Gpc Biotech AG ADS (MM) (NASDAQ:GPCB)
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GPC Biotech AG (Frankfurt Stock Exchange: GPC, NASDAQ: GPCB) today
announced the presentation of the overall survival results from the
double-blind, randomized satraplatin Phase 3 registrational trial, the
SPARC trial (Satraplatin and Prednisone Against Refractory Cancer). The
data were presented at the 44th Annual Meeting
of the American Society for Clinical Oncology (ASCO) in Chicago. The
SPARC trial evaluated satraplatin plus prednisone versus placebo plus
prednisone in 950 patients with hormone-refractory prostate cancer
(HRPC) that had progressed after initial chemotherapy.
While data presented previously did show a statistically significant
improvement in the progression-free survival endpoint, the trial did not
achieve the endpoint of overall survival (p=0.80, log rank analysis) for
the intent-to-treat (ITT) population. The median was 61.3 weeks for the
satraplatin arm compared to 61.4 weeks for the control group, and the
hazard ratio, stratified by the pre-specified randomization factors1,
was 0.98 (95% CI: 0.84, 1.15). The median in the patient group
previously treated with docetaxel (Taxotere®)
was 66.1 weeks for the satraplatin arm compared to 62.9 weeks for the
control arm. The stratified hazard ratio was 0.91 (95% CI: 0.72, 1.14).
When adjusted for the three pre-specified prognostic factors which
showed statistically significant imbalances between the two treatment
arms (lactate dehydrogenase, hemoglobin and alkaline phosphatase), the
hazard ratio for the ITT group was 0.88 (95% CI: 0.74, 1.03).
Importantly, when adjusted for the three significant prognostic factors,
there was a positive trend observed in those patients who had progressed
after receiving docetaxel, with a hazard ratio of 0.78 (95% CI: 0.61,
0.99).
“There is a need for new therapies for
patients with hormone-refractory prostate cancer whose disease has
progressed after initial chemotherapy treatment,”
said A. Oliver Sartor, M.D., Piltz Endowed Professor of Cancer Research
and Professor of Medicine and Urology, Tulane Medical School, and one of
the principal investigators of the SPARC trial. “While
satraplatin did not improve overall survival in the intent-to-treat
population, there was a positive trend observed in patients who
progressed after Taxotere treatment when adjusted for significant
prognostic factors. Additionally, I believe that satraplatin has been
shown to be a well tolerated treatment that has demonstrated an
important benefit for patients by showing a statistically significant
improvement in progression-free survival, as well as pain, tumor and PSA
response rates in the overall patient population.”
Of note, a significant number of patients received additional cancer
therapies after they progressed in the SPARC trial. In the control arm,
68.6% of patients received some form of third-line therapy, including
chemotherapy, immunotherapy and other treatments, versus 61.7% of
patients in the satraplatin arm. In the control arm, 52.4% of patients
received chemotherapy compared to 44.7% in the satraplatin arm, and
24.4% of patients in the control arm were treated with Taxotere
following progression in the SPARC trial compared to 18.3% in the
satraplatin arm. Taxotere is considered the standard of care in the
first-line treatment of HRPC patients in the United States and many
countries in Europe.
Safety findings in the SPARC trial were consistent with previous
clinical studies involving satraplatin. Myelosuppression (decrease in
the production of blood cells by the bone marrow) was the most common
adverse reaction associated with satraplatin therapy, with 98.9% of
patients in the satraplatin arm experiencing myelosuppression of any
grade. A total of 22.6% of patients in the satraplatin arm experienced
grade 3 or 4 thrombocytopenia; 14.5% had grade 3 or 4 leucopenia; 22.3%
had grade 3 or 4 neutropenia and 11.9% experienced grade 3 or 4 anemia.
Gastrointestinal toxicities of any grade were the most frequent
non-hematological adverse events (occurring in 59.5% of the patients
receiving satraplatin). A total of 7.8% of patients in the satraplatin
arm experienced grade 3 or 4 gastrointestinal toxicities, including
nausea (1.4%), vomiting (1.6%), diarrhea (1.9%) and constipation (1.9%).
Additionally, 5% or less of patients in the satraplatin arm experienced
grade 3 or 4 fatigue (1.9%), grade 3 or 4 infections (4.3%) and
pulmonary/respiratory grade 3 or 4 toxicities (3.3%).
About Satraplatin
Satraplatin, an investigational drug, is a member of the platinum family
of compounds. Platinum-based drugs are a critical part of modern
chemotherapy treatments and are used to treat a wide variety of cancers.
All platinum drugs currently on the market require intravenous
administration. Satraplatin is an oral compound that clinical trial
patients are able to take at home. A Marketing Authorization Application
for satraplatin in combination with prednisone is currently under review
in Europe for the treatment of hormone-refractory prostate cancer
patients whose prior chemotherapy has failed. A decision on the filing
by the European regulators is expected in the second half of 2008.
Celgene Corporation is responsible for the regulatory filings for
satraplatin and its development and commercialization for Europe and
certain other territories. GPC Biotech also has a license agreement with
Yakult Honsha Co. Ltd. under which Yakult has exclusive
commercialization rights to satraplatin for Japan and is taking the lead
in developing the drug in that territory. GPC Biotech in-licensed
satraplatin from Spectrum Pharmaceuticals, Inc. in 2002.
About GPC Biotech
GPC Biotech AG is a publicly traded biopharmaceutical company focused on
anticancer drugs. GPC Biotech's lead product candidate is satraplatin,
an oral platinum compound. The Company has various anti-cancer programs
in research and development that leverage its expertise in kinase
inhibitors. GPC Biotech AG is headquartered in Martinsried/Munich
(Germany) and has a wholly owned U.S. subsidiary in Princeton, New
Jersey. For additional information, please visit GPC Biotech's Web site
at www.gpc-biotech.com.
This press release contains forward-looking statements, which express
the current beliefs and expectations of the management of GPC Biotech,
including statements about the efficacy and safety of satraplatin. Such
statements are based on current expectations and are subject to risks
and uncertainties, many of which are beyond our control, that could
cause future results, performance or achievements to differ
significantly from the results, performance or achievements expressed or
implied by such forward-looking statements. Actual results could differ
materially depending on a number of factors, and we caution investors
not to place undue reliance on the forward-looking statements contained
in this press release. Satraplatin may not be approved for marketing in
a timely manner, if at all. We direct you to GPC Biotech’s
Annual Report on Form 20-F for the fiscal year ended December 31, 2006
and other reports filed with the U.S. Securities and Exchange Commission
for additional details on the important factors that may affect the
future results, performance and achievements of GPC Biotech.
Forward-looking statements speak only as of the date on which they are
made and GPC Biotech undertakes no obligation to update these
forward-looking statements, even if new information becomes available in
the future.
Satraplatin has not been approved by the FDA in the U.S., the EMEA in
Europe or any other regulatory authority and no conclusions can or
should be drawn regarding its safety or effectiveness. Only the relevant
regulatory authorities can determine whether satraplatin is safe and
effective for the use(s) being investigated.
Taxotere®
is a registered trademark of Aventis Pharma S.A.
1 The three pre-specified randomization factors
for the SPARC trial were: 1) performance status at study entry, 2)
present pain intensity at study entry, and 3) type of disease
progression on first line therapy (PSA or symptomatic).