October
25, 2007
Cougar
Biotechnology Announces Presentation of Positive CB7630
Clinical Data at AACR-NCI-EORTC International Conference on Molecular
Targets and Cancer Therapeutics
Phase
I Results Support the Safety and Efficacy of CB7630 When Taken
With or Without Food in Castration Resistant Prostate Cancer Patients
Los
Angeles, CA, October 25, 2007 Cougar Biotechnology, Inc. (OTCBB:
CGRB) today announced that positive Phase I data on the Company's
prostate cancer drug candidate CB7630 (abiraterone acetate) was
presented at the AACR-NCI-EORTC International Conference on Molecular
Targets and Cancer Therapeutics, which is currently taking place
in San Francisco, California. The data was presented today in
a poster presentation as part of the poster session on hormonal
therapy. The poster presentation is further detailed below:
Effect
of concomitant food intake on pharmacokinetics of abiraterone
acetate, a 17-alpha hydroxylase/C17,20-lyase inhibitor in androgen
independent prostate cancer (AIPC).
The
Phase I dose ranging trial was conducted at the University of
California, San Francisco Comprehensive Cancer Center with Charles
J. Ryan, M.D., Assistant Clinical Professor of Medicine, as the
principal investigator. CB7630 was administered 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."
Of
the 27 patients who were enrolled in the study, 18 patients were
administered CB7630 on an empty stomach while 9 patients received
CB7630 on a full stomach (with a high fat calorie meal). Seventeen
of 27 patients (63%) had received prior treatment with ketoconazole,
a drug that is currently widely used off-label as a secondary
hormonal therapy. Treatment with CB7630 was found to be well tolerated
in both the fasted and fed groups. The safety profile of the drug
was seen to be unaffected by administration of the drug with food.
Overall, in the 27 patients who were treated with CB7630 in both
the fasted and fed groups, 16 of 27 patients (59%) experienced
a greater than 50% decline in prostate specific antigen (PSA)
levels. Furthermore, 11 of the 18 patients (61%) in the fasted
group and 5 of the 9 patients (56%) in the fed group experienced
a greater than 50% decline in PSA levels."
Dr.
Arie S. Belldegrun, M.D., FACS, Vice Chairman of the Board of
Directors of Cougar Biotechnology, said, "We are pleased
to be able to demonstrate not only that CB7630 is active in patients
who have failed ketoconazole, but also that the safety profile
of the drug is not affected by food intake.” Alan H. Auerbach,
Chief Executive Officer and President of Cougar Biotechnology,
added, "We continue to be pleased with the clinical data
being generated on CB7630. We 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.
