27th Feb 2008 07:02
AstraZeneca PLC27 February 2008 AstraZeneca Provides Update On RECENTIN(TM) Clinical Development Programme HORIZON Colorectal Cancer Programme Continues Into Phase III; BR24 Non-Small Cell Lung Cancer Trial Will Not Progress AstraZeneca today announced that its HORIZON III Phase II/III head-to-head studyof RECENTIN(TM) (cediranib, AZD2171) with chemotherapy versus bevacizumab (Avastin(TM)) with chemotherapy in patients with first line metastaticcolorectal cancer (CRC) will be progressing directly into Phase III at 20mg. Patients will also continue to be recruited at 20mg into the first line CRCHORIZON II study of RECENTIN with chemotherapy versus chemotherapy alone. The HORIZON Independent Data Monitoring Committee (IDMC) conducted a planned endof Phase II (EOP II) review of efficacy and tolerability data from HORIZON I,HORIZON II and HORIZON III. Data from HORIZON I, in second line colorectalcancer, would not by itself have contributed to a positive EOP II decision.However, when combined with a review of data from HORIZON II and III by theIDMC, the IDMC confirmed the HORIZON programme in 1st line CRC could continueand HORIZON II and III had met pre-defined EOP II criteria. AstraZeneca today also announced that the National Cancer Institute of CanadaClinical Trials Group (NCIC-CTG) has informed AstraZeneca that the BR24 Phase II/III study of RECENTIN at 30mg in first line non-small cell lung cancer (NSCLC)will not continue into Phase III following the planned end of Phase II efficacyand tolerability analysis by the study's Data Safety Monitoring Committee.Although evidence of clinical activity was seen, there appeared to be animbalance in toxicity and therefore the study was considered not to have met thepre-defined criteria for automatic continuation into Phase III. AstraZeneca is working in close collaboration with the NCIC-CTG to understandthe BR24 data further. In addition to colorectal and non-small cell lung cancer, the RECENTINdevelopment programme includes trials in recurrent glioblastoma and a number ofsignal search studies in other tumours. John Patterson, AstraZeneca's Executive Director for Development, said: "Giventhere is such a high unmet patient need for more effective treatments in cancer,we are pleased that the HORIZON colorectal cancer programme has met itspre-defined criteria to continue recruitment into Phase III. Due to the Phase II/III trial design, HORIZON III is able to move directly into Phase III utilisingall the Phase II data and this saves valuable time in assessing the potentialbenefit of RECENTIN in the first line metastatic colorectal cancer setting. "AstraZeneca supports the NCIC-CTG's BR24 recommendation and is working withthem to understand the data more fully in NSCLC. As evidence of clinicalactivity was seen in BR24, AstraZenenca remains committed to investigating thepotential of RECENTIN in lung cancer and reducing the incidence of seriousadverse events." RECENTIN(TM) is a trademark of the AstraZeneca group of companies. 27th February 2008 Notes To Editors: About the National Cancer Institute of Canada Clinical Trials Group The National Cancer Institute of Canada Clinical Trials Group (NCIC-CTG), fundedby the Canadian Cancer Society and based at Queen's University in Kingston,Ontario, Canada, develops, conducts and analyses national and internationaltrials of cancer therapy, including trials for new cancer drugs, cancerprevention and supportive care to improve quality of life for people withcancer. Since its inception in 1971, the NCIC-CTG has enrolled more than 40,000patients from Canada and around the world in over 300 clinical trials. BR24 Background NSCLC accounts for approximately 80 percent of all cases of lung cancer. Lungcancer is the most common cancer in the world with 1.3 million new casesdiagnosed every year and nearly 1.2 million people dying as a result of thedisease annually. BR24 is a collaboration between AstraZeneca and the NCIC-CTG, based at Queen'sUniversity in Kingston, Ontario. The study is a randomised, double-blind,placebo-controlled Phase II/III investigation of RECENTIN plus paclitaxel andcarboplatin versus the chemotherapy arm alone. In the Phase II part of thestudy, patients were recruited from countries including: Argentina, Australia,Brazil, Canada, Romania and Singapore. RECENTIN and Colorectal Cancer Colorectal cancer is the third most commonly reported cancer worldwide, witharound 945,000 new cases and 492,000 deaths annually. The Horizon Study Programme is evaluating RECENTIN in patients with first lineadvanced colorectal cancer: Study Phase Design PopulationHorizon III II/III Double blind, randomised trial of cediranib in Patients with first line combination with FOLFOX compared to bevacizumab in metastatic colorectal combination with FOLFOX cancerHorizon II III Double blind, randomised trial of cediranib plus Patients with first line standard chemotherapy compared to standard metastatic colorectal chemotherapy alone cancerHorizon I II Double blind, randomised trial of cediranib in Patients with second line combination with FOLFOX compared to bevacizumab in metastatic colorectal combination with FOLFOX cancer RECENTIN: a potent and selective VEGF signalling inhibitor RECENTIN is a once-daily, orally available, highly potent and selective VEGFsignalling inhibitor that inhibits all three VEGF receptors. VEGF signalling is a key driver of angiogenesis - the formation of new bloodvessels that tumours need to grow and spread. RECENTIN inhibits this signal bybinding to the intracellular domain of all three VEGF receptors, in particularVEGFR-2, the predominant receptor through which VEGF exerts its effects onangiogenesis, preventing the growth of new blood vessels. This effectively "starves" the tumour of the oxygen and nutrients it needs to grow. Phase I data indicate that RECENTIN is generally well tolerated, with the mostcommon adverse events being diarrhoea, fatigue, hoarseness, nausea, vomiting,headache, hypertension and hand foot syndrome. About AstraZeneca AstraZeneca is a major international healthcare business engaged in research,development, manufacturing and marketing of prescription pharmaceuticals andsupplier for healthcare services. AstraZeneca is one of the world's leadingpharmaceutical companies with healthcare sales of US $29.55 billion and is aleader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncologyand infection product sales. AstraZeneca is listed in the Dow JonesSustainability Index (Global) as well as the FTSE4Good Index. For further information: Media Enquiries: Neil McCrae, +44 207 304 5045 (24 hours) Steve Brown, +44 207 304 5033 (24 hours) Chris Sampson, +44 207 304 5130 (24 hours) Investor Enquiries: Jonathan Hunt, +44 207 304 5087 Ed Seage, +1 302 886 4065 Karl Hard, +44 207 304 5322 Jorgen Winroth, +1 212 579 0506 Mina Blair, +44 20 7304 5084 Peter Vozzo, (MedImmune) +1 301 398 4358 - ends - This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
Astrazeneca