Positive Phase II clinical data for Clavis Pharma's Elacytarabine
presented at ASH Annual Meeting
(Thomson Reuters ONE) - Elacytarabine demonstrated threefold survival benefit in patientswith acute myeloid leukaemiaOslo, Norway, December 7, 2009.Clavis 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) was presented at the 51st American Society of Hematology (ASH)Annual Meeting in New Orleans, LA, USA. Elacytarabine is a novel,patented, lipid-conjugated form of the anti-cancer drug cytarabine(Ara-C) that has the potential to improve treatment outcomes inpatients with AML and other haematological malignancies (leukaemias).Elacytarabine has Orphan Drug Designation in the USA and Europe forthe treatment of AML.The poster entitled "A Phase II Multicenter Study with Elacytarabineas Second Salvage Therapy in Patients with AML" was presented bySusan O'Brien, M.D. of the University of Texas MD Anderson CancerCenter, Houston, TX, in collaboration with researchers at otherleading cancer centres and Clavis Pharma. This is the first timeclinical results of this trial for all 61 patients have beenpresented at a leading cancer congress.The poster can be downloaded fromhttp://www.clavispharma.com/Products/Scientific+posters.The data and analyses from the multicentre open-label trial showedelacytarabine to have a significantly superior survival benefitcompared to published clinical outcome data for 594 late-stage AMLpatients receiving investigators choice of treatment[1]. The resultsconfirm the positive findings from the trial announced in June 2009.Key results for elacytarabine compared to published clinical data are * Median survival three times longer (5.3 months vs. 1.5 months) * Remission rate significantly increased (14.8% vs 2.5%, p<0.0001) * Well tolerated - short-term mortality substantially lower (13% vs. 25%)Based on the encouraging results of this trial, Clavis Pharma isabout to begin a 350-patient Phase III randomised, controlledregistration study in the USA and Europe designed to demonstrate itssuperiority over the investigator's choice of the best alternativetherapy in late-stage AML patients.Clavis Pharma has also received approval to enrol patients in a PhaseII study of elacytarabine in combination with idarubicin in AMLpatients who have failed their first course of treatment.In addition to evaluating survival in all patients, the studies willanalyze patients' expression levels of the hENT1 tumour protein. ThehENT1 (human equilibrative nucleoside transporter 1) cell membranetransporter is believed to be critical for cytarabine entry intotumour cells, whereas elacytarabine enters and kills tumour cells ina hENT1-independent manner. The goal is to demonstrate that theefficacy of elacytarabine is independent of the patient's hENT1status.Geir Christian Melen, CEO of Clavis Pharma, commented: "Thesepositive clinical results give us great confidence that elacytarabinecould improve the treatment of late-stage AML patients, a group forwhich there are few effective therapeutic options. We look forward tostarting a randomised, controlled Phase III trial to furtherdemonstrate the benefit that we have already seen with elacytarabinein treating these patients.Mr Melen added, "The results represent an important proof of conceptfor our approach to developing improved cancer drugs based on ourLipid Vector Technology. This approach was recently validated in our$380 million deal with Clovis Oncology for CP-4126 to treatpancreatic and other solid tumours. Both elacytarabine and CP-4126are designed using LVT to bypass the hENT1 transporter mechanism thatlimits the efficacy of cytarabine and gemcitabine, respectively. Weare excited about the potential of both these drugs and also that, asa result of the deal with Clovis, sufficient resources are availableto drive the clinical programmes forward."Extended survival, improved remissionsIn the Phase II study, 61 patients (41 male and 20 female) with latestage AML who failed to respond or relapsed after two separate roundsof treatments received third-line therapy (also called secondsalvage) with intravenous elacytarabine. A dose of 2000 mg/m2/day wasgiven as continuous infusion for five days. The response to treatmentwas compared with a detailed historical outcome analysis of 594similar second salvage AML patients, who were treated at the MDAnderson Cancer Center (Houston, TX, USA) (published by Giles et al,Cancer 2005;104:547-54). Median overall survival in the elacytarabinestudy was an impressive three times that of the historical controlpatients (5.3 months vs. 1.5 months). The 6 month survival rate was44%.In addition, 9 patients responded to elacytarabine with a completeremission (CR) or complete remission without full recovery ofplatelet counts (CRp) as assessed by the investigator, representingan overall remission rate of 14.8 per cent. By contrast, the expectedremission rate for similar group of patients, matched for prognosticfactors as described by Giles et al. was only 2.5 per cent. Using apre-defined statistical analysis method, the improvement in outcomewas statistically highly significant (corresponding to p<0.0001). Inaddition to the 9 patients with a complete remission, 5 patientsresponded to elacytarabine with a partial response.Elacytarabine was relatively well tolerated, also by elderlypatients, and 30 day all cause mortality following treatment wassubstantially lower than published data for existing therapies (13per cent vs. 25 per cent). Out of the 61 patients treated withelacytarabine, 10 were referred for stem cell transplantationfollowing treatment, including some patients in complete remissionand others with a more modest level of clinical benefit. Stem celltransplantation represents a potential cure for life for thesepatients.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.ukNOTES FOR EDITORSAbout 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 breakthough 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.[1] Giles, F et al, Outcome of patients with acute myelogenousleukemia after second salvage therapy. Cancer (2005)104: 547-554http://hugin.info/136972/R/1359425/331345.pdfThis announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Datum: 07.12.2009 - 07:30 Uhr
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