New phase II data presented at ECCO 15 - 34th ESMO Congress
reinforces exciting potential of Algeta'
(Thomson Reuters ONE) - Oslo, Norway, 22 September 2009 - Algeta ASA (OSE:ALGETA), the cancertherapeutics company, announces that new clinical data from threephase II clinical trials with Alpharadin have been presented at thejoint 15th Congress of the European CanCer Organisation (ECCO) and34th Congress of the European Society for Medical Oncology (ESMO)held in Berlin, Germany (20-24 September 2009).Alpharadin is Algeta's lead cancer therapeutic and has recently beenpartnered with Bayer for its future development andcommercialization. It is the first in a new class of alpha-emittingpharmaceuticals ('alpha-pharmaceutical') and is based on radium-223.Alpharadin is in a global phase III clinical trial (ALSYMPCA)designed to confirm its overall survival benefit and safety as atargeted treatment for bone metastases in men with hormone-refractoryprostate cancer (HRPC). Alpharadin is administered as a simpleinjection and has a unique mode of action whereby it targets bonemetastases specifically and exerts a highly localized effect on tumorcells while minimizing damage to normal surrounding tissues.The Alpharadin phase II efficacy and safety program comprised threetrials (BC1-02, BC1-03 and BC1-04) and involved 286 individuals. Itwas designed to provide detailed information on the safety andtherapeutic efficacy of different doses of Alpharadin in HRPCpatients, as well as evaluating its ability to relieve pain caused bybone metastases in symptomatic patients. In all three phase II trialscompleted, the primary efficacy endpoints were met while providingcompelling evidence of the benign safety profile of Alpharadin. Thenew data presented this week at the ECCO 15 - 34th ESMO congressconfirm these key clinical characteristics of Alpharadin treatmentand are outlined below in more detail.Andrew Kay, Algeta's President & CEO said, "The clinical data fromour comprehensive phase II program fully support our earlier findingsand reinforce our confidence that Alpharadin represents an excitingpotential new treatment for cancer patients with bone metastases.With our new partner Bayer, we are committed to progressingAlpharadin through the final stages of development and onto themarket where we believe its use will offer significant clinicalbenefits to patients with bone metastases. I would like to thank allthe researchers involved for their excellent work in developingAlpharadin thus far and for their continued support in the phase IIItrial."Clinical resultsBC1-02Two-year follow-up data from a 64-patient efficacy and safety studyevaluating survival and long-term toxicity in HRPC patients with bonemetastases (Alpharadin vs. placebo) were presented in a poster byProf. Oyvind Bruland (Norwegian Radium Hospital, Oslo, Norway).Sub-group analyses based on disease status at inclusion andpre-treatment with external beam radiotherapy were also reported.Earlier results from this trial were published by Nilsson et al. inthe Lancet Oncology (2007) 8: 587-594.The key findings were that at 24 months, ten of 33 patients (30%) whoreceived Alpharadin and four of 31 patients (13%) in the placebogroup were alive. Median survival was 65 weeks compared with 46weeks, respectively (on an Intent to treat (ITT) basis). The mediansurvival was more than 40% longer in the Alpharadin group at alllevels of extent of disease (EOD = number of "hot-spots" of bonemetastasis identified on a bone scan: <6; 6-20; >20; super-scan (i.e.distributed throughout the entire skeleton)).The largest absolute difference occurred in patients with lowest EOD;107 weeks for Alpharadin and 68 weeks for placebo and, in general,the therapeutic benefit of Alpharadin treatment seems to be greaterin fitter patients than for those with extensive bone metastases.However, the relative improvement in survival was maintainedirrespective of extent of disease at the start of treatment.Furthermore, a benign side effect profile was documented followingrepeated Alpharadin treatment, and no long term haematologicaltoxicity was reported.BC1-03Final results from the 100-patient BC1-03 study investigating thepain-relieving effects and dose-response relationship after a singledose of Alpharadin were presented in a poster by Prof. Sten Nilsson(Karolinska Hospital, Stockholm, Sweden). Preliminary findings fromthis trial were first announced in August 2008.The trial met its primary endpoint by showing that a single dose ofAlpharadin alleviated pain in a dose-dependent manner, with the