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 2009 ASCO
Annual Meeting that is currently taking place in Orlando, Florida.
The data were released today in three poster presentations. These
presentations are further detailed below:
Preliminary results of a phase II multicenter study of
chemotherapy-na�ve castration-resistant prostate cancer (CRPC)
patients not exposed to ketoconazole, treated with abiraterone
acetate plus prednisone (COU-AA-002)
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.
In his poster discussion presentation, Dr. Ryan presented data
on the 33 evaluable patients treated in the trial. After 12 weeks
of treatment, 26 patients (79%) experienced a decline in prostate
specific antigen (PSA) levels of greater than 30%, 24 (73%)
experienced a PSA decline of greater than 50% and 10 (30%)
experienced PSA declines of greater than 90%. For the 33 evaluable
patients, the median time to PSA progression was 337 days (48
weeks).
Of the 33 evaluable patients, treatment with CB7630 plus
prednisone resulted in radiologic disease control in 28 patients
(85%) with partial responses in 9 patients (27%) and stable disease
in 19 patients (58%).
A multicenter phase II study of abiraterone acetate (AA)
demonstrates anti-tumor activity in docetaxel pre-treated
castration-resistant prostate cancer (CRPC) patients
(COU-AA-003)
The COU-AA-003 Phase II trial of CB7630 in patients with
advanced prostate cancer who have failed docetaxel-based
chemotherapy was conducted at numerous locations 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 therapy and failed treatment with
first-line docetaxel-based chemotherapy.
Dr. Allison Reid from The Institute of Cancer Research and The
Royal Marsden Hospital in the United Kingdom presented data on the
47 patients enrolled in this Phase II trial. CB7630 was well
tolerated with only minimal toxicity in this post-docetaxel
population. After 12 weeks of treatment, of the 47 patients
treated, 24 patients (51%) experienced a decline in PSA of greater
than 30%, with 19 patients (40%) demonstrating a decline in PSA
levels of greater than 50%, and 6 patients (13%) demonstrating a
decline in PSA levels of greater than 90%. Of the 47 evaluable
patients with measurable tumor lesions, radiologic disease control
was observed in 31 of the 47 patients (66%) with 6 patients (13%)
experiencing confirmed partial radiological responses and 25
patients (53%) experiencing stable disease. The median time to PSA
progression for the 47 patients in the trial was estimated to be
169 days (24 weeks).
Phase II multicenter study of abiraterone acetate (AA) plus
prednisone therapy in docetaxel treated castration-resistant
prostate cancer (CRPC) patients: impact of prior ketoconazole
(COU-AA-004)
During his poster discussion presentation, Dr. Daniel Danila
from Memorial Sloan-Kettering Cancer Center presented data from the
ongoing Phase II trial of CB7630 in combination 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 58
patients have been enrolled in the trial at 8 different
centers.
Of the 58 patients, 13 patients (22%) had visceral disease, 26
patients (45%) had bone and soft tissue metastases, 11 patients
(19%) had bone metastases only and 8 patients (14%) had soft tissue
metastases only. Additionally, 27 patients (47%) had been
previously treated with ketoconazole, a drug that is currently used
off-label as a secondary hormonal therapy.
The combination of CB7630 plus prednisone was well tolerated
with only minimal toxicity in this post-docetaxel population. After
12 weeks of treatment, 20 patients (34%) experienced a confirmed
decline in PSA levels of greater than 50%. Of the 31 patients who
had not received prior treatment with ketoconazole, 13 patients
(42%) experienced a confirmed decline in PSA levels of greater than
50%. Furthermore, of the 27 patients who had been previously
treated with ketoconazole, 7 patients (26%) experienced a confirmed
decline in PSA levels of greater than 50%.
Of the 18 evaluable patients with measurable tumor lesions, 3
patients (17%) experienced confirmed partial radiological responses
(as measured by the RECIST criteria) and 11 patients (61%)
experienced ongoing stable disease. For the 31 patients who had not
received prior treatment with ketoconazole, the median time to PSA
progression was estimated to be 198 days (28 weeks). Furthermore,
for the 27 patients who had been previously treated with
ketoconazole, the median time to PSA progression was estimated to
be 99 days (14 weeks).
Alan H. Auerbach, Chief Executive Officer and President of
Cougar Biotechnology, said, "We are pleased to present data from
these clinical trials at the ASCO Annual Meeting. CB7630 continues
to show strong evidence of antitumor activity in patients with
chemotherapy-na�ve disease as well as in patients with
chemotherapy-refractory disease. These populations not only
represent significant unmet medical needs in prostate cancer but
also are representative of the patient populations being studied in
our ongoing Phase III trials (COU-AA-301 and COU-AA-302)."
Arturo Molina, M.D., M.S., FACP, Chief Medical Officer and
Executive Vice President of Clinical Research and Development of
Cougar, added, "We are pleased to present the multi-center results
of these Phase II studies, which continue to support the potential
roles of CB7630 both as a second-line hormonal therapy for patients
with advanced prostate cancer who fail first-line hormonal
treatment and as a second-line therapy for patients with advanced
prostate cancer who fail docetaxel-based chemotherapy. These
patient groups continue to represent patient populations that are
underserved with current treatments."
About Cougar Biotechnology, Inc.
Cougar Biotechnology, Inc. is a Los Angeles-based biotechnology
company established to in-license and develop clinical stage drugs,
with a specific focus on the field of oncology. Cougar�s oncology
portfolio includes CB7630, a targeted inhibitor of the 17-alpha
hydroxylase/c17,20 lyase enzyme, which is currently being studied
in two Phase III clinical trials in prostate cancer and a Phase
I/II trial in breast 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 a number of solid tumor types.
Further information about Cougar can be found at
www.cougarbiotechnology.com.
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. These statements are often, but not always, made through the
use of words or phrases such as ``anticipates,'' ``expects,''
``plans,'' ``believes,'' ``intends,'' and similar words or phrases.
These forward-looking statements include, without limitation,
statements related to the potential advantages of CB7630 and its
potential for use in the treatment of advanced prostate cancer.
Such statements involve risks and uncertainties that could cause
Cougar�s actual results to differ materially from the anticipated
results and expectations expressed in these forward-looking
statements. These statements are only predictions based on current
information and expectations and involve a number of risks and
uncertainties. Actual events or results may differ materially from
those projected in any of such statements due to various factors,
including the risks and uncertainties inherent in clinical trials,
and drug development and commercialization. For a discussion of
these and other factors, please refer to Cougar�s annual report on
Form 10-K for the year ended December 31, 2008, as well as other
subsequent filings with the Securities and Exchange Commission. You
are cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date hereof. This caution is
made under the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. All forward-looking statements are
qualified in their entirety by this cautionary statement and Cougar
undertakes no obligation to revise or update this press release to
reflect events or circumstances after the date hereof.
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