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Medical Forum / Diseases and Disorders / Prostate Cancer / December 2005

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Satraplatin for HRPC Phase III Trial Filled

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c palmer - 06 Dec 2005 04:44 GMT
December 5, 2005

GPC Biotech completes enrolment in phase III trial for cancer drug
Satraplatin
AFX News Limited/Forbes.com, 12.05.2005

MARTINSRIED, Germany (AFX) - GPC Biotech AG said it has completed the
targeted enrolment of patients for its Phase III trial of the
Satraplatin drug to treat hormone-refractory prostate cancer (HRPC).

The Germany biotech company said more than 200 clinical sites in fifteen
countries have now accrued a total of 912 patients for the trial.

The trial, named SPARC (Satraplatin and Prednisone Against Refractory
Cancer), is a double blind, randomised study that is assessing the
safety and efficacy of Satraplatin in combination with prednisone as a
second-line chemotherapy in patients with hormone-refractory prostate
cancer (HRPC).

Second-line treatment means the patients have undergone no more than one
prior treatment regimen.

Satraplatin is a member of the platinum family of compounds and
worldwide sales of these drugs exceeded 2.2 bln usd in 2004.

The drug has also completed Phase II trials in ovarian cancer and small
cell lung cancer, and has started Phase II trials in breast cancer.

Several other studies evaluating Satraplatin in combination with other
therapies and in various cancers are underway or planned.

knowledge is power - growing old is mandatory - growing wise is optional    
"Many more men die with prostate cancer than of it. Growing old is
invariably fatal. Prostate cancer is only sometimes so."
http://community.webtv.net/PALMER_ENT/doc
J - 06 Dec 2005 09:12 GMT
> December 5, 2005
>
[quoted text clipped - 26 lines]
> Several other studies evaluating Satraplatin in combination with other
> therapies and in various cancers are underway or planned.

Satraplatin is the first orally administered platinum compound.
A Phase 3 study in Hormone Refractory Prostate Cancer began in September,
2003.
The primary endpoint of this study is time to disease progression.
Satraplatin was given fast track review designation by the FDA.

http://www.clinicaltrials.gov/ct/gui/show/NCT00069745
Exclusion Criteria:

   * More than one prior chemotherapy
   * Prior platinum containing compounds
   * Prior malignancy
   * Prior significant RT/radionuclide therapy
   * Major GI surgery or GI disease affecting absorption
   * Disease with contraindication to steroids
   * Brain metastases

http://www.medicalnewstoday.com/medicalnews.php?newsid=20470
Date: 01 Mar 2005
Phase III Trial of Satraplatin, an Oral Platinum plus Prednisone versus
Prednisone alone in Patients with Hormone Refractory Prostate Cancer: EORTC
Genitourinary Tract Group Protocol #30972," by C.N. Sternberg et al, reports
the data from this study. Summary data from the study were presented at the
2003 Annual Meeting of the American Society of Clinical Oncology (ASCO).

The published study involved 50 randomized patients at 18 medical centers
and evaluated the use of satraplatin plus prednisone (N=27) versus
prednisone alone (N=23) for use as a first-line chemotherapy treatment for
HRPC.

Prednisone is a synthetic hormone often used to relieve some of the symptoms
of advanced prostate cancer. The study results showed that satraplatin
treatment significantly lengthened progression-free survival (p=0.023): The
median time to disease progression or death was 5.2 months for satraplatin
versus 2.5 months for the control arm. Additionally, at six months, 41% of
patients treated in the satraplatin arm were progression-free versus 22% of
patients in the control arm. The median overall survival time was 15 months
for patients treated in the satraplatin arm versus 12 months for patients in
the control arm, a numerical, but not statistically significant, difference.

This press release may contain projections or estimates relating to plans
and objectives relating to our future operations, products, or services;
future financial results; or assumptions underlying or relating to any such
statements; each of which constitutes a forward-looking statement subject to
risks and uncertainties, many of which are beyond our control. Actual
results could differ materially depending on a number of factors, including
the timing and effects of regulatory actions, the results of clinical
trials, the Company's relative success developing and gaining market
acceptance for any new products, and the effectiveness of patent protection.
There can be no guarantee that the SPARC trial will be completed in a timely
manner, if at all. Additionally, there can be no guarantee that satraplatin
will be approved for marketing in a timely manner, if at all.
 
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