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May 21, 2007
Cougar Biotechnology Announces Presentation of Positive CB7630 Clinical Data at AUA Annual Meeting
Interim Phase II Results Confirm Efficacy of CB7630 in Chemotherapy Naïve Castration Resistant Prostate Cancer Patients
Los Angeles, CA, May 21, 2007 - Cougar Biotechnology, Inc. (OTCBB: CGRB) today announced that
positive Phase I and Phase II data on the Company's prostate cancer drug candidate CB7630 (abiraterone
acetate) was presented at the American Urological Association (AUA) Annual Meeting, which is
currently taking place in Anaheim, California. The data was presented by Dr. Timothy A. Yap from the
Cancer Research UK Centre for Cancer Therapeutics at The Institute of Cancer Research in an oral
presentation entitled, “Abiraterone acetate, an inhibitor of androgen synthesis, has significant antitumor
activity in castration resistant prostate cancer.”
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-naïve patients with castration refractory prostate cancer (CRPC), who had
progressive disease despite treatment with LHRH analogues and multiple other hormonal therapies,
including antiandrogens, diethylstilboestrol and dexamethasone. To date a total of 38 patients have been
treated in the Phase I/II trial, including 15 patients treated in the Phase I portion of the trial and 23
patients treated in the Phase II portion of the trial. In his presentation, Dr. Yap reported that in the 38
patients treated in this trial, 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.
In the 30 patients who were evaluable in the Phase I/II trial, 18 patients (60%) experienced a confirmed
decline in prostate specific antigen (PSA) levels of greater than 50%, with 10 of the 30 patients (33%)
experiencing PSA declines of greater than 90%. Six additional patients (20%) experienced a decline in
PSA that was less than 50%. Of the 20 evaluable patients with measurable tumor lesions, treatment with
CB7630 resulted in partial radiological responses (as measured by the RECIST criteria) in 11 patients
(55%), with 7 patients demonstrating ongoing stable disease and 3 patients experienced regressing bone
disease. Individual patients treated with CB7630 also experienced improvement in pain and a reduction
in opioid use.
Currently 19 (63%) of the 30 patients in the Phase I/II trial remain on study and are continuing to be
treated with CB7630. Of the 15 patients in the Phase I portion of the trial, 9 patients (60%) are still
receiving treatment with CB7630, with the average patient having received the drug for over 9.2 months
and with 4 patients having received the drug for over 12 months.
Dr. Arie S. Belldegrun, M.D., FACS, Vice Chairman of the Board of Directors of Cougar Biotechnology,
said, “The clinical data on abiraterone continues to demonstrate strong evidence of the antitumor activity
of the drug in CRPC patients. CB7630 has the potential to be used by both urologists who treat patients
with second line hormonal therapies and by medical oncologists who treat patients in the second line
chemotherapy setting; therefore, we are pleased to be able to present, for the first time, the clinical data on
abiraterone to the urology community.” Alan H. Auerbach, Chief Executive Officer and President of
Cougar Biotechnology, added, "We are pleased to be able to present the clinical data from this CB7630
trial at AUA. We look forward to continuing to provide updates on these ongoing trials at future cancer
conferences and greatly look forward to the continued development of CB7630 in both the second line
hormone therapy and second line chemotherapy settings."
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.
Contact
Alan H. Auerbach
Chief Executive Officer and President
+1 310-943-8040
ahauerbach@cougarbiotechnology.com
Mariann Ohanesian
Director of Investor Relations
+1 310-943-8040, Ext. 117
mohanesian@cougarbiotechnology.com
Russo Partners, LLC
David Schull
+1 212-845-4271
David.Schull@eurorscg.com
Andreas Marathovouniotis
+1 212-845-4253
Andreas.Marathis@eurorscg.com
Forward-Looking Statements:
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 benefits to be derived from Cougar's drug development
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 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.
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Cougar Biotechnology, Inc.
10990 Wilshire Blvd, Suite 1200
Los Angeles, CA 90024
(310) 943-8040 Main
(310) 943-8059 Fax |