mostprominent effects seen in patients receiving the highest dose. Thestudy also showed a dose-dependent reduction in bone alkalinephosphatase (ALP) ranging from no effect in the lowest dose group toa marked reduction in the higher dose groups. ALP is a severitymarker of bony metastatic disease and of prognostic importance.Again, Alpharadin was found to be well tolerated at all doses,confirming the benign side-effect profile seen in other clinicalstudies.The BC1-03 trial involved 100 men with HRPC and painful bonemetastases, who were randomized in a double-blind dose-ranging studyto receive one of four dose levels: 5, 25, 50 or 100 kBq/kg b.w. ofradium-223. Median age, baseline PSA (prostate cancer specificantigen) and baseline patients' diary Visual Analogue Score (VAS)were 70 years, 149 µg/L and 42 mm, respectively. The primary efficacyendpoint was Pain Index (PI) based on a combination of the change indiary pain rating (VAS scale) and the change in analgesic consumptionduring a 16-week period. Pain and physical function were alsomeasured using BPI (Brief Pain Inventory).At eight weeks after injection there were 40, 63, 56 and 71%responders (including only pain responders with Pain Index 1-4,minimal to complete pain response) in the four dose levels: 5, 25, 50or 100 kBq/kg b.w., respectively. Within each dose group, for theresponders, a significant pain-relieving effect was observed in thepatients' diary VAS score. Median decreases were -15, -30, -26 and-22 mm (p values all highly significant) respectively. The painresponse improved gradually from 2-8 weeks, with the best effects inthe highest dose group. 33% of the patients in the 5 and 25 kBq/kggroups had increased use of analgesic compared to 10% of the patientsin the two highest dose groups after four weeks. Improvements in BPIpain severity and functional interference index confirmed progressiveimprovements up to eight weeks. A significant reduction was seen inbone-ALP for the highest dose level (p<0.0001 at week 4). Thehaematological toxicity was generally mild and not clinicallysignificant.BC1-04The results from the 122-patient BC1-04 efficacy and safety studywere presented in an oral presentation by Dr. Chris Parker (Instituteof Cancer Research and Royal Marsden Hospital, Sutton, UK), who isprincipal investigator of the ALSYMPCA phase III study. The study wasdesigned to compare the PSA response rate of three different repeatdoses of Alpharadin, as well as the effect of dose on changes in PSA,b-ALP and toxicity. Preliminary results from this trial were firstannounced in January 2009.The study met the primary endpoint, showing a significant doseresponse for % PSA responders. In addition to the biochemicalevidence of efficacy, Alpharadin demonstrated a benign side-effectprofile and was well tolerated at all doses. No patients stoppedstudy treatment for toxicity and the most common adverse events weregastro-intestinal and musculo-skeletal, with no evidence of adose-effect. Grade 3 or 4 neutropenia was not seen. Grade 3 or 4thrombocytopenia occurred in two patients, one from each of the twolower dose groups.The trial involved 122 men with HRPC and bone metastases but noevidence of metastases in other tissues, a castrate testosterone,Eastern Cooperative Oncology Group (ECOG) performance status 0-2, andPSA progression according to the PSA Working Group criteria. Theywere randomized to one of three Alpharadin dose groups: 25, 50 or 80kBq/kg, given once every six weeks for three cycles. The main outcomewas PSA response (defined as a 50% decline confirmed >19 days later).121 eligible patients (median age 70 years, median baseline PSA 127.6ng/ml) were analyzed by ITT. 37 (31%) had received priorchemotherapy. 107 (88%) received all three Alpharadin treatmentsover 12 weeks. Confirmed PSA response was seen in 0%, 6% and 13% inthe 25, 50 and 80 kBq/kg groups, respectively (p=0.0297 test for doseresponse). The median change in PSA at week 16 was 71%, 42% and 24%,respectively (p=0.050), and in b-ALP was -34%, -58% and -61%(p<0.0001).The results support the dose schedule being used in the ongoingALSYMPCA phase III trial of 50 kBq/kg every four weeks for sixcycles, and anticipated to be used in combination studies withdocetaxel expected to begin in the first half of 2010. ###http://hugin.info/134655/R/1342750/321509.pdfThis announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Datum: 22.09.2009 - 09:16 Uhr
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reinforces exciting potential of Algeta'"
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