Positive Phase II clinical data for Clavis Pharma's elacytarabine to
be presented at ASH Annual Meet
(Thomson Reuters ONE) - Oslo, Norway, 4 December 2009Clavis Pharma ASA (OSE: CLAVIS) announces that positive clinical datafrom its Phase II study with its lead cancer product candidateelacytarabine in patients with late-stage acute myeloid leukaemia(AML) will be presented at the 51st American Society of Hematology(ASH) Annual Meeting in New Orleans, LA, USA, tomorrow at at 5:30 PM- 7:30 PM (PST) in Hall E (Ernest N. Morial Convention Center).Elacytarabine is a novel, patented, lipid-conjugated form of theanti-cancer drug cytarabine (Ara-C) that has the potential to improvetreatment outcomes in patients with AML and other haematologicalmalignancies (leukaemia's). Elacytarabine has Orphan Drug Designationin the USA and Europe for the treatment of AML.The poster entitled "A Phase II Multicenter Study with Elacytarabineas Second Salvage Therapy in Patients with AML" will be presented bySusan O'Brien, MD, University of Texas MD Anderson Cancer Center,Houston, TX, in collaboration with researchers at other leadingcancer centres and Clavis Pharma. This is the first time clinicalresults of this trial for all 61 patients are presented at a leadingcancer congress.For further information, please contact:Geir Christian MelenChief Executive OfficerOffice : +47 24 11 09 50Mobile : +47 91 30 29 65E-mail : geir.christian.melen(at)clavispharma.comGunnar ManumChief Financial OfficerOffice : +47 24 11 09 71Mobile : +47 95 17 91 90E-mail : gunnar.manum(at)clavispharma.comFor international press enquiries:Mark Swallow / Nina Enegren / David DibleCitigate Dewe RogersonOffice : +44 207 282 2948E-mail : clavispharma(at)citigatedr.co.ukAbout LeukaemiaApproximately 300,000 new cases of leukaemia are diagnosed globallyeach year, resulting in around 220,000 deaths. Leukaemia represents amarket with high unmet medical needs, which may open for acceleratedapproval processes to expedite market access for new drugs. It is asegmented market covering a broad variety of disorders. A majorclinical concern is the high rate of disease recurrence. Thefive-year survival for the most common acute leukaemia type, acutemyeloid leukaemia (AML), is in the range of 5-10% for treated elderlypatients, and approximately 30% for treated younger adults. The AMLmarket is estimated to be a multi-hundred USD market and is expectedto grow significantly over the coming years.About Clavis PharmaClavis Pharma ASA is a clinical stage oncology focused pharmaceuticalcompany based in Oslo, Norway with a portfolio of novel anti-cancerdrugs in development. These potential breakthrough products are NewChemical Entities (NCEs) made using Clavis Pharma's Lipid VectorTechnology (LVT) chemistry to introduce new properties to alreadyestablished, commercially successful drugs. Data generated suggeststhe resulting patentable NCEs offer improved efficacy and reducedside effects through enhanced pharmacokinetic properties, greatertissue penetration, altered metabolism and, in certain cases,additional modes of action.Clavis Pharma's has several drug candidates in formal developmentstudies: * Elacytarabine, an improved form of Ara-C, a leukaemia drug - about to commence a Phase III randomized, controlled registration study in late-stage acute myeloid leukaemia; * Intravenous CP-4126, an improved version of gemcitabine - currently in a Phase II comparative study with gemcitabine for the treatment of pancreatic cancer;. * Oral CP-4126 - currently being evaluated in an escalating dose Phase I study in solid tumours; and * CP-4200, an azacitidine derivative - in preclinical development for myelodysplastic syndrome (MDS), often a precursor to myeloma or leukaemia.Clavis Pharma intends to commercialise its products through strategicalliances and partnerships with experienced oncology businesses and,where and when commercially appropriate, by establishing its ownsales and marketing capabilities. CP-4126 is licensed to ClovisOncology in Americas and Europe. Clavis Pharma has retained rights inother territories and an option to co-promote CP-4126 in Europe.The shares of Clavis Pharma ASA are listed on the Oslo Stock Exchange(ticker: CLAVIS).DisclaimerThe information contained herein shall not constitute an offer tosell or the solicitation of an offer to buy, nor shall there be anysale of the securities referred to herein in any jurisdiction inwhich such offer, solicitation or sale would be unlawful prior toregistration, exemption from registration or qualification under thesecurities laws of any such jurisdiction.This news release contains forward-looking statements and forecastsbased on uncertainty, since they relate to events and depend oncircumstances that will occur in the future and which, by theirnature, will have an impact on results of operations and thefinancial condition of Clavis Pharma. There are a number of factorsthat could cause actual results and developments to differ materiallyfrom those expressed or implied by these forward-looking statements.Theses factors include, among other things, risks associated withtechnological development, the risk that research & development willnot yield new products that achieve commercial success, the impact ofcompetition, the ability to close viable and profitable businessdeals, the risk of non-approval of patents not yet granted anddifficulties of obtaining relevant governmental approvals for newproducts.No expressed or implied representations or warranties are givenconcerning Clavis Pharma or the accuracy or completeness of theinformation or projections provided herein, and no claims shall bemade by the recipient hereof by virtue of this Information Memorandumor the information or projections contained herein. Anyrepresentations or warranties made to an investor in Clavis Pharmawill be subject to separate sale and purchase agreements to benegotiated between the parties.Clavis Pharma(TM) is a registered trademark of Clavis Pharma ASA.http://hugin.info/136972/R/1359267/331264.pdfThis announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Datum: 04.12.2009 - 14:23 Uhr
Sprache: Deutsch
News-ID 9289
Anzahl Zeichen: 0
contact information:
Town:
London
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 431 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Positive Phase II clinical data for Clavis Pharma's elacytarabine to
be presented at ASH Annual Meet"
steht unter der journalistisch-redaktionellen Verantwortung von
Clavis Pharma ASA (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
