Cougar Biotechnology, Inc. (NASDAQ:CGRB) announced that grades from ongoing Phase I and Phase II clinical suffering of Cougar's investigational medication, CB7630 (abiraterone acetate), be presented at the ASCO Genitourinary Cancers Symposium that be in a minute taking bunch in San Francisco, California. The facts be presented today in both an oral upgrading and two discern presentation. These presentations be further detailed down below: Predictors of Response and Pharmacodynamic Endpoints in a Phase I and Pharmacokinetic Study of Abiraterone Acetate in Castration Resistant Prostate Cancer (COU-AA-001) The dose range Phase I trial of CB7630 was conduct at The Institute of Cancer Research and at The Royal Marsden NHS Foundation Trust in the United Kingdom. In the trial, CB7630 was administered out loud, once day after day, to chemotherapy-na�ve patients subsequent to castration rainproof prostate cancer (CRPC), who have free-thinking virus in maliciousness of behaviour with LHRH analogues and multiple other hormonal therapy. In his poster presentation, Dr. Gerhardt Attard from The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust presented data on top of the 21 patients treat in the Phase I quota of the trial (COU-AA-001). CB7630 was stalwartly present good opinion of at dose by means of means of illustrious as 2000 mg/day with minimal toxicity. Moreover, no dose limiting toxicity have be observed in the trial to date.
Of the 21 evaluable patients from the Phase I portion of the trial, 12 patients (57%) fully grown a confirmed decline in prostate specific antigen (PSA) height of greater than 50% and 6 patients (29%) experienced PSA decline of greater than 90%. Of the 8 evaluable patients with measurable tumor lesion, treatment with CB7630 resulted in partial radiological comeback (as measured by the RECIST criteria) in 5 patients (63%) and 2 patients experienced regress prepare disease on imaging. Also, of the 11 patients in the trial with suggestive backache, 8 patients (73%) experienced an innovation in symptomatic pain mutually with reduction in opioid utilization.
Tumor tissue was obtain from 18 of the 21 patients in the Phase I trial in send to question tabloid in help of the attendance of the TMPRSS2-ERG fusion gene, which has been identified in a measure of patients with prostate cancer (Science, 2005 Oct 28;310(5748):644-8) and may embody an androgen regulated gene fusion. Of the 18 patients from whom tissue was obtained, 6 patients were found to personal an ERG gene rearrangement and 5 (83%) of these 6 patients experienced a confirmed decline in PSA levels of greater than 50%.
Selective CYP17 Inhibition with Abiraterone Acetate Results in a High Response Rate in Castration Resistant Prostate Cancer (CRPC), Confirming the Continued Importance of Targeting Androgen Receptor Signaling (COU-AA-001 and COU-AA-003) During her poster presentation, Dr. Alison Reid from The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust in the United Kingdom presented data from two ongoing Phase II clinical trials of CB7630. These trials involve a Phase II trial of CB7630 in patients with hormone refractory, chemotherapy na�ve, prostate cancer (COU-AA-001) and a Phase II trial of CB7630 in patients with advanced prostate cancer who have bungled androgen deprivation and docetaxel-based chemotherapy (COU-AA-003).
In the COU-AA-001 trial, CB7630 was administered orally, once daily, to chemotherapy-na�ve patients with CRPC, who had progressive disease despite treatment with LHRH analogues and multiple other hormonal therapies. Of the 44 patients who were evaluable in the Phase II portion of the trial, all of the patients had radiological testimony of metastatic disease, with 31 patients (70%) have evidence of bone metastases and 21 patients (48%) having measurable disease as per the RECIST benchmark.
Of the 44 evaluable patients from the Phase II trial, 27 patients (61%) experienced a confirmed decline in PSA levels of greater than 50% and 11 patients (25%) experienced PSA declines of greater than 90%. Of the 21 evaluable patients with measurable tumor lesions, treatment with CB7630 resulted in partial radiological responses (as measured by the RECIST criteria) in 12 patients (57%), with 7 patients demonstrating ongoing sound disease and 3 patients experiencing regressing bone disease on imaging. Individual patients treated with CB7630 also experienced improvement anguished and a decline in opioid use. For the 44 evaluable patients in the trial, the median occurrence to PSA improvement was rough to be 252 days (8.4 months).
The COU-AA-003 Phase II trial of CB7630 in patients with advanced prostate cancer who have failed docetaxel-based chemotherapy is man conducted at numerous position in the United States and United Kingdom. In the trial, CB7630 is administered orally, once daily, to patients with CRPC who have failed treatment with androgen deprivation treatment and failed treatment with best moment ancient vein docetaxel-based chemotherapy. To date, a packed of 44 patients have been enrol in the trial.
In her poster presentation, Dr. Reid afford an update on the 31 patients here Phase II trial who have been treated in the United Kingdom and have been in the search for complete 3 months.
Of the 31 patients who were evaluable in the Phase II portion of the trial, all of the patients had radiological evidence of metastatic disease, with 25 patients (81%) having evidence of bone metastases and 18 patients (58%) having measurable disease as per the RECIST criteria.
Of the 31 patients who have been treated in the Phase II trial, CB7630 was well tolerated with simply minimal toxicity in this post-docetaxel population. Of the 31 patients treated, 15 patients (48%) experienced a confirmed decline in PSA levels of greater than 50% and 6 patients (19%) experienced PSA declines of greater than 90%. Of the 19 evaluable patients with measurable tumor lesions, 5 patients (26%) experienced confirmed partial radiological responses (as measured by the RECIST criteria) and 10 patients (53%) experienced ongoing stable disease.
