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Spectrum Pharmaceuticals Announces Initiation Of Phase 2 Trial Evaluating Satraplatin In Combination With Tarceva In Patients With Lung Cancer
Spectrum
Pharmaceuticals, Inc. (Nasdaq: SPPI) announced today that its partner, GPC
Biotech, has initiated a Phase 2 randomized trial evaluating satraplatin in
combination with Tarceva(R) (erlotinib) as a first-line therapy in patients
with inoperable, advanced non-small cell lung cancer (NSCLC) who are 70
years of age and older. A Phase 3 registration trial exploring satraplatin
in combination with prednisone as a second-line chemotherapy treatment for
patients with hormone-refractory prostate cancer has completed patient
enrollment. Additional clinical studies are being explored to explore the
potential of satraplatin as a single agent or in combination with different
drugs and other treatment modalities in a variety of tumor types.
The Phase 2 study in advanced NSCLC is a randomized trial that is
expected to involve more than 20 centers in the U.S. and Europe and enroll
approximately 120 patients. The primary objective of this study is to
evaluate progression-free survival. The study will also examine overall
survival, response rates and safety. Patients in the Phase 2 trial will be
randomized to receive satraplatin plus Tarceva or Tarceva alone. A
sequential dosing regimen will be used in the satraplatin arm. The
treatment cycle for both arms is 28 days. Patients will be stratified
according to smoking history and gender.
"We are pleased that our partner is committed to rapidly advancing
satraplatin through clinical development in multiple indications," stated
Rajesh Shrotriya, M.D., president and chief executive officer of Spectrum.
"Our partnership for the development of satraplatin is consistent with our
risk-reduced drug development strategy, and it provides us with a potential
source of non-dilutive funding with which we will advance our proprietary
oncology pipeline. If successful, we expect to begin receiving milestone
and royalty payments for satraplatin as early as next year, starting with
the acceptance by the FDA of the NDA submission of the drug for
hormone-refractory prostate cancer. The rolling NDA filing remains on
track, and is expected to be completed by end of the year"
About Lung Cancer
Lung cancer is the leading cause of cancer death in the U.S., with an
estimated 162,000 deaths expected from the disease in 2006. Over 170,000
new cases are expected to be diagnosed in 2006. The five-year survival rate
for lung cancer in the U.S. is only 15 percent. Recent statistics for
Europe estimated over 375,000 cases annually of lung cancer and over
345,000 deaths from the disease. NSCLC accounts for over 80% of all lung
cancer cases, and over 50% of patients present with inoperable disease.
Standard first-line chemotherapy for patients with advanced NSCLC
typically involves a combination regimen, frequently with a platinum-based
therapy. For elderly patients or patients with a poor performance status, a
single-agent chemotherapy may be recommended due to concerns about these
patients' ability to tolerate a combination regimen. Thus, there is a need
for well-tolerated, effective combination treatments.
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.
Spectrum out-licensed satraplatin to GPC Biotech AG in 2002, and GPC
Biotech fully funds all development expenses. In December 2005, the accrual
to the Phase 3 registrational trial was completed and the rolling
submission of a New Drug Application (NDA) for satraplatin with the U.S.
Food and Drug Administration (FDA) was initiated. Also in December 2005,
GPC Biotech signed a co-development and license agreement with Pharmion
GmbH, a wholly owned subsidiary of Pharmion Corporation, under which
Pharmion was granted exclusive commercialization rights to satraplatin for
Europe and certain other territories outside the U.S.
Satraplatin has been studied in clinical trials involving a range of
tumors, and Phase 2 trials have been completed in hormone-refractory
prostate cancer, ovarian cancer and small cell lung cancer. Other trials
evaluating the effects of satraplatin in combination with radiation
therapy, in combination with other cancer therapies and in various other
cancers are underway or planned.
About Spectrum
Spectrum Pharmaceuticals is opportunistically acquiring and advancing a
diversified portfolio of oncology drug candidates that meet critical health
challenges for which there are few other treatment options. Spectrum's
expertise lies in identifying undervalued drugs with demonstrated safety
and efficacy, and adding value through further clinical development and
selection of the most viable and low-risk methods of commercialization. The
company's pipeline includes promising early and late-stage drug candidates
with unique formulations and mechanisms of action that address the needs of
seriously ill patients, such as at-home chemotherapy and new treatment
regimens for refractory disease. For more information, please visit our
website at http://www.spectrumpharm.com.
Forward-Looking Statement
This press release may contain forward-looking statements regarding
future events and the future performance of Spectrum Pharmaceuticals that
involve risks and uncertainties that could cause actual results to differ
materially. These statements include but are not limited to statements that
relate to our business and its future, Spectrum's ability to identify,
acquire and develop its portfolio of drug candidates, the Company's
promising pipeline, that Spectrum will receive royalties from sales of
satraplatin, the expected number of centers and patients involved in the
Phase 2 study, that satraplatin provides us with a potential source of
non-dilutive funding with which we will advance our proprietary oncology
pipeline, that we will begin receiving milestone and royalty payments from
GPC Biotech for satraplatin as early as next year, the acceptance by the
FDA of the NDA submission of satraplatin for hormone-refractory prostate
cancer, that the rolling NDA filing will be completed by end of the year,
that other trials evaluating the effects of satraplatin in combination with
radiation therapy, in combination with other cancer therapies and in
various other cancers will be initiated and any statements that relate to
the intent, belief, plans or expectations of Spectrum or its management, or
that are not a statement of historical fact. Risks that could cause actual
results to differ include the possibility that our existing and new drug
candidates, may not prove safe or effective, the possibility that our
existing and new drug candidates may not receive approval from the FDA, and
other regulatory agencies in a timely manner or at all, the possibility
that our existing and new drug candidates, if approved, may not be more
effective, safer or more cost efficient than competing drugs, the
possibility that price and other competitive pressures may make the
marketing and sale of our generic drugs not commercially feasible, the
possibility that our efforts to acquire or in-license and develop
additional drug candidates may fail, our lack of revenues, our limited
experience in establishing strategic alliances, our limited marketing
experience, our limited experience with the generic drug industry, our
dependence on third parties for clinical trials, manufacturing,
distribution and quality control and other risks that are described in
further detail in the Company's reports filed with the Securities and
Exchange Commission. We do not plan to update any such forward-looking
statements and expressly disclaim any duty to update the information
contained in this press release except as required by law.
Spectrum Pharmaceuticals, Inc.
http://www.spectrumpharm.com/
View drug information on Tarceva.
Spectrul de Pharmaceuticals anunþã iniþierea Faza 2 Trial Evaluarea Satraplatin în asociere cu Tarceva, la pacienþii cu cancer pulmonar - Spectrum Pharmaceuticals Announces Initiation Of Phase 2 Trial Evaluating Satraplatin In Combination With Tarceva In Patients With Lung Cancer - articole medicale engleza - startsanatate