Exhibit 99.1
Cougar Biotechnology Presents Positive CB7630 Phase II Data at
Prostate Cancer Foundation Scientific Retreat
Interim Phase II Results Confirm Efficacy of CB7630 in Both
Chemotherapy Naive and Chemotherapy Refractory Prostate Cancer
Patients
LOS ANGELES--(BUSINESS WIRE)--Oct. 12, 2007--Cougar Biotechnology,
Inc. (OTCBB: CGRB) today announced that results from ongoing Phase I
and Phase II clinical trials of Cougar's investigational drug CB7630
(abiraterone acetate) were presented at the Prostate Cancer Foundation
Scientific Retreat on October 11th. The Prostate Cancer Foundation
Scientific Retreat is currently taking place in Lake Tahoe, Nevada.
During his oral presentation entitled "Inhibitors of Androgen
Metabolism: Abiraterone," Dr. Johann S. DeBono from The Institute of
Cancer Research and The Royal Marsden NHS Foundation Trust in the
United Kingdom presented data from two ongoing clinical trials of
CB7630. These trials include a Phase I/II trial of CB7630 in patients
with hormone refractory, chemotherapy naive, prostate cancer
(COU-AA-001) and a Phase II trial of CB7630 in patients with advanced
prostate cancer who have failed androgen deprivation and
docetaxel-based chemotherapy (COU-AA-003). The data from these
respective trials are further detailed below.
Phase I/II Trial of CB7630 (Abiraterone Acetate) in Patients with
Hormone Refractory, Chemotherapy Naive, Prostate Cancer (COU-AA-001)
The Phase I/II trial of CB7630 was conducted at The Institute of
Cancer Research and at The Royal Marsden NHS Foundation Trust in the
United Kingdom. In the trial, CB7630 was administered orally, once
daily, to chemotherapy-naive patients with castration resistant
prostate cancer (CRPC), who had progressive disease despite treatment
with LHRH analogues and multiple other hormonal therapies. To date, a
total of 52 patients have been treated in the Phase I/II trial,
including 18 patients treated in the Phase I portion of the trial and
34 patients treated in the Phase II portion of the trial. Of the 44
patients who were evaluable, all of the patients had radiological
evidence of metastatic disease with 31 patients (70%) having evidence
of bone metastases and 21 patients (48%) having measurable disease as
per the RECIST criteria. Moreover, all of the patients had previously
failed treatment with LHRH analogs and antiandrogens, while 22
patients (50%) had failed treatment with diethylstilboestrol and 20
patients (45%) had failed treatment with steroids.
During his oral presentation, Dr. DeBono reported that CB7630 was
well tolerated at doses as high as 2000 mg/day with minimal toxicity.
Moreover, no dose limiting toxicity has been observed in the trial to
date.
Of the 44 evaluable patients from the Phase I/II trial, 27
patients (61%) experienced a confirmed decline in prostate specific
antigen (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 stable
disease and 3 patients experiencing regressing bone disease on
imaging. Individual patients treated with CB7630 also experienced
improvement in pain and a reduction in opioid use. For the 44
evaluable patients in the trial, the median time to PSA progression
was estimated to be 252 days (8.4 months).
A Phase II Open Label Study of CB7630 (Abiraterone Acetate) in
Patients with Advanced Prostate Cancer Who Have Failed Androgen
Deprivation and Docetaxel-Based Chemotherapy (COU-AA-003)
The Phase II trial of CB7630 in patients with advanced prostate
cancer who have failed docetaxel-based chemotherapy is being conducted
at numerous locations in the United States and United Kingdom. In the
trial, CB7630 is administered orally, once daily, to patients with
castration resistant prostate cancer who have failed treatment with
androgen deprivation therapy and failed treatment with first line
docetaxel-based chemotherapy. To date, a total of 44 patients have
been enrolled in the trial.
In his oral presentation, Dr. DeBono provided an update on the 28
patients in this Phase II trial who have been treated in the United
Kingdom and have been in the study for over 3 months. All of the 28
patients had failed treatment with LHRH analogs and antiandrogens, 20
patients (71%) had failed treatment with steroids and 14 patients
(50%) had failed treatment with diethylstilboestrol. Moreover, all of
the patients in the study had failed treatment with docetaxel and 10
patients (36%) had failed treatment with an additional cytotoxic agent
(mitoxantrone, estramustine, vinorelbine, cyclophosphamide).
Of the 28 patients who have been treated in the Phase II trial,
CB7630 was well tolerated with only minimal toxicity in this
post-docetaxel population. Of the 28 patients treated, 14 patients
(50%) experienced a confirmed decline in PSA levels of greater than
50% and 5 patients (18%) experienced PSA declines of greater than 90%.
Of the 18 evaluable patients with measurable tumor lesions, 4 patients
(22%) experienced confirmed partial radiological responses (as
measured by the RECIST criteria) and 9 patients experienced ongoing
stable disease. Individual patients treated with CB7630 also
experienced improvement in pain and a reduction in opioid use. For the
28 evaluable patients in the trial, the median time to progression was
estimated to be 167 days (23.9 weeks).
Dr. Arie S. Belldegrun, M.D., FACS, Vice Chairman of the Board of
Directors of Cougar Biotechnology, said, "We are pleased to have the
opportunity to present clinical data on CB7630 at a prominent meeting
like the Prostate Cancer Foundation Scientific Retreat and view it as
an important opportunity to build awareness of the drug prior to the
advancement of the clinical development of CB7630 into Phase III
trials, which are currently scheduled for next year. We look forward
to continuing our relationship with the Prostate Cancer Foundation
throughout the course of the clinical development of CB7630." Alan H.
Auerbach, Chief Executive Officer and President of Cougar
Biotechnology, added, "The data from both trials of CB7630 presented
at the Prostate Cancer Foundation Scientific Retreat continues to
support the potential role of the drug in the treatment of CRPC. We
continue to be pleased with the strong evidence of antitumor activity
in patients who were both chemotherapy naive and chemotherapy
refractory, both of which represent significant unmet medical needs in
prostate cancer. We continue to have strong confidence in the
potential of CB7630 in both of these patient populations."
About Cougar Biotechnology
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 tested in
Phase II clinical trials in prostate cancer; CB3304, an inhibitor of
microtubule dynamics, which is currently in a Phase I trial in
hematological malignancies and CB1089, an analog of vitamin D, which
has been clinically tested in a number of solid tumor types.
Further information about Cougar Biotechnology 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
timing of potential clinical trial initiations, benefits to be derived
from Cougar's drug development programs, including the potential
advantages of CB7630, its potential for use in the treatment of CRPC
and in second line hormone and chemotherapy treatment settings. 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, including the uncertainty of whether results in
testing of CB7630 will be predictive of results in later stages of
development. For a discussion of these and other factors, please refer
to Cougar's annual report on Form 10-KSB for the year ended December
31, 2006 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.
CONTACT: Cougar Biotechnology, Inc.
+1-310-943-8040
Alan H. Auerbach, Chief Executive Officer and President
ahauerbach@cougarbiotechnology.com
Mariann Ohanesian, Director of Investor Relations
mohanesian@cougarbiotechnology.com
or
Russo Partners, LLC
David Schull, +1-212-845-4271
David.schull@russopartnersllc.com
Andreas Marathovouniotis, +1-212-845-4253
Andreas.marathis@russopartnersllc.com