment more precise ...
(Date:10/10/2017)... Pa. , Oct. 10, 2017   West ... in innovative solutions for injectable drug administration, today shared ... West,s ID Adapter for improving the intradermal administration of ... Fourth Skin Vaccination Summit in May 2017 by Dr. ... Lead, Polio Department, World Health Organization (WHO), and recently ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... 2017 , ... “The Journey: From the Mountains to the Mission Field”: the ... in the Philippines. “The Journey: From the Mountains to the Mission Field” is the ... She has taught all ages and currently teaches a class of ladies at her ...
(Date:10/12/2017)... Francisco, CA (PRWEB) , ... October 12, 2017 ... ... Dr. Cheng, are now treating sleep apnea using cutting-edge Oventus O2Vent ... apnea, a serious sleep disorder characterized by frequent cessation in breathing. Oral appliances ...
(Date:10/12/2017)... ... October 12, 2017 , ... IsoComforter, Inc. ( https://isocomforter.com ... the introduction of an innovative new design of the shoulder pad. The shoulder ... maximum comfort while controlling your pain while using cold therapy. By utilizing ice and ...
(Date:10/12/2017)... Rockville, Maryland (PRWEB) , ... October 12, 2017 ... ... a magnetic drug delivery system that we intend to develop to enable prevention ... regimens can lead to severe hearing loss, especially in pediatric patients. For cisplatin, ...
(Date:10/12/2017)... ... October 12, 2017 , ... Leading pediatric oncology experts ... Washington, D.C., for the 49th Congress of the International Society of Paediatric Oncology ... of the Center for Cancer and Blood Disorders at Children’s National, and ...
Breaking Medicine News(10 mins):