* Highly Statistically Significant Results for Improvement in
Progression-Free Survival
* Progression-Free Survival Results Consistent Irrespective of Prior
Chemotherapy Treatment, including Taxotere(R)
* Satraplatin was Well Tolerated with Myelosuppression the Most Commonly
Observed Toxicity
* Data Being Presented Today at ASCO Prostate Cancer Symposium in Orlando,
Florida
* GPC Biotech Conference Call Scheduled Today at 9:00 AM EST
* Pharmion Investor Event Scheduled Today at 6:30 PM EST
MARTINSRIED/MUNICH, Germany, Feb. 23 /PRNewswire-FirstCall/ -- U.S.
Research and Development Facilities in Waltham, Mass., Princeton, N.J. and
Boulder, Colo. -- GPC Biotech AG (Frankfurt Stock Exchange: GPC; TecDAX
index; Nasdaq: GPCB) and Pharmion Corporation (Nasdaq: PHRM) today
announced that final progression-free survival (PFS) results for the
double-blind, randomized satraplatin Phase 3 registrational trial, the
SPARC trial (Satraplatin and Prednisone Against Refractory Cancer) are
being presented today at the ASCO Prostate Cancer Symposium in Orlando,
Florida. The trial is evaluating satraplatin plus prednisone versus placebo
plus prednisone in 950 patients with hormone-refractory prostate cancer
(HRPC) who have failed prior chemotherapy. All analyses of PFS being
presented were conducted on an intent-to-treat basis.
The study data show that satraplatin significantly reduces the risk of
disease progression in these patients using the protocol-specified log-rank
test. The hazard ratio of 0.6 (95% CI: 0.5-0.7, p<0.00001), which was first
reported in September 2006, adjusted for nine pre-specified prognostic
factors. Using a more conservative analysis, which adjusted only for the
three pre-specified stratification factors, the hazard ratio is 0.67 (95%
CI: 0.57-0.77, p=0.0000003). These hazard ratio numbers correspond to a
reduction in relative risk of disease progression of 40% and 33%,
respectively. Both analyses are being presented today in Orlando.
In accordance with the recommendation of the independent Data
Monitoring Board for the SPARC trial, patients who have not progressed
continue to be treated and all patients will be followed for overall
survival. Overall survival data are expected to be available later this
year. GPC Biotech recently completed the New Drug Application (NDA)
submission for satraplatin to the U.S. Food and Drug Administration (FDA).
Pharmion expects to complete the Marketing Authorization Application (MAA)
for Europe in the second quarter of 2007.
Daniel Petrylak, M.D., Associate Professor of Medicine at Columbia
University College of Physicians & Surgeons, Director of the Genitourinary
Oncology Program at New York-Presbyterian Hospital/Columbia, and a
Principal Investigator in the SPARC trial, said: "As there are currently no
approved therapies for patients with hormone-refractory prostate cancer
whose disease has already failed on one chemotherapy regimen, satraplatin
has the potential to address a mounting area of unmet medical need. The
data I am presenting today show statistically significant results in
progression-free survival in favor of those patients treated with
satraplatin. These results are consistent no matter what the prior
chemotherapy treatment, including Taxotere(R)."
All disease progression events were adjudicated by an independent
expert review committee of medical oncologists and radiologists. The vast
majority of progression events were based on radiological progressions and
pain progressions. Pain associated with bone metastases is the dominant
cause of morbidity in patients with metastatic HRPC. Increase in prostate
specific antigen (PSA) was not part of the progression endpoint. PFS at the
median demonstrated a 14% improvement in patients who received satraplatin
plus prednisone (11.1 weeks) compared to patients who received prednisone
plus placebo (9.7 weeks). The improvement seen in PFS by patients treated
with satraplatin increased over time. PFS at the 75th percentile showed an
81% improvement for patients in the satraplatin arm (34.6 weeks) versus
patients in the placebo arm (19.1 weeks). At six months, 30% of patients in
the satraplatin arm had not progressed, compared to 17% of patients in the
control arm. At twelve months, 16% of patients who received satraplatin had
not progressed, compared to 7% of patients in the control arm.
The median number of cycles was four for the satraplatin group compared
to two for the control group. Nearly 40% of patients treated with
satraplatin received five or more cycles of treatment compared to
approximately 20% of patients in the control arm.
The improvement in PFS in the satraplatin arm was not affected by the
type of prior chemotherapy; importantly, the improvement was similar for
patients who had received prior Taxotere(R) (docetaxel), as well as those
who received other types of chemotherapy treatments. Fifty-one percent of
patients in the trial were previously treated with Taxotere. The hazard
ratio for patients in the SPARC trial who were previously treated with
Taxotere was 0.67 (95% CI: 0.54-0.83; p=0.0006, adjusted for the
pre-specified stratification factors) and therefore numerically equivalent
to the entire study population.
