Kiobrina(TM) shows positive phase II results in preterm infants
(Thomson Reuters ONE) - Stockholm, Sweden - November 25, 2009 - Biovitrum AB (STO: BVT) todayannounced that the first of two clinical phase II studies, designedto together show proof of concept of Kiobrina(TM) (rhBSSL) in preterminfants, has been completed. The results show statisticallysignificant improvement in the growth velocity in preterm infantswhen Kiobrina(TM) was added to infant formula compared to placebo.The safety profile was comparable to that of placebo and no drugrelated serious adverse events were reported.The study was a prospective randomized double-blind crossover studywhere Kiobrina(TM), or placebo, was administered in preterm infantformula during one week of treatment. All infants were born beforeweek 32 of gestational age. The next step in the establishment ofproof of concept is the completion of the second study where preterminfants are treated with Kiobrina(TM) administrated in pasteurizedbreast milk. Results from this second trial are expected in thebeginning of 2010."The initial Phase II clinical results in this high medical needpopulation are very encouraging. If the ongoing parallel study inpreterm infants fed with pasteurized breast milk is also positive, wehave proof of concept and will advance the program into aregistrational stage," said Martin Nicklasson, CEO of Biovitrum.About KiobrinaKiobrina is a recombinant human bile-salt-stimulated lipase (rhBSSL)developed by Biovitrumfor enzyme replacement therapy to improve growth and development inpreterm infants receiving pasteurized breast milk and/or formula. Therationale for substitution of rhBSSL in pasteurized breast milk orinfant formula is to restore the natural lipase activity level thatis either lost on pasteurization or totally absent in formula.About BiovitrumBiovitrum is an international pharmaceutical company that marketsspecialist pharmaceuticals in several regions. Using its expertiseand experience Biovitrum takes scientific innovation to patients withsignificant unmet medical need. Research expertise and capabilitiesare focused on development and production of biotechnologytherapeutics within our prioritized areas of hemophilia,inflammation/autoimmune diseases, cancer supportive care andenhancement of lipid absorption. The company has revenues ofapproximately SEK 1.2 billion and around 400 employees. The companyhead office is located in Sweden and it is listed on the StockholmOMX Nordic Exchange. For more information please visitwww.biovitrum.com.For more information please contact:Biovitrum AB (publ)Erik Kinnman, Vice President Investor RelationsPhone: +46 73 422 15 40erik.kinnman(at)biovitrum.comMartin Nicklasson, CEOPhone. +46 8 697 2327The clinical phase II studies has been carried out partially withresearch funding from the European Community's Sixth FrameworkProgram (The Early Nutrition Programming Project,www.metabolic-programming.org). The press release reflects only theauthor's views and does not necessarily reflect the views of theEuropean Community or European Commission or their future policy,and they are not liable for any use that may be made of theinformation contained herein. The information in this document isprovided as is and no guarantee or warranty is given that theinformation is fit for any particular purpose. The user thereof usesthe information at its sole risk and liability.Biovitrum AB (publ) may be required to disclose the informationprovided herein pursuant to the Swedish Securities Markets Act. Theinformation was provided for public release on November 25, 2009 at08:30 a.m. CET.http://hugin.info/134557/R/1357039/329994.pdfThis announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Datum: 25.11.2009 - 08:30 Uhr
Sprache: Deutsch
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