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Keryx Biopharmaceuticals Announces That The SUN-MICRO Phase 3 Clinical Trial Failed To Meet Its Primary Efficacy Endpoint
Keryx Biopharmaceuticals,
Inc. (Nasdaq: KERX) announced top-line results from its SUN-MICRO
Phase 3 clinical trial of Sulonex (sulodexide) for the treatment of
diabetic nephropathy. The Company announced that this Phase 3 clinical
trial failed to meet the primary objective of the study, which was to
increase the proportion of patients that achieve therapeutic success at 6
months as compared to placebo over background therapy of maximal doses of
ACE-inhibitors or ARBs. Therapeutic success was defined as (i) conversion
from microalbuminuria to normoalbuminuria, as measured by
albumin/creatinine ratio (ACR), with at least a 25% reduction in ACR
relative to baseline ACR, or (ii) a 50% reduction in ACR relative to
baseline ACR. In addition, in reviewing the mean changes in ACR over time,
Sulonex and placebo appeared to be similar.
"We are all very disappointed with the outcome of this Study. While
this represents the end of one chapter for Keryx, it is not the end of
Keryx. Drug development is inherently risky and, accordingly, we have spent
the last several years building what we believe to be a promising product
portfolio in the event our lead drug failed. We plan to re-focus our
primary efforts and resources on rapidly moving Zerenex forward for ESRD
patients with hyperphosphotemia and Perifosine forward for cancer. Our goal
is to have Perifosine in a pivotal program this year and be well into our
Zerenex high-dose Phase 2 trial before the end of the year."
ABOUT KERYX BIOPHARMACEUTICALS, INC.
Keryx Biopharmaceuticals is focused on the acquisition, development and
commercialization of medically important, novel pharmaceutical products for
the treatment of life-threatening diseases, including renal disease and
cancer. Keryx is developing Zerenex(TM) (ferric citrate), an oral,
iron-based compound that has the capacity to bind to phosphate and form
non-absorbable complexes. Zerenex is currently in Phase 2 clinical
development for the treatment of hyperphosphatemia (elevated phosphate
levels) in patients with end-stage renal disease, or ESRD. The Company is
also developing KRX-0401 (perifosine), a novel, potentially first-in-class,
oral anti-cancer agent that modulates Akt, a protein in the body associated
with tumor survival and growth. KRX-0401 also modulates a number of other
key signal transduction pathways, including the JNK and MAPK pathways,
which are pathways associated with programmed cell death, cell growth, cell
differentiation and cell survival. KRX-0401, which is currently in Phase 2
clinical development for multiple tumor types, is expected to move into a
Phase 3 clinical program in 2008. The Company also has an active
in-licensing and acquisition program designed to identify and acquire
additional drug candidates.
Cautionary Statement
As the Company has indicated in its public filings, among other things,
clinical trials have a high risk of failure. A number of companies in the
pharmaceutical industry, including biotechnology companies, have suffered
significant setbacks in advanced clinical trials, even after achieving what
appeared to be promising results in earlier trials.
Furthermore, as indicated in previous filings, interim results of
preclinical or clinical studies do not necessarily predict their final
results, and acceptable results in early studies might not be obtained in
later studies. Drug candidates in the later stages of clinical development
may fail to show the desired safety and efficacy traits despite positive
results in initial clinical testing.
Additionally, as indicated in previous filings, there can be no
assurance that the results from the Sulonex Phase 3 study will track the
data from the pilot Collaborative Study Group Phase 2 study or the DiNAS
Phase 2 study. Results from these earlier Sulonex studies may not be
indicative of results from future clinical trials and the risk remains that
the pivotal program for Sulonex may generate efficacy data that will be
insufficient for the approval of the drug, or may raise safety concerns
that may prevent approval of the drug.
Some of the statements included in this press release anticipating
future clinical and business prospects for our lead drug candidate Sulonex,
may be forward-looking statements that involve a number of risks and
uncertainties. For those statements, we claim the protection of the safe
harbor for forward- looking statements contained in the Private Securities
Litigation Reform Act of 1995. Among the factors that could cause our
actual results to differ materially are the following: if, upon final
analysis, it is determined that all trials of Sulonex should be terminated,
our ability to successfully adjust our strategy and reduce our operating
expenses in order to properly support the trials of our other drug
candidates; if, upon final analysis of the Phase 3 data, it is determined
that dosing should continue in the Phase 4 study, our ability to complete
enrollment into the Phase 4 study on the timetable previously set for
completion of Phase 4; our ability to complete cost- effective clinical
trials or meet anticipated development timelines for the other drug
candidates in our pipeline, including Zerenex and KRX-0401; or other risk
factors identified from time to time in our reports filed with the
Securities and Exchange Commission. Any forward-looking statements set
forth in this press release speak only as of the date of this press
release. We do not intend to update any of these forward-looking statements
to reflect events or circumstances that occur after the date hereof. This
press release and prior releases are available at http://www.keryx.com. The
information in our website is not incorporated by reference into this press
release and is included as an inactive textual reference only.
Keryx Biopharmaceuticals, Inc.
http://www.keryx.com
Keryx Biopharmaceuticals anunþã cã soarele micro-studiu clinic de fazã 3 nu a reuºit sã îºi îndeplineascã principal de evaluare - Keryx Biopharmaceuticals Announces That The SUN-MICRO Phase 3 Clinical Trial Failed To Meet Its Primary Efficacy Endpoint - articole medicale engleza - startsanatate