Biotie reports positive top-line data from clinical study with VAP-1 antibody in rheumatoid arthriti
(Thomson Reuters ONE) - BIOTIE THERAPIES CORP. STOCK EXCHANGE RELEASE 19 January 2010 at 9.00 a.m.Biotie reports positive top-line data from clinical study with VAP-1 antibody inrheumatoid arthritis patients - BTT-1023 is well tolerated and shows signals oftherapeutic activityBiotie today reported that it has successfully completed a clinical trial withits fully human VAP-1 monoclonal antibody (BTT-1023) in rheumatoid arthritispatients.The study evaluated the safety, tolerability, and pharmacokinetics of repeateddoses of intravenously administered antibody in 24 rheumatoid arthritis patientswith an inadequate treatment response to methotrexate. The antibody,administered at repeated doses of up to 8 mg/kg in combination withmethotrexate, was generally well tolerated, and no serious or severe adverseevents were reported in the study subjects. The pharmacokinetic characteristicsof BTT-1023 are consistent with those expected for an intravenously administeredmonoclonal antibody intended for chronic conditions.The study was not designed to enable formal statistical evaluation oftherapeutic activity. However, in several assessments of treatment effect suchas Disease Activity Score based on 28 joint assessment (DAS28) criteria,American College of Rheumatology (ACR) criteria, physician's global assessmentand erythrocyte sedimentation rate, responses in higher dose groups were greaterthan in the placebo group. Several patients receiving higher doses of BTT-1023reached an ACR50 response (i.e. a 50% reduction in their ACR score) duringtreatment."We are very pleased with the good tolerability and pharmacokinetic profile thatwe saw with BTT-1023 in this study", said Timo Veromaa, President and CEO ofBiotie Therapies Corp. "These data, combined with signals of therapeuticactivity, provide, in our opinion, a good basis for proceeding into largertherapeutic trials with BTT-1023. We plan to analyze and discuss these data withour partner, Roche, to establish the optimal way to continue the clinicaldevelopment program. We expect a decision from Roche, regarding its option rightto in-license BTT-1023 at this stage of development, during the first half of2010."Turku, January 19, 2010Biotie Therapies Corp.Timo VeromaaPresident and CEOFor further information, please contact:Virve Nurmi, Investor Relations Managertel. +358 2 274 8911, e-mail: virve.nurmi(at)biotie.comwww.biotie.com Distribution:Helsinki Stock ExchangeMain MediaABOUT STUDY BTT12-CD015Study BTT12-CD015, conducted within the EU, was a randomized,placebo-controlled, double-blind multiple ascending dose study conducted in 4sequential cohorts of 6 patients. Within each cohort, 5 patients were randomizedto receive active drug and 1 patient to receive placebo under double-blindconditions. The BTT-1023 doses in the sequential cohorts were 1, 2, 4 and 8mg/kg. In this 4 month study, 5 doses of study drug were administeredintravenously at 2 week intervals, with post-treatment follow-up continuing for9 weeks after the last dose.The study subjects were required to have active rheumatoid arthritis with apredefined level of breakthrough symptoms while on a stable background regimenof methotrexate. Safety and tolerability were assessed with adverse eventinquiries and comprehensive laboratory analyses, while treatment response wasassessed with a number of subjective and objective assessments that are widelyused in rheumatoid arthritis trials.A similarly designed companion study in patients with psoriasis (BTT12-CD106) iscurrently underway, with expected completion by the end of Q2/2010.ABOUT BTT-1023 AND VAP-1BTT-1023 is a fully human monoclonal antibody based on Medarex, Inc.'s HuMabtechnology. The antibody targets Vascular Adhesion Protein 1 (VAP-1), anendothelial adhesion molecule. Inhibiting VAP-1 reduces inflammation byregulating the migration of leukocytes, or white blood cells, to inflamedtissues. Pathological accumulation of white blood cells in tissue is a commonfeature in many autoimmune diseases, such as rheumatoid arthritis, ulcerativecolitis, and psoriasis.Biotie and Roche have signed an option agreement for the antibody programtargeting VAP-1. Under the terms of the agreement, Roche has an exclusive optionright to an exclusive, worldwide license agreement for Biotie's fully humanantibody targeting VAP-1, excluding Japan, Taiwan, Singapore, New Zealand, andAustralia where rights are licensed to Seikagaku Corporation. The initial optionright will end upon completion of Phase I. Roche may extend the option right tolater development points by paying additional fees. Biotie will retain allrights to the program until a license is granted to Roche.ABOUT BIOTIE THERAPIESBiotie is a drug discovery and development company focused on central nervoussystem and inflammatory diseases. It has a broad range of innovative smallmolecule and biological drug candidates at different stages of clinical andpre-clinical development. Biotie's products address diseases with high unmetmedical need and significant market potential, including addiction and psychoticdisorders, rheumatoid arthritis, psoriasis and chronic obstructive pulmonarydisease (COPD). The most advanced product, nalmefene for alcohol dependence, iscurrently in phase III clinical development by licensing partner H. LundbeckA/S.The commercial value of the pipeline has been demonstrated through existingalliances with top-tier global pharmaceutical companies such as Lundbeck, Rocheand Pfizer. Biotie has operations in Turku, Finland and Radebeul, Germany.Biotie shares are listed on NASDAQ OMX Helsinki Ltd.For more information, please refer to www.biotie.com [HUG#1374619]
Weitere Infos zu dieser Pressemeldung:Unternehmensinformation / Kurzprofil:Bereitgestellt von Benutzer: hugin
Datum: 19.01.2010 - 08:02 Uhr
Sprache: Deutsch
News-ID 11080
Anzahl Zeichen: 0
contact information:
Town:
Kategorie:
Diese Pressemitteilung wurde bisher
225 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"
Biotie reports positive top-line data from clinical study with VAP-1 antibody in rheumatoid arthriti"
steht unter der journalistisch-redaktionellen Verantwortung von
Biotie Therapies Oyj
(
Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum
Haftungsauschluß (gemäß
TMG - TeleMedianGesetz) und dem
Datenschutz (gemäß der
DSGVO).
TURKU, FINLAND -- (Marketwired) -- 05/10/13 -- BIOTIE THERAPIES CORP. STOCK EXCHANGE RELEASE 10 May 2013 at 9.00 a.m.Biotie Therapies today announced the start of a Phase 2 clinical study evaluating nepicastat (SYN117) in cocaine dependence. The Nat ...
TURKU, FINLAND -- (Marketwired) -- 05/06/13 -- Biotie today announced that its partner H.Lundbeck A/S (Lundbeck) has launched Selincro in the United Kingdom. According to the terms of the license agreement between Biotie and Lundbeck for Selincro, B ...
TURKU, FINLAND -- (Marketwired) -- 04/22/13 -- BIOTIE THERAPIES CORP. STOCK EXCHANGE RELEASE 22 April 2013 at 9:00 a.m.Biotie today announced that its partner H.Lundbeck A/S (Lundbeck) has started launching Selincro™ in the first European markets, ...
