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Preliminary PI-88 Phase 2 Prostate Cancer Results To Be Presented At The American Society For Clinical Oncology 2008 Genitourinary Cancer Symposium
Progen
Pharmaceuticals Limited (ASX: PGL; Nasdaq: PGLA) announced positive
preliminary efficacy results from a phase 2 investigator-initiated trial of
PI-88 in combination with the chemotherapeutic agent Taxotere(R)
(docetaxel) administered to patients with prostate cancer. Dr. Gavin Marx,
Royal North Shore Hospital, Sydney Haematology and Oncology Clinics, the
principal investigator conducting the trial, will present the preliminary
results of the study at the American Society for Clinical Oncology
(ASCO) 2008 Genitourinary Cancer Symposium in San Francisco.
The investigator-initiated study was a randomized two-arm open-label
study design that assessed efficacy and safety of two dose schedules (4
days/week and 7 days/week) of subcutaneous PI-88 in combination with
three-weekly Taxotere(R) (75 mg/m2, IV on day 1). The study comprised a
lead-in phase 1 safety component to establish the maximum tolerated dose
(MTD) of PI-88 at each of the two dosing schedules, followed by a
randomized phase 2 component expanding the two dose schedule.
70% of the 55 patients recruited to the trial had a decrease in serum
Prostate Specific Antigen (PSA) of greater than 50% for three weeks or
longer. These efficacy results compare favourably with the pivotal TAX327
Taxotere(R) registration trial, where 45% of patients had at least a 50%
decrease in serum PSA level(1). PSA is a substance produced in the prostate
gland, a high level of which may indicate the presence of cancer. In
patients with advanced prostate cancer, many clinicians use increasing
levels of PSA as an indicator of disease progression.
The trial concluded enrollment early due to a higher-than-expected rate
of febrile neutropaenia, a side effect involving a decrease in white blood
cells with associated fever. This is a known side effect of Taxotere(R),
but was seen in this trial at a substantially greater rate than is
generally considered typical for that drug.
Two patients are continuing with PI-88 treatment after successfully
completing the combination treatment. Specifically, one patient has
remained on the study after 74 weeks while the other remains after 40
weeks.
Dr. James Garner, Progen's Vice President of Clinical and Medical
Affairs commented, "We are encouraged by the efficacy trends demonstrated
in this patient population. Prostate cancer is an indication with
continuing high unmet medical need and there is a clear demand for new
therapies here. The febrile neutropaenia rates seen in this study are
difficult to interpret, given that this small investigator-led study lacks
a control group. We have not seen evidence of febrile neutropaenia in our
previous clinical experience combining PI-88 with Taxotere(R), and there is
no biological reason to suspect that the combination might result in
increased toxicity. We will discuss this unexpected finding with our
clinical and scientific advisors to determine the appropriate next steps in
terms of development."
Justus Homburg, Progen's Chief Executive Officer continued, "Prostate
cancer continues to be an indication we are interested to explore more,
therefore, we will continue to analyze the results and do additional work
to establish how best to combine PI-88 with existing therapies in this
indication. In the interim, our phase 3 study in the adjuvant
hepatocellular carcinoma setting is expected to begin recruitment shortly.
We do not anticipate any concern regarding febrile neutropaenia in this
phase 3 study, as it is a monotherapy study in a patient population with
which we already have substantial clinical data."
About Progen: Progen Pharmaceuticals Limited is an Australian-based
globally focused biotechnology company committed to the discovery,
development and commercialization of small molecule therapeutics primarily
for the treatment of cancer.
About PI-88: PI-88 is one of a new class of multi-targeted cytostatic
cancer therapeutics. It is a novel anti-cancer compound with a
first-in-class mechanism as a heparan sulfate mimetic. Its anti-tumor
activity is based on inhibition of two biological processes -- angiogenesis
(the growth of new blood vessels) and metastasis (the spread of cancer to
other sites) -- critical to the growth and progression of cancer.
This press release contains forward-looking statements that are based
on current management expectations. These statements may differ materially
from actual future events or results due to certain risks and
uncertainties, including without limitation, risks associated with drug
development and manufacture, risks inherent in the extensive regulatory
approval process mandated by the United States Food and Drug Administration
and the Australian Therapeutic Goods Administration, delays in obtaining
the necessary approvals for clinical testing, patient recruitment, delays
in the conduct of clinical trials, market acceptance of PI-88, PI-166 and
other drugs, future capital needs, general economic conditions, and other
risks and uncertainties detailed from time to time in the Company's filings
with the Australian Securities Exchange and the United States Securities
and Exchange Commission. Moreover, there can be no assurance that others
will not independently develop similar products or processes or design
around patents owned or licensed by the Company, or that patents owned or
licensed by the Company will provide meaningful protection or competitive
advantages.
(1) Tannock et al, 2004, N. Engl J Med, 351, 1502-12
Progen Pharmaceuticals Limited
http://www.progen.com.au
View drug information on Taxotere.
Preliminar-88 pi faza 2 cancerului de prostatã rezultatele sã fie prezentate la societãþii americane clinice de oncologie pentru cancer genito-urinarã Simpozion 2008 - Preliminary PI-88 Phase 2 Prostate Cancer Results To Be Presented At The American Society For Clinical Oncology 2008 Genitourinary Cancer Symposium - articole medicale engleza - startsanatate