Patients treated with Satraplatin Demonstrated Statistically Significant
Improvement in Pain Response and PSA Response Rates
* Pain response rates of 24.2 percent for the satraplatin arm compared with
13.8 percent for the placebo arm (p=0.005)
* PSA response rates of 25.4 percent for the satraplatin arm compared with
12.4 percent for the placebo arm (p<0.001)
BERLIN, March 22 /PRNewswire-FirstCall/ -- GPC Biotech AG (Frankfurt
Stock Exchange: GPC; TecDAX index; Nasdaq: GPCB) and Pharmion Corporation
(Nasdaq: PHRM) today announced additional data from the double-blind,
randomized satraplatin Phase 3 registrational trial, the SPARC trial
(Satraplatin and Prednisone Against Refractory Cancer) which were presented
today at the 22nd Annual European Association of Urology Congress in
Berlin, Germany. 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.
"Second-line chemotherapy for patients with hormone-refractory prostate
cancer represents a true unmet medical need and the encouraging satraplatin
data suggest that for the first time, we may have a treatment option for
these patients with advanced disease," said Professor Fred Witjes,
Professor of Urology, Academisch Ziekenhuis, Nijmegen, The Netherlands. "In
particular, the very impressive pain and PSA response rates seen in the
SPARC study, especially considering the fact that all these patients were
progressive after hormones and chemotherapy, further suggest satraplatin's
active anti-tumor effect in this patient population."
Data presented today from the SPARC study showed that pain response
rates for patients treated with satraplatin were statistically
significantly superior compared to the pain response rates for those
patients in the comparator arm. Pain response rates were 24.2 percent for
the satraplatin plus prednisone arm compared with 13.8 percent for the
placebo arm (p=0.005).
Pain response was assessed by patients using a weekly present pain
intensity (PPI) and analgesic score. The PPI score was defined according to
the McGill-Melzack questionnaire with 0 = no pain, 1 = mild pain, 2 =
discomforting pain, 3 = distressing pain, 4 = horrible pain and 5 =
excruciating pain. The criteria for pain response are a greater than or
equal to 2 point reduction in the patients' weekly PPI score from baseline
and maintenance of the two point reduction for at least five consecutive
weeks in the setting of a stable or decreasing weekly analgesic score
compared to baseline. Patients were evaluable for pain response if their
baseline PPI score was greater than or equal to one and had completed four
consecutive weekly assessments of PPI and analgesic scores during the study
treatment.
Data from the SPARC trial also showed that the prostate specific
antigen (PSA) response rate for patients treated with satraplatin was
significantly improved compared to the PSA response rate for those patients
in the placebo
arm. PSA response rates were 25.4 percent for the satraplatin plus
prednisone arm compared with 12.4 percent for the placebo arm (p<0.001).
PSA response was analyzed using the widely adopted Bubley criteria of a
decrease of PSA level by greater than or equal to 50 percent from baseline,
with confirmation at least four weeks later.
Marcel Rozencweig, M.D., chief medical officer and senior vice
president, drug development of GPC Biotech said: "Patients with
hormone-refractory prostate cancer frequently suffer from terrible pain
associated with bone metastases. The satraplatin data presented today
continue to build on the progression-free survival data already presented
from the SPARC trial."
"We believe the PSA response rate provides important information
especially in this challenging second-line context," said Andrew Allen,
Pharmion's chief medical officer and executive vice president. "To see this
level of response for both pain and PSA is very encouraging and provides
important additional insight on the clinical profile of satraplatin in
patients with advanced prostate cancer."
The pain and PSA response analyses, in addition to the previously
presented PFS data, further define satraplatin's clinical profile as a
potential second-line treatment option in metastatic HRPC.
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. Pharmion expects to complete the Marketing Authorization Application
(MAA) for satraplatin for Europe in the second quarter of 2007. GPC Biotech
recently completed the New Drug Application (NDA) submission for
satraplatin to the U.S. Food and Drug Administration (FDA).
Safety findings were consistent with previous clinical studies
involving satraplatin. 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 (1.3%), vomiting (1.6%), diarrhea (2.1%) and constipation
(2.1%). 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.
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. GPC Biotech
in-licensed satraplatin from Spectrum Pharmaceuticals, Inc. in 2002.
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.
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 drug, Vidaza(R), a DNA
demethylating agent. For additional information about Pharmion, please
visit the company'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.
Safe Harbor Statement under the Private Securities Litigation Reform
Act of 1995:
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, 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 either GPC Biotech or Pharmion.
Forward-looking statements speak only as of the date on which they are made
and neither GPC Biotech nor Pharmion undertakes no 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.
GPC Biotech AG Contacts:
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 Contacts:
Breanna Burkart/Anna Sussman
Directors, Investor Relations and Corporate Communications
Pharmion Corporation
720-564-9150
Additional Media Contacts for GPC Biotech:
In Europe:
Maitland
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, or
ir@gpc-biotech.com, or Laurie Doyle, Director, Investor Relations
& Corporate Communications, +1-781-890-9007, ext. 267, or
usinvestors@gpc-biotech.com, both of GPC Biotech AG; or Breanna
Burkart or Anna Sussman, Directors, Investor Relations and
Corporate Communications, Pharmion Corporation, +1-720-564-9150;
or In the U.S.: David Schull of Noonan Russo, +1-212-845-4271, or
david.schull@eurorscg.com; or In Europe: Brian Hudspith of
Maitland Noonan Russo, +44 20 7379-5151, or
bhudspith@maitland.co.uk
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