New Octapharma 10% High Purity Immunoglobulin Enters Phase II/III Study In Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Octapharma AG announced the imminent shoot of the biggest at all times study of an intravenous immunoglobulin preparation (IVIG) in chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).
The double-blind, placebo-controlled, randomised, multicentre, adaptive, two-stage Phase 2/3 dose-finding study will investigate the vigor and safeness of Octapharma’sitting novel 10% intravenous immunoglobulin in the treatment of CIDP and, in the same time through results from additional on-going and upcoming studies, will support its regulatory filing in Europe and the US.
Commenting on the start of the search into, Kim Bj?rnstrup, Vice Chairman of Octapharma Group said, “The development of our rare 10% IVIG is part of our ongoing commitment to invest in the growth of protein based immunotherapies and in specific in IgG preparations. For 25 years, our cutting-edge research program has sought to unravel new biological entities tailored specifically around the necessarily of clinicians and patients – delivering improved quality of life because of patients and ease of pronunciation and management for hospitals.”
“Octapharma’s regular aim is not to develop just a different IVIG brand but to put at interest extensive time and preclinical resources to ensure that the new IVIG will essay outstanding features, representing tangible added precise signification for the sufferer and care giver, such in the same proportion that irregular tolerability,” added Kim Bj?rnstrup.
The development of this completely unaccustomed high immaculateness IVIG builds upon Octapharma’s experience in the district of immunoglobulin products. Octapharma’session running water leading IVIG brand has been introduced to the market in 1995 and is popularly registered in about 60 countries, including the EU and the US.
“Octapharma’s new 10% IVIG inclination be a track forward in the evolution of IVIG products. Regarding the development of the product, Octapharma has looked to optimise the characteristics of the product for improved patient outcomes, such as high tolerability even at capital infusion rates. Pre-clinical studies and given provisions from any on-going clinical burden in preparatory immunodeficiency (PI) have confirmed that a favourable tolerability profile may be expected” commented Dr Stefan Haag, Head of Octapharma’s International Immunotherapy Business Unit.
The Phase II/III think in CIDP represents another element in a series of studies to investigate Octapharma’s novel 10% IVIG instead of a range of neurologic and haematological conditions including immune thrombocytopenic purpura (ITP), Guillain-Barr? syndrome (GBS), Kawasaki disease and chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).
About Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
CIDP is a separate acquired chronic progressive or relapsing and spontaneously remitting neurological condition characterised by the agency of the gradual storming of weakness, areflexia and impaired sensation, that progressively increases1. It is reported that 4% to 17% of CIDP patients die from the illness usually since a consequence of respiratory ill success or pulmonic interpolation, about 50% prescribe persistent treatment, and 13% are permanently disabled2. CIDP is generally considered to be one autoimmune complaint caused by means of the activation of autoimmune mechanisms resulting from exposure to environmental antigens. These antigens may trigger immune responses that captious react by antigens in the myelin case of peripheral nerves3. Over the last 20 years, high-dose IVIG has become any effective and sure therapeutic option for CIDP. Because of the freedom from stiffness of its application, IVIG has adorn the preferred treatment for children with CIDP4,5. A recently published placebo-controlled meditate on on CIDP patients confirmed this short designate behoof and showed sustained benefit from repeated IVIG treatment6.
(1) Hughes RA, Allen D, Makowska A, Gregson NA. Pathogenesis of chronic inflammatory demyelinating polyradiculoneuropathy. J Peripher Nerv Syst 2006; Mar;11(1):30-46.
(2) Hughes RA. Management of of long duration inflammatory demyelinating polyradiculoneuropathy. Drugs 2003;63(3):275-87.
(3) Hughes RA, Hadden RD, Gregson NA, Smith KJ. Pathogenesis of Guillain-Barre syndrome. J Neuroimmunol 1999 Dec;100(1-2):74-97.
(4) Simmons Z, Wald JJ, Albers JW. Chronic incendiary demyelinating polyradiculoneuropathy in children: II. Long-term follow-up, with similitude to adults. Muscle Nerve 1997 Dec;20(12):1569-75.
(5) Simmons Z, Wald JJ, Albers JW. Chronic inflammatory demyelinating polyradiculoneuropathy in children: I. Presentation, electrodiagnostic studies, and initial clinical run, with comparison to adults. Muscle Nerve 1997 Aug;20(8):1008-15.
(6) Hughes RA, Donofrio P, Bril V, Dalakas MC, Deng C, Hanna K, et al. Intravenous immune globulin (10% caprylate-chromatography purified) for the treatment of chronic inflammatory demyelinating polyradiculoneuropathy (ICE study): a randomised placebo-controlled trial. Lancet Neurol 2008 Jan 4;7(2):136-44.
September 07 2010 03:39 am | Immune System