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Poniard Pharmaceuticals Announces Positive First-line Phase 1 Safety And Efficacy Data With Picoplatin In Metastatic Prostate Cancer Patients
Poniard
Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused
on oncology, announced that it is presenting safety and efficacy data
in prostate cancer patients from its Phase 1 study of picoplatin, the
Company's lead product candidate, at the 2008 Genitourinary (GU) Cancers
Symposium, a meeting of the American Society of Clinical Oncology (ASCO)
that is being held in San Francisco.
The poster presentation includes safety and efficacy data from a
dose-escalating Phase 1 study of picoplatin in combination with full-dose
docetaxel (75 mg/m squared) with prednisone as a first-line treatment for
metastatic hormone refractory prostate cancer (mHRPC). The Phase 1 study
sought to establish the maximum tolerated dose of picoplatin and provide
information on the safety and efficacy of picoplatin in combination with
docetaxel and prednisone, the standard of care for the first-line treatment
of mHRPC.
"The data we have generated with picoplatin in prostate cancer indicate
a PSA (prostate specific antigen) response of 65 percent which suggests an
improvement compared to docetaxel therapy alone," said Jerry McMahon,
Ph.D., chairman and CEO of Poniard Pharmaceuticals. "In addition, the
tolerability of picoplatin with full-dose docetaxel supports our ongoing
Phase 2 study that we believe will confirm and extend these initial
findings. The combination of platinums and taxanes, such as docetaxel, is
used to treat many other solid tumors, such as non-small cell and ovarian
cancers. We believe that our data support additional evaluation of
picoplatin and docetaxel combinations in these cancers in addition to
prostate cancer."
In the combination Phase 1 dose-escalating study, 33 patients were
treated with one of four doses (60, 80, 100 or 120 mg/m squared) of
picoplatin, as well as either 60 mg/m squared or 75 mg/m squared
(full-dose) docetaxel plus 5 mg prednisone twice daily. Nine patients
received 120 mg/m squared picoplatin and 75 mg/m squared docetaxel every 21
days plus 5 mg prednisone twice daily. This dose, which is also the dose
currently under study in the Phase 2 trial, was well tolerated.
Hematological toxicity, including neutropenia, anemia and
thrombocytopenia, was dose-dependent and reversible. Neutropenia was the
dose-limiting toxicity (DLT). Mild neuropathy (grade 1) was observed in 3
of 33 patients (9 percent) and was unrelated to cumulative picoplatin dose.
Neuropathy was infrequent, and no neuropathy of grade 2 or greater was
observed. PSA response rate was 65 percent (20 of 31 evaluable patients).
Survival data are not yet available. Patient withdrawal from study
treatment occurred from death in four patients, progressive disease in
eight patients, and withdrawal of consent in one patient. Patients in the
Phase 1 trial received a median number of 7 cycles, and 13 of 33 patients
completed the maximum of 10 cycles of treatment according to the study
protocol.
Based on safety and efficacy data from the Phase 1 study, the
recommended Phase 2 regimen of intravenous picoplatin (120 mg/m squared)
and docetaxel (75 mg/m squared) every 21 days with prednisone (5 mg) orally
twice daily is being evaluated in a Phase 2 study in chemotherapy naive
mHRPC patients. PSA response is the primary endpoint; secondary endpoints
include radiological response using RECIST criteria, time to progression
and survival (1-year, progression-free and overall). The Phase 2 trial
completed enrollment in December 2007. The Company expects to present the
results of this study in scientific forums later this year.
About Picoplatin
Picoplatin is an intravenous chemotherapeutic agent that has an
improved safety profile compared to existing platinum-based
chemotherapeutics. It was designed to overcome platinum resistance
associated with the treatment of solid tumors. Picoplatin has been
evaluated in more than 800 patients and has demonstrated activity in
multiple indications with no evidence of significant kidney, nerve toxicity
or hearing loss, toxicities commonly observed with other platinum
chemotherapy drugs.
In addition to the Phase 2 clinical trial in patients with mHRPC,
Poniard is evaluating intravenous picoplatin in an ongoing pivotal Phase 3
trial, known as SPEAR (Study of Picoplatin Efficacy After Relapse), in
small cell lung cancer. This registrational trial is being conducted under
a Special Protocol Assessment from the U.S. Food and Drug Administration
and is evaluating overall survival as the primary endpoint. The Company
also is evaluating intravenous picoplatin in an ongoing Phase 2 clinical
trial for the treatment of colorectal cancer. Oral picoplatin is being
evaluated in a Phase 1 clinical trial in solid tumors.
About Poniard Pharmaceuticals
Poniard Pharmaceuticals, Inc. is a biopharmaceutical company focused on
the development and commercialization of innovative oncology products to
impact the lives of people with cancer. Picoplatin, the Company's lead
platform product candidate, is a new generation platinum therapy with an
improved safety profile. Picoplatin is designed to overcome and prevent
platinum resistance associated with chemotherapy in solid tumors, and is
being studied in multiple cancer indications, combinations and
formulations. Clinical trials of intravenous picoplatin include a Phase 3
trial in small cell lung cancer and Phase 2 trials in metastatic colorectal
and hormone-refractory prostate cancer, as well as a clinical trial of oral
picoplatin in solid tumors. Picoplatin has not been approved by regulatory
authority for use in humans. For additional information please visit
http://www.poniard.com.
This release contains forward-looking statements, including statements
regarding the Company's business objectives and strategic goals, drug
development plans, results of clinical trials and the potential safety and
efficacy of its products in development. The Company's actual results may
differ materially from those indicated in these forward-looking statements
based on a number of factors, including risks and uncertainties associated
with the Company's research and development activities; the results of
pre-clinical and clinical testing; the receipt and timing of required
regulatory approvals; the market's acceptance of the Company's proposed
products; the Company's anticipated operating losses, need for future
capital and ability to obtain future funding; competition from third
parties; the Company's ability to preserve and protect intellectual
property rights; the Company's dependence on third-party manufacturers and
suppliers; the Company's lack of sales and marketing experience; the
Company's ability to attract and retain key personnel; changes in
technology, government regulation and general market conditions; and the
risks and uncertainties described in the Company's current and periodic
reports filed with the Securities and Exchange Commission, including the
Company's Annual Report on Form 10-K for the year ended December 31, 2006,
as amended, and most current Quarterly Report on Form 10-Q. Readers are
cautioned not to place undue reliance on these forward-looking statements,
which speak only as of the date of this release. The Company undertakes no
obligation to update any forward-looking statement to reflect new
information, events or circumstances after the date of this release or to
reflect the occurrence of unanticipated events.
(C) 2008 Poniard Pharmaceuticals, Inc. All Rights Reserved. Poniard and
Poniard Pharmaceuticals are trademarks of Poniard Pharmaceuticals, Inc.
Poniard Pharmaceuticals, Inc.
http://www.poniard.com
Pumnal produse farmaceutice pozitiv anunta primul-linie Faza 1 siguranþa ºi eficacitatea în Picoplatin de date cu pacienþii cu cancer de prostatã metastazat - Poniard Pharmaceuticals Announces Positive First-line Phase 1 Safety And Efficacy Data With Picoplatin In Metastatic Prostate Cancer Patients - articole medicale engleza - startsanatate