To NASDAQ OMX Copenhagen A/S
Investor Nyhed nr. 02-13 / København, 7. marts 2013
Topotarget har i dag meddelt, at kliniske data (videnskabeligt resumé) vil blive præsenteret på 2013-årsmødet for American Association for Cancer Research (AACR) den 6.-10. april 2013.
Nedenfor ses det videnskabelige kliniske resumé, der nu er tilgængeligt på AACR’s hjemmeside (http://www.aacr.org/).
Abstract 1172, Monday, April 8, 2013 at 1.00-5.00 pm, Hall A-C Poster Section 2.
Phase I Study of Histone Deacetylase Inhibitor Belinostat in Combination with Warfarin in Patients with Solid Tumors or Hematological Malignancies
Neeraj Agarwal1, Mark L. Wade1, Julia Batten1, Cynthia Davidson1, Show-Li Sun2, Sunil Sharma1. 1University of Utah Huntsman Cancer Institute, Salt Lake City, UT; 2Spectrum Pharmaceuticals, Inc., Irvine, CA.
Background: The family of Histone Deacetylase (HDAC) enzymes serves as important epigenetic regulators of gene expression through modulation of acetylation on important histone and non-histone proteins. Aberrant acetylation of histones can alter gene expression believed to be important in the tumorigenic process. Belinostat, a potent inhibitor of HDAC proteins has demonstrated antitumor activity in animal models and in humans. The purpose of this study was to examine the pharmacokinetic and pharmacodynamic properties of warfarin in combination with belinostat and to evaluate the safety profile of belinostat with concomitant warfarin.
Methods: Eligible patients enrolled on the study received 5 mg PO warfarin 14 days prior to administration of belinostat. Belinostat was administered as an iv infusion, 1000mg/m2 over 30 minutes for 5 consecutive days every 21 days. On day 3, cycle 1 of belinostat treatment, a second dose of 5mg PO warfarin was administered 2 hours prior to belinostat. Pharmacokinetic blood samples were obtained during cycle 1 of the study to measure warfarin and belinostat metabolism. Toxicities were monitored regularly throughout treatment and response was monitored according to standard of care guidelines.
Results: 18 patients, with solid tumors or hematologic malignancies, treated with belinostat and warfarin were included in this analysis. Median age was 55 years (31-77). 11 (61%) patients were male and 7 (39%) patients were female. The most common Grade 1 or 2, toxicities observed during the study were anemia (78%), fatigue (72%) and nausea (61%). The most frequent Grade 3 or 4 toxicities were nausea (11%) and hyperuricemia (11%). No Grade 3 or 4 thrombocytopenia or neutropenia were reported. No treatment related Grade 5 toxicities were reported. During cycle 1 no patient experienced treatment delays or discontinued study as result of treatment related toxicity.
Conclusion: Belinostat was generally well tolerated in patients with solid tumors or hematologic malignancies with the major toxicity being anemia, fatigue or nausea. Pharmacokinetic results will be presented at the conference.
For yderligere oplysninger kontakt venligst:
Topotarget A/S
Anders Vadsholt, CEO: Direkte: +45 39178345
Baggrundsoplysninger
Om Topotarget
Topotarget (NASDAQ OMX: TOPO) er et internationalt biofarmaceutisk selskab med hovedsæde i København. Selskabet beskæftiger sig med klinisk udvikling og registrering af onkologiprodukter. Topotarget fokuserer i samarbejde med Spectrum Pharmaceuticals, Inc. på udviklingen af dets førende lægemiddelkandidat, belinostat, som har vist positive resultater i behandling af blodkræftsygdomme og solide kræfttumorer opnået ved både enkeltstof- og kombinationsbehandling. For yderligere oplysninger henvises til www.topotarget.com.
Topotarget Safe Harbor Statement
Denne meddelelse kan indeholde fremadrettede udsagn, herunder udsagn om Topotarget A/S' forventninger til udviklingen af selskabets kliniske pipeline samt med hensyn til forventet likviditetsforbrug. Sådanne udsagn er forbundet med risici og usikkerhed, hvoraf mange ligger uden for Topotarget A/S' kontrol, og kan medføre, at de opnåede resultater afviger væsentligt fra de beskrevne. Topotarget A/S har ingen hensigt om og påtager sig ingen forpligtelse til at opdatere eller ændre fremadrettede udsagn, hverken som følge af fremkomsten af nye oplysninger, fremtidige begivenheder eller på anden måde, medmindre dansk lovgivning kræver det.