Safety findings were consistent with previous clinical studies
involving satraplatin. The reported adverse reactions were mostly mild to
moderate in severity. The most common adverse reactions consisted of
myelosuppression (bone marrow functions): Twenty-one percent of patients in
the satraplatin arm experienced grade 3 or 4 thrombocytopenia; 14 percent
had leucopenia and 21 percent had neutropenia. Eight percent of patients in
the satraplatin arm experienced grade 3 or 4 gastrointestinal toxicities,
including nausea, vomiting, diarrhea and constipation. Five percent or less
of patients in the satraplatin arm experienced grade 3 or 4 fatigue, grade
3 or 4 infections and pulmonary/respiratory grade 3 or 4 toxicities.
"We are delighted with the strong detailed results presented today from
the satraplatin SPARC Phase 3 trial," said Bernd R. Seizinger, M.D., Ph.D.,
Chief Executive Officer of GPC Biotech. "Moving forward, we plan to work
closely with the FDA regarding our application for marketing approval of
satraplatin in the U.S. We also are continuing to aggressively build our
marketing and sales organization in the U.S. to prepare for a potential
launch of satraplatin later this year."
"We have been very pleased with the response of the prostate cancer
treatment community to the SPARC data and believe that satraplatin will
become a very important treatment option for men with HRPC," said Patrick
J. Mahaffy, President and Chief Executive Officer of Pharmion Corporation.
"We are currently preparing our regulatory submission and expect to file a
marketing authorization application for satraplatin in the EU by the end of
the second quarter."
The SPARC trial is a double-blinded, randomized, placebo-controlled
multinational Phase 3 trial assessing satraplatin plus prednisone as a
second- line chemotherapy treatment for patients with HRPC. A total of 950
patients were accrued to the trial at approximately 170 clinical sites in
sixteen countries on four continents. In addition to the results presented
today, the companies expect that more data from the SPARC trial will be
presented at future upcoming major medical conferences.
GPC Biotech and Pharmion Investor Events
GPC Biotech will hold a conference call today at 9:00 A.M. EST/15:00
CET to which participants may listen via live webcast, accessible through
the Company's Web site at http://www.gpc-biotech.com, or via telephone. Dr. Daniel
Petrylak will participate in the call, in addition to corporate management.
The dial-in numbers for the call are as follows:
Participants from Europe: 0049 (0) 69 2222 2246 or
0044 (0) 20 7138 0835
Participants from the U.S.: 1-718-354-1172
Pharmion will hold an investor event today at 6:30 P.M. EST in Emerald
4 at the Gaylord Palms Resort and Conference Center in Orlando, Florida.
For those unable to attend, the event will be accessible via a
teleconference and will be webcast live on our website at http://www.pharmion.com.
The dial in for U.S. participants is 1.800.901.5231 and 1.617.786.2961 for
International participants. The passcode is 84420838. Corporate management
will briefly review today's data and then a panel of European physicians
will discuss their clinical experience with satraplatin and its potential
role in the treatment of HRPC in Europe.
About Prostate Cancer
Prostate cancer is the most common cancer among men in the U.S. and
Europe. Approximately 219,000 men in the U.S. are expected to be diagnosed
with the disease in 2007 and over 27,000 men are expected to die from the
disease. In the European Union, over 200,000 new cases are expected to be
diagnosed, and over 60,000 patients are expected to die each year. Since
the incidence of prostate cancer increases with age, the aging of the
overall population is expected to further increase the number of prostate
cancer patients.
Most patients diagnosed with prostate cancer initially receive surgery
or radiation therapy, and some of these patients are cured. For many
others, though, the disease recurs. At this point, the recurrent disease is
treated with hormone therapy, and most patients initially respond well to
this treatment. Eventually, however, the tumor cells become resistant to
the hormones -- or "hormone-refractory" -- and the tumor again progresses.
Increasingly, chemotherapy is being used as an effective first-line
treatment for hormone-refractory prostate cancer. However, it is not a
cure, and so this is creating a need for effective therapeutic options for
these patients once they have progressed.
About Satraplatin
Satraplatin, an investigational drug, is a member of the platinum
family of compounds. Over the past two decades, platinum-based drugs have
become a critical part of modern chemotherapy treatments and are used to
treat a wide variety of cancers. Unlike the platinum drugs currently on the
market, all of which require intravenous administration, satraplatin is an
orally bioavailable compound and is given as capsules that patients can
take at home.
GPC Biotech and Pharmion have a co-development and license agreement
under which Pharmion has been granted exclusive commercialization rights to
satraplatin for Europe and certain other territories.
Satraplatin has been studied in clinical trials involving a range of
tumors. Trials evaluating the effects of satraplatin in combination with
radiation therapy, in combination with other cancer therapies and in a
number of cancer types are underway or planned. GPC Biotech in-licensed
satraplatin from Spectrum Pharmaceuticals, Inc. in 2002. Additional
information on satraplatin can be found in the Anticancer Programs section
of the GPC Biotech Web site at http://www.gpc-biotech.com.
