Cougar Biotechnology Announces Presentation of Positive CB7630 (Abiraterone Acetate) Phase II Data at ASCO 2009 Genitourinary...
February 27 2009 - 8:15AM
Business Wire
Cougar Biotechnology, Inc. (NASDAQ: CGRB) announced that results
from ongoing Phase II clinical trials of Cougar�s investigational
drug CB7630 (abiraterone acetate) were presented at the ASCO
Genitourinary Cancers Symposium that is currently taking place in
Orlando, Florida. The data were presented today in two poster
presentations. These presentations are further detailed below:
Abiraterone Acetate Plus Prednisone in Chemotherapy Na�ve
Castration Resistant Prostate Cancer (CRPC) Patients Not Exposed to
Ketoconazole: Results of a Multicenter Phase II Study Conducted by
the DOD Prostate Cancer Clinical Trial Consortium
A Phase II clinical trial of CB7630 (COU-AA-002) is being
conducted by The Prostate Cancer Clinical Trials Consortium, a
national clinical research group sponsored by the Department of
Defense, with Dr. Charles J. Ryan, Associate Professor of Clinical
Medicine at the University of California, San Francisco
Comprehensive Cancer Center as the principal investigator. In this
Phase II trial, CB7630 in combination with prednisone is
administered once daily to chemotherapy-na�ve, ketoconazole-na�ve
patients with castration resistant prostate cancer (CRPC), who had
progressive disease despite treatment with LHRH analogues and other
hormonal therapies. Twenty-six (79%) of the 33 patients who were
enrolled in the trial had radiological evidence of metastatic
disease with bone metastases, 15 patients (45%) had lymph node
metastases and 2 patients (6%) had visceral metastases.
In his poster presentation, Dr. Ryan presented data on the 31
evaluable patients treated in the trial. Of these patients, 24
(77%) experienced a decline in prostate specific antigen (PSA)
levels of greater than 30%, 22 (71%) experienced a PSA decline of
greater than 50% and 8 (26%) experienced PSA declines of greater
than 90%. For the 31 evaluable patients, the median time to PSA
progression has not yet been reached, with patients continuing to
be treated for 10+ months.
Of the 33 evaluable patients with tumor lesions that were
measurable by the RECIST criteria, treatment with CB7630 resulted
in partial radiological responses in 8 patients (24%), stable
disease in 13 patients (39%) and progressive disease in 4 patients
(12%); 8 patients (24%) are awaiting radiographic disease
assessment.
Identification of an Androgen Withdrawal Responsive Phenotype
in Castrate Resistant Prostate Cancer (CRPC) Patients Treated with
Abiraterone Acetate (COU-AA-BMA)
The COU-AA-BMA clinical trial of CB7630 is being conducted at
The University of Texas M.D. Anderson Cancer Center (MDACC) in
order to investigate associations between serum and
microenvironment (bone marrow) androgen concentrations and response
to CB7630. In this Phase II trial, CB7630 in combination with
prednisone was administered orally, once daily, to patients with
CRPC, who had progressive disease despite treatment with LHRH
analogues and multiple other therapies. All of the 53 patients who
were enrolled in the trial had radiological evidence of metastatic
disease with bone metastases. Forty-two patients (79%) had at least
10 metastatic bone lesions, 7 patients (13%) had visceral
metastases and 15 patients (28%) had lymph node metastases.
Twenty-eight (53%) of the 53 patients had received prior treatment
with ketoconazole and/or diethylstilbesterol and 44 patients (83%)
had received prior treatment with chemotherapy, with 28 patients
(53%) having received two or more prior chemotherapy regimens
before entering the trial.
In her poster presentation, Dr. Eleni Efstathiou from MDACC
presented data on the 50 evaluable patients treated in the trial.
Of the 50 evaluable patients, 24 patients (48%) experienced a
confirmed decline in PSA levels of greater than 50%. In addition, 6
patients (12%) experienced PSA declines of greater than 90%. For
the 50 evaluable patients, the median duration of treatment was 41
weeks (10.3 months). Twenty-five (50%) of the 50 patients
experienced an improvement in performance status.
Of the 21 patients re-evaluated with radiographic imaging
studies after six months of treatment, 4 patients (19%) showed an
improvement in their bone scan and 15 patients (71%) showed a
stable bone scan. Also, 2 (40%) of 5 patients with lymph node
metastases showed a partial radiological response (as measured by
the RECIST criteria) and 3 patients (60%) with lymph node
metastases showed stable disease after six months of treatment with
CB7630. Lastly, 1 of 2 patients with liver metastases demonstrated
a partial radiological response (as measured by the RECIST
criteria).
Both serum and bone marrow testosterone levels were measured
before and after treatment with CB7630. A decline in both serum and
bone marrow testosterone levels to below detectable levels (
Cougar Biotechnology (MM) (NASDAQ:CGRB)
Historical Stock Chart
From Jun 2024 to Jul 2024
Cougar Biotechnology (MM) (NASDAQ:CGRB)
Historical Stock Chart
From Jul 2023 to Jul 2024