27th Feb 2007 09:40
BTG PLC27 February 2007 BTG licensee Cougar Biotechnology presents positive data on prostate cancer compound at ASCO symposium London, UK 27 February 2007: BTG plc (LSE: BGC), the medical innovationscompany, today announces that Cougar Biotechnology, Inc., BTG's licensee forabiraterone acetate (CB7630), has presented positive phase I and phase II dataon the compound at an American Society of Clinical Oncology ("ASCO") prostatecancer symposium in Orlando, FL on 23 February 2007. An extract from Cougar's announcement follows: Cougar Biotechnology Announces Presentation of Positive Phase I and Phase II Data at ASCO Prostate Cancer Symposium Interim Phase II Data Confirms Previous Phase I Results and Demonstrates Activity in Patients Refractory to Taxotere; Additional Interim Phase I Data Shows Evidence of Antitumor Activity in Patients Refractory to Treatment with Ketoconazole Los Angeles, CA, February 23, 2007 - Cougar Biotechnology, Inc. (OTCBB:CGRB.OB) today announced that positive Phase I and Phase II data on theCompany's prostate cancer drug candidate CB7630 (abiraterone acetate) waspresented today at the American Society of Clinical Oncology (ASCO) ProstateCancer Symposium that is currently taking place in Orlando FL. The data waspresented in various formats including poster presentation and oralpresentation. These presentations are further detailed below: Phase I/II Trial of CB7630 (Abiraterone Acetate) in Patients with HormoneRefractory, Chemotherapy Naive, Prostate Cancer The Phase I/II trial of CB7630 was conducted at The Institute of Cancer Researchand at The Royal Marsden NHS Foundation Trust in the United Kingdom. In thetrial, CB7630 was administered once daily to chemotherapy-naive patients withcastration refractory prostate cancer (CRPC), who had progressive diseasedespite treatment with LHRH analogues and multiple other hormonal therapiesincluding antiandrogens, diethylstilboestrol and dexamethasone. The results fromthe completed Phase I stage of the trial were presented during today's postersession and showed that in the 15 patients tested, CB7630 was well tolerated atdoses as high as 2000 mg/day with no dose limiting toxicity being observed. Ofthe 15 patients that were evaluable for antitumor activity, 9 patients (60%)experienced a confirmed decline in prostate specific antigen (PSA) levels ofgreater than 50% with 6 of the 15 patients (40%) experiencing PSA declines ofgreater than 90%. Of the 10 evaluable patients with measurable tumor lesions,treatment with CB7630 resulted in partial radiological responses (as measured bythe RECIST criteria) in 5 (50%) patients, while 2 patients experiencedregressing bone disease and 3 other patients have ongoing stable disease.Individual patients treated with CB7630 also experienced improvement in pain.Circulating tumor cells (CTC) were detected in 6 of 14 patients and changes inCTC counts were shown to correlate with changes in PSA. The results of the Phase I portion of the trial as well as the interim resultsfrom the ongoing Phase II portion of the trial were further discussed during anoral presentation given this afternoon by Dr. Johann DeBono, the principalinvestigator in the trial, from The Institute of Cancer Research and The RoyalMarsden NHS Foundation Trust in the United Kingdom. During his presentation entitled "What are the Best Targets for InvestigationalTherapy?", Dr. DeBono stated that 18 (60%) out of 30 patients (including the 15patients in the Phase I portion of the trial described above and 15 patientstreated thus far in the Phase II expansion) experienced a decline in PSA levelsof greater than 50%. Dr. DeBono also stated that 9 (60%) of the 15 patients fromthe Phase I portion of the trial are continuing on treatment with CB7630 forover 6 months, with some patients on the drug for over 12 months. A Phase II Open Label Study of CB7630 (Abiraterone Acetate) in Patients withAdvanced Prostate Cancer Who Have Failed Androgen Deprivation andDocetaxel-Based Chemotherapy The Phase II trial is being conducted at numerous locations in the United Statesand United Kingdom. In the trial, CB7630 is administered once daily to patientswith hormone refractory prostate cancer that have failed treatment withdocetaxel chemotherapy. During his oral presentation entitled "What are the BestTargets for Investigational Therapy?" Dr. Johann DeBono, who is an investigatorin the trial, from The Institute of Cancer Research and The Royal Marsden NHSFoundation Trust in the United Kingdom presented the interim results from thepatients in the trial treated at his center. More specifically, Dr. DeBonostated that a 50% drop in PSA has been detected in 7 (54%) of the first 13patients that have been treated with CB7630 in the trial. Individual patientstreated with CB7630 have also experienced symptomatic relief of pain anddecreased analgesic use. Phase I Evaluation of Abiraterone Acetate (CB7630), a 17 Alpha HydroxylaseC17,20-Lyase Inhibitor in Androgen Independent Prostate Cancer (AiPCa) The Phase I trial was conducted at the University of California, San FranciscoComprehensive Cancer Center with Charles J. Ryan, MD, Assistant ClinicalProfessor of Medicine, as the principal investigator. CB7630 was administeredonce daily to chemotherapy-naive patients with hormone refractory prostatecancer (HRPC), who had progressive disease despite treatment with LHRH analoguesand multiple other hormonal therapies. The interim results from the Phase Itrial were published in the 2007 Prostate Cancer Symposium Program/ProceedingsBook. Of the 9 patients that had been enrolled in the study, 2 patients had "PSA only"disease and 7 patients had bone metastases. 8 of 9 patients had received priortreatment with ketoconazole. Treatment with CB7630 was found to be welltolerated at doses up to 500 mg/day and no dose limiting toxicity has beenobserved in the trial to date. Of the 6 patients who had completed the initial28 day treatment cycle, 6 (100%) have experienced a decline in PSA and 5 of 6patients (83%) have experienced a >50% decline in PSA. Dr. Arie S. Belldegrun, MD, FACS, Vice Chairman of the Board of Directors ofCougar Biotechnology, said, "The body of data on CB7630 presented at the ASCOProstate Cancer Symposium is important for several reasons. First, not only doesit confirm the earlier signal of clinical activity in second line hormonaltherapy patients, but it also demonstrates that CB7630 is active in patientsthat have failed ketoconazole, a drug that is currently widely used off-label asa secondary hormonal therapy. Second, this data for the first time demonstratesthat CB7630 appears to be active as a second line chemotherapy in patients whohave failed docetaxel-based chemotherapy. As both populations of patients(second line hormone therapy candidates and second line chemotherapy candidates)continue to represent significant unmet medical needs in HRPC, we believe thatCB7630 has strong potential in both of these patient populations." Alan H. Auerbach, Chief Executive Officer and President of Cougar Biotechnology,added, "We continue to be pleased with the clinical data being generated onCB7630. We greatly look forward to the continued development of CB7630 in boththe second line hormone therapy and second line chemotherapy settings." For further information contact: BTG Financial DynamicsAndy Burrows, Director of Investor Relations Ben Atwell/Anna Keeble+44 (0)20 7575 1741; mobile: +44 (0)7990 530605 +44 (0)20 7831 3113Christine Soden, Chief Financial Officer+44 (0)20 7575 1591 About BTG BTG in-licenses, develops and commercialises pharmaceuticals and other medicaltechnologies. With a substantial and growing revenue stream of royalties andmilestone payments from out-licensed products, BTG continues to strengthen itspipeline of preclinical and clinical development programmes. Active in thefields of oncology, diseases of ageing, neuroscience, drug repositioning andmedical devices, BTG works from its offices in London, Philadelphia and Osakawith a global partner network of healthcare companies and researchorganisations. For further information, visit: www.btgplc.com. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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