About Pharmion
Pharmion is a biopharmaceutical company focused on acquiring,
developing and commercializing innovative products for the treatment of
hematology and oncology patients in the U.S., Europe and additional
international markets. Pharmion has a number of products on the market
including the world's first approved epigenetic cancer drug, Vidaza(R), a
DNA demethylating agent. For additional information about Pharmion, please
visit Pharmion's website at http://www.pharmion.com.
About GPC Biotech
GPC Biotech AG is a biopharmaceutical company discovering and
developing new anticancer drugs. GPC Biotech's lead product candidate --
satraplatin -- has achieved target enrollment in a Phase 3 registrational
trial as a second-line chemotherapy treatment in hormone-refractory
prostate cancer. The U.S. FDA has granted fast track designation to
satraplatin for this indication, and GPC Biotech has completed the rolling
NDA submission process for this compound. GPC Biotech is also developing a
monoclonal antibody with a novel mechanism-of-action against a variety of
lymphoid tumors, currently in Phase 1 clinical development, and has ongoing
drug development and discovery programs that leverage its expertise in
kinase inhibitors. GPC Biotech AG is headquartered in Martinsried/Munich
(Germany), and its wholly owned U.S. subsidiary has sites in Waltham,
Massachusetts and Princeton, New Jersey. For additional information, please
visit GPC Biotech's Web site at http://www.gpc-biotech.com.
This press release contains forward-looking statements, which express
the current beliefs and expectations of the management of GPC Biotech AG
and Pharmion Corporation, including statements relating to results of the
SPARC trial and statements relating to the potential efficacy and safety
profile 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. In particular, there can be no guarantee
that additional information relating to the safety, efficacy or
tolerability of satraplatin may be discovered upon further analysis of data
from the SPARC trial or analysis of additional data from other ongoing
clinical trials for satraplatin. Furthermore, we cannot guarantee that
satraplatin will be approved for marketing in a timely manner, if at all,
by regulatory authorities nor that, if marketed, satraplatin will be a
successful commercial product. We direct you to GPC Biotech's Annual Report
on Form 20-F for the fiscal year ended December 31, 2005, Pharmion's Annual
Report on Form 10-K for the fiscal year ended December 31, 2005, its most
recent filings on Form 10-Q 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
either Pharmion or GPC Biotech. Forward- looking statements speak only as
of the date on which they are made and neither Pharmion nor GPC Biotech
undertakes any obligation to update these forward-looking statements, even
if new information becomes available in the future.
The scientific information discussed in this press release related to
satraplatin is investigative. Satraplatin has not yet 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(R) (docetaxel) is a registered trademark of Aventis Pharma
S.A.
Editor's Note: A virtual press kit is available for downloading from
the News and Media section of the GPC Biotech website at
http://www.gpc-biotech.com/en/news_media/virtual_press_kit/index.html or by
contacting one of the GPC Biotech individuals listed below.
For further information, please contact:
GPC Biotech AG
Martin Braendle
Director, Investor Relations & Corporate Communications
Phone: +49 (0)89 8565-2693
ir@gpc-biotech.com
In the U.S.: Laurie Doyle
Director, Investor Relations & Corporate Communications
Phone: +1 781 890 9007 X267
usinvestors@gpc-biotech.com
Pharmion Corporation
Breanna Burkart/Anna Sussman
Directors, Investor Relations and Corporate Communications
Phone: 720.564.9150
ir@pharmion.com
Additional Media Contacts for GPC Biotech:
In Europe:
Maitland Noonan Russo
Brian Hudspith
Phone: +44 (0)20 7379 5151
bhudspith@maitland.co.uk
In the U.S.:
Noonan Russo
David Schull
Phone: +1 212 845-4271
david.schull@eurorscg.com
SOURCE GPC Biotech AG
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Related links:
http://www.gpc-biotech.com
http://www.pharmion.com
CONTACT:
Martin Braendle, Director, Investor Relations
& Corporate Communications, +49-89-8565-2693, ir@gpc-biotech.com,
or Laurie Doyle, Director, Investor Relations & Corporate
Communications, +1-781-890-9007 ext. 267,
usinvestors@gpc-biotech.com, both of GPC Biotech AG; Breanna
Burkart, or Anna Sussman, both Directors, Investor Relations and
Corporate Communications, Pharmion Corporation, +1-720-564-9150,
ir@pharmion.com; or In the Europe: Brian Hudspith of Maitland
Noonan Russo, +44-0-20-7379-5151, bhudspith@maitland.co.uk; or In
the U.S.: David Schull, +1-212-845-4271,
david.schull@eurorscg.com
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