Abiraterone trial expanded

I noted the following from Cougar Biotechnology.....
--snip---

February 10, 2009
Cougar Biotechnology Announces Agreement with FDA on Special Protocol
Assessment for Phase III Trial of CB7630 (Abiraterone Acetate) in
Chemotherapy Naïve Castration Resistant Prostate Cancer Patients
Los Angeles, CA, February 10, 2009 -- Cougar Biotechnology, Inc.
(NASDAQ: CGRB) today announced that it has reached agreement with the
U.S. Food and Drug Administration (FDA) under a Special Protocol
Assessment (SPA) for its planned Phase III clinical trial of the
Company's lead drug candidate CB7630 (abiraterone acetate) in patients
with chemotherapy naïve castration resistant prostate cancer. The SPA
is a written agreement between the Company, as the trial's sponsor, and
the FDA regarding the design, endpoints, and planned statistical
analysis approach of the Phase III trial to be used in support of a New
Drug Application (NDA). The European Medicines Agency (EMEA) has also
provided protocol advice consistent with that of the FDA regarding the
Company's Phase III trial design and ability to support the submission
of an EU Market Authorization Application (MAA).
Pursuant to the SPA, the Phase III trial will be a randomized,
double-blind, placebo-controlled trial of CB7630 plus prednisone in
patients with metastatic castration resistant prostate cancer who have
not yet received treatment with chemotherapy. The trial is expected to
enroll approximately 1,000 patients who will be randomized (1:1) to
receive either CB7630 plus prednisone or placebo plus prednisone. The
trial will be conducted at approximately 150 sites in North America,
Europe and Australia. The agreed upon co-primary endpoints of the trial
are progression free survival and overall survival. The Company plans to
use the progression free survival data from the trial as the basis for
submission of an NDA/MAA for Accelerated or Conditional Approval from
the regulatory agencies. Cougar anticipates that it will begin patient
enrollment in this Phase III trial later this quarter.
Alan H. Auerbach, Chief Executive Officer and President of Cougar
Biotechnology, said, "Obtaining FDA agreement on the overall Phase III
trial design, and more specifically patient population and primary
endpoints, represents an important milestone in the global development
of CB7630 and for Cougar as a company."
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 be able to reach agreement with the FDA on our Phase
III trial design for patients with chemotherapy naïve castration
resistant prostate cancer. We look forward to commencing patient
enrollment in this Phase III trial shortly."

On Feb 17, 12:39 am, wa5...@webtv.net (R L) wrote:
> I noted the following from Cougar Biotechnology.....
> --snip---
>
> February 10, 2009
> Cougar Biotechnology Announces Agreement with FDA on Special Protocol
> Assessment for Phase III Trial of CB7630 (Abiraterone Acetate) in
> Chemotherapy Naïve Castration Resistant Prostate Cancer Patients
> Los Angeles, CA, February 10, 2009 -- Cougar Biotechnology, Inc.
> (NASDAQ: CGRB) today announced that it has reached agreement with the
> U.S. Food and Drug Administration (FDA) under a Special Protocol
> Assessment (SPA) for its planned Phase III clinical trial of the
> Company's lead drug candidate CB7630 (abiraterone acetate) in patients
> with chemotherapy naïve castration resistant prostate cancer. The SPA
> is a written agreement between the Company, as the trial's sponsor, and
> the FDA regarding the design, endpoints, and planned statistical
> analysis approach of the Phase III trial to be used in support of a New
> Drug Application (NDA). The European Medicines Agency (EMEA) has also
> provided protocol advice consistent with that of the FDA regarding the
> Company's Phase III trial design and ability to support the submission
> of an EU Market Authorization Application (MAA).
> Pursuant to the SPA, the Phase III trial will be a randomized,
> double-blind, placebo-controlled trial of CB7630 plus prednisone in
> patients with metastatic castration resistant prostate cancer who have
> not yet received treatment with chemotherapy. The trial is expected to
> enroll approximately 1,000 patients who will be randomized (1:1) to
> receive either CB7630 plus prednisone or placebo plus prednisone. The
> trial will be conducted at approximately 150 sites in North America,
> Europe and Australia. The agreed upon co-primary endpoints of the trial
> are progression free survival and overall survival. The Company plans to
> use the progression free survival data from the trial as the basis for
> submission of an NDA/MAA for Accelerated or Conditional Approval from
> the regulatory agencies. Cougar anticipates that it will begin patient
> enrollment in this Phase III trial later this quarter.
> Alan H. Auerbach, Chief Executive Officer and President of Cougar
> Biotechnology, said, "Obtaining FDA agreement on the overall Phase III
> trial design, and more specifically patient population and primary
> endpoints, represents an important milestone in the global development
> of CB7630 and for Cougar as a company."
> 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 be able to reach agreement with the FDA on our Phase
> III trial design for patients with chemotherapy naïve castration
> resistant prostate cancer. We look forward to commencing patient
> enrollment in this Phase III trial shortly."

I noticed this release last week. This is an encouraging sign. If, as
it appears in the release, that progression is an end point that will
trigger approval, rather than waiting for survival, which may take
years for chemo naive patients, then this trial can bring a new drug
into play at an earlier time in the disease, at the time when it would
most likely be used by doctors and patients, in any case. Nearly all
(all?) treatments for any cancer will be more effective at an earlier
stage when tumor load is less.The company must not be basing this on
the results of the current phase III trial in post chemo patients
since there has been no information forthcoming from that trial. This
does express confidence in their drug. This will be expensive to the
shareholders of Cougar for 1,000 patients and worldwide recruitment.
This may also be a supporting trial in case the current one is not
successful. The current trial was subscribed very quickly and I expect
that this will be as well. If anyone is interested I think prompt
response will be important.
There is also a current Phase I trial of TAK-700 which is a cyp17
target drug and works similarly to Abiraterone acetate. At least we
hope it does.