Lundbeck starts clinical phase IIa with Lu AA24493 (cEPO) in
Friedreich's ataxia in a study also ass
(Thomson Reuters ONE) - H. Lundbeck A/S strengthens its pipeline of pharmaceuticals inclinical development by initiating phase IIa clinical studies withthe innovative project Lu AA24493 in order to evaluate safety andtolerability and to explore theoretical efficacy parameters of thedrug in humans. Lundbeck expects to enrol 35-40 people suffering fromFriedreich's ataxia in this study.Lu AA24493 is a novel carbamoylated form of human erythropoietin(EPO) - a modification of EPO that results in loss of haematopoieticeffects but maintains the tissue protective effect. These tissueprotective effects translate to very positive effects in a number ofanimal models for neuronal damageThe primary objective of the study is to evaluate the safety andtolerability of two weeks treatment with a fixed dose Lu AA24493 inpatients with Friedreich's ataxia. However, this placebo-controlledprogramme may also potentially provide efficacy signals viabiomarkers."This project in Friedreich's ataxia represents Lundbeck's focus todiscover and develop innovative compounds that address unmet needsfor patients. Lu AA24493 is an example of compounds with a greatpotential for addressing a small but very severe disease," saysExecutive Vice President Anders Gersel Pedersen, Head of DrugDevelopment at Lundbeck. "Furthermore, this project represents aninnovative process in obtaining proof of principle as we look forsignals related to a biomarker as an early indicator of drugactivity".About Friedreich's ataxia[1]Friedreich's ataxia is an inherited disease that causes progressivedamage to the nervous system resulting in symptoms ranging from gaitdisturbance and speech problems to heart disease. It is named afterthe physician Nicholaus Friedreich, who first described the conditionin the 1860s. "Ataxia," which refers to coordination problems such asclumsy or awkward movements and unsteadiness, occurs in manydifferent diseases and conditions. The ataxia of Friedreich's ataxiaresults from the degeneration of nerve tissue in the spinal cord andof nerves that control muscle movement in the arms and legs. Thespinal cord becomes thinner and nerve cells lose some of their myelinsheath - the insular covering on all nerve cells that helps conductnerve impulses.Friedreich's ataxia, although rare, is the most prevalent inheritedataxia, affecting about 1 in every 50,000 people in the Caucasianpopulation. Males and females are affected equally.As with many degenerative diseases of the nervous system, there iscurrently no cure or effective treatment for Friedreich's ataxia.However, many of the symptoms and accompanying complications can betreated to help patients maintain optimal functioning as long aspossible.About Lu AA24493Lu AA24493 is a novel cytoprotective compound currently indevelopment for acute ischaemic stroke. It is chemically modified EPOby carbamylation and does not bind to the erythropoietin receptor(EPOR) and is thereby without haematopoietic side-effects. Despitethe lack of binding to EPOR, Lu AA24493 retains full cytoprotectiveproperties, demonstrating that Lu AA24493 mediates its beneficialeffects via a mechanism different from that of the classical EPOR.Lundbeck contactsInvestors: Media:Jacob Tolstrup Mads KronborgDirector, IR & Communication Media Relations+45 36 43 30 79 +45 36 43 28 51Palle Holm Olesen Kasper RiisHead of Investor Relations Media Relations+45 36 43 24 26 +45 36 43 28 33Magnus Thorstholm JensenInvestor Relations Officer+45 36 43 38 16About LundbeckH. Lundbeck A/S (LUN.CO, LUN DC, HLUKY) is an internationalpharmaceutical company highly committed to improve the quality oflife for people suffering from central nervous system (CNS)disorders. For this purpose Lundbeck is engaged in the research anddevelopment, production, marketing and sale of pharmaceuticals acrossthe world, targeted at disorders like depression and anxiety,schizophrenia, insomnia, Huntington's, Alzheimer's and Parkinson'sdiseases.Lundbeck was founded in 1915 by Hans Lundbeck in Copenhagen, Denmark,and employs today over 5,500 people worldwide. Lundbeck is one of theworld's leading pharmaceutical companies working with CNS disorders.In 2008, the company's revenue was DKK 11.3 billion (approximatelyEUR 1.5 billion or USD 2.2 billion). For more information, pleasevisit www.lundbeck.com.[1] Friedreich's Ataxia Fact Sheet; National Institute ofNeurological Disorders and Strokehttp://hugin.info/130085/R/1351815/326843.pdfThis announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Datum: 02.11.2009 - 10:00 Uhr
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