Preliminary Phase II Results of Abiraterone Acetate in Patients with Castration Resistant Metastatic Prostate Cancer After Failure of Docetaxel-Based Chemotherapy (COU-AA-004) During his oral presentation, Dr. Daniel Danila from Memorial Sloan-Kettering Cancer Center presented data from the ongoing Phase II trial of CB7630 in variety with prednisone in patients with advanced prostate cancer who have failed androgen deprivation and docetaxel-based chemotherapy (COU-AA-004).
The COU-AA-004 Phase II trial is being conducted at numerous locations in the United States and United Kingdom. In the trial, CB7630 in combination with prednisone is administered orally, once daily, to patients with CRPC who have failed treatment with androgen deprivation therapy and have failed treatment with first line docetaxel-based chemotherapy. To date, a total of 54 patients have been enrolled in the trial.
In his oral presentation, Dr. Danila provided an update on the 38 patients in this Phase II trial who have been treated at Memorial Sloan-Kettering Cancer Center. Of the 38 patients who have been treated in the Phase II trial, CB7630 was well tolerated with only minimal toxicity in this post-docetaxel population. No patients automated hypertension of any position associated to treatment with CB7630 while enrolled in the trial. Of the 38 patients who were evaluable, 10 patients (26%) had visceral disease, 16 patients (43%) had bone and fleshy tissue metastases, 10 patients (26%) had bone metastases only and 2 patients (5%) had squashy tissue metastases only.
Of the 38 evaluable patients, 17 patients (45%) experienced a confirmed decline in PSA levels of greater than 50%. Of the 21 evaluable patients who had not received prior treatment with ketoconazole, a drug explicitly currently widely before owned off-label as a poor quality hormonal therapy, 12 patients (57%) experienced a confirmed decline in PSA levels of greater than 50%.
Furthermore of the 17 evaluable patients who had been previously treated with ketoconazole, 5 patients (29%) experienced a confirmed decline in PSA levels of greater than 50%.
Of the 24 patients with lesions that were evaluable by bone scan, 16 patients had lesions that were unaltered according to the PSA Working Group (PSWG2) Consensus. Of the 16 patients in the trial with evidence of lymph node metastases that were evaluable by CT scan, 1 forgiving was shown to have lesions that allay in vastness and 9 patients had lesions that were unchanged according to the PSWG2 Consensus. Of the 6 patients in the trial with visceral disease that was evaluable radiologically, 3 patients had lesions that were unchanged according to the PSWG2 Consensus. There are currently 13 patients in the Phase II trial who are continuing to receive treatment with CB7630 in combination with prednisone. Nine of these patients have been on study for over 25 weeks and 4 patients have been on study for concerning 13 and 24 weeks.
Dr. Arie S. Belldegrun, M.D., FACS, Vice Chairman of the Board of Directors of Cougar Biotechnology, said, "We are over the moon to have the opportunity to bequest clinical data on CB7630 at a prominent tryst related to the ASCO Genitourinary Cancers Symposium and we display it as an historic opportunity to concoct perception of the drug prior to introduction of the CB7630 Phase III trials that are currently planned to inaugurate in the first partially of this year." Alan H. Auerbach, Chief Executive Officer and President of Cougar Biotechnology, added, "The data from both trials of CB7630 presented at the ASCO Genitourinary Cancers Symposium last to support the eventual role of the drug in the treatment of CRPC. We continue to be pleased with the discordant evidence of antitumor purr in patients who were both chemotherapy na�ve and chemotherapy refractory, both of which represent decisive unmet medical requests in prostate cancer. We have strong sincerity in the potential of CB7630 in both of these patient populations." About Cougar Biotechnology Cougar Biotechnology, Inc. is a Los Angeles-based biotechnology enterprise developed to in-license and heave your sock up clinical chapter drugs, with a specific focus on the pen of oncology. Cougar's oncology portfolio include CB7630, a targeted inhibitor of the 17-alpha hydroxylase/c17,20 lyase enzyme, which is currently being tested in Phase II clinical trials in prostate cancer; CB3304, an inhibitor of microtubule dynamics, which is currently in a Phase I trial in multiple myeloma; and CB1089, an analog of vitamin D, which has been clinically tested in different dense tumor caste.
This pinch secretion contain forward-looking authentication within the purpose of the Private Securities Litigation Reform Act of 1995. These statements are typically, but not always, made through the use of lines or turn of phrase such as ``anticipates,'' ``expect,'' ``devices,'' ``pilfer as reality,'' ``intend,'' and similar words or phrases. These forward-looking statements include, lacking curbing, statements related to the time of clinical trial initiation and the appointed benefits to be derived from Cougar's drug initiation programs, including the potential advantages of CB7630 and its potential for use in the treatment of CRPC and in second line hormone and chemotherapy treatment environment. Such statements trap risk and uncertainties that could incentive Cougar's actual results to hostilities materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are only prediction bed on extant hearsay and expectations and involve a numeral of risks and uncertainties. Actual measures or results may differ materially from those projected in any of such statements in the red to various factor, including the risks and uncertainties ingrained in clinical trials, and drug development and commercialization, including the delay of whether results in carrying out tests of CB7630 will be predictive of results in next stage of development.
For a discussion of these and other factors, gratify refer to Cougar's annual anecdote on Form 10-KSB for the year completed December 31, 2006 moreover as other subsequent filings with the Securities and Exchange Commission. You are caution not to place undue confidence on these forward-looking statements, which verbalize only since the date hereof. This wariness is made underneath the locked harbor implements of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their whole by this threatening statement and Cougar undertake no constraint to alter or update this press release to follow events or position after the date hereof.
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