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Cytokinetics Reports Data For Ispinesib In Recurrent And/or Metastatic Head And Neck Squamous Cell Carcinoma
Cytokinetics, Incorporated (Nasdaq: CYTK) announced results from a planned
interim analysis following Stage 1 of a two-stage Phase II clinical trial
of ispinesib administered as monotherapy in the treatment of patients with
recurrent and/or metastatic head and neck squamous cell carcinoma (RMHNSC).
This clinical trial was conducted by the National Cancer Institute (NCI)
under a collaboration with GlaxoSmithKline (GSK). A presentation entitled,
"A Phase II Study of Ispinesib in Patients with Recurrent and/or Metastatic
Head and Neck Squamous Cell Carcinoma" was made at the European Society of
Medical Oncology in Istanbul, Turkey on Monday, October 2, 2006, by
Patricia Tang, M.D. of the Princess Margaret Hospital Phase II Consortium,
Toronto, Canada.
This Phase II clinical trial was designed to evaluate the safety and
efficacy of ispinesib administered at 18 mg/m2 as an intravenous one hour
infusion once every 21 days in patients with RMHNSC, who had received no
more than one prior chemotherapy regimen. This two-stage clinical trial was
designed to require a minimum of 1 confirmed partial or complete response
out of 19 evaluable patients in Stage 1 in order to proceed to Stage 2. The
trial's primary endpoint was response rate as determined using RECIST
criteria. A total of 21 patients were enrolled; one patient did not receive
ispinesib due to disease progression prior to treatment, and another was
evaluable for safety but not efficacy.
At the interim analysis after Stage 1 of this clinical trial, ispinesib
in patients with RMHNSC at this dosing level did not satisfy the criteria
for advancement to Stage 2. The best overall response to date in this
clinical trial was disease stabilization, which was observed in 5 of the 19
patients evaluable for efficacy at cycle 2. Overall, median time to disease
progression was 5.9 (95% CI 5.4-10.0) weeks.
The safety and pharmacokinetics of ispinesib in this clinical trial
were evaluated in 20 of the patients enrolled in the trial. The most
frequently observed adverse events of any grade that were viewed by the
investigator to be possibly related to ispinesib (percent of patients
treated) were leukopenia (65%) and neutropenia (65%). Other common adverse
events included nausea (35%), hyponatremia (30%), fatigue (25%),
lymphopenia (25%), anemia (20%), injection site reaction (15%), vomiting
(15%), and bone pain (5%). The most common grade 3 or greater adverse event
was neutropenia, occurring in 55% of patients treated. Two patients died on
study. One death in a patient with a non-neutropenic infection (grade 3)
was attributed to progressive disease, the other, in a patient with four
days of grade 3-4 neutropenia, was attributed to pneumonia.
Background on KSP Inhibitors
Since their introduction over 40 years ago, anti-mitotic drugs (taxanes
and vinca alkaloids) have advanced the treatment of cancer and are commonly
used for the treatment of several tumor types. However, these drugs have
demonstrated limited treatment benefit against certain cancers. In
addition, these drugs target tubulin, a cytoskeletal protein involved not
only in mitosis and cell proliferation, but also in other important
cellular functions. Inhibition of these other cellular functions produces
dose-limiting toxicities such as peripheral neuropathy, an impairment of
the peripheral nervous system. Neuropathies result when these drugs
interfere with the dynamics of microtubule filaments that are responsible
for the long-distance transport of important cellular components within
nerve cells.
The strategic alliance established between Cytokinetics and GSK in 2001
has yielded two novel drug candidates that inhibit kinesin spindle protein
(KSP), ispinesib (SB-715992) and SB-743921. Ispinesib and SB-743921 are
structurally distinct small molecule compounds that modulate cell
proliferation and promote cancer cell death by specifically inhibiting KSP.
KSP is a mitotic kinesin that is essential for cell proliferation, a
process which, when unregulated, results in tumor growth. Mitotic kinesins
are essential to mitosis, and, unlike tubulin, appear to have no role in
unrelated cellular functions. We believe that drugs that inhibit KSP and
other mitotic kinesins may represent the next generation of anti-mitotic
cancer drugs by arresting mitosis and cell proliferation without impacting
unrelated, normal cellular functions, thus potentially avoiding many of the
toxicities commonly experienced by patients treated with existing
anti-mitotic drugs.
About Ispines
Ispinesib is a novel small molecule inhibitor of KSP, a mitotic kinesin
protein essential for proper cell division. Ispinesib is the first drug
candidate in clinical development that has arisen from a broad strategic
collaboration between Cytokinetics and GSK to discover, develop and
commercialize novel small molecule therapeutics targeting human mitotic
kinesins for applications in the treatment of cancer and other diseases.
GSK is conducting a broad clinical trials program for ispinesib designed to
study this drug candidate in multiple tumor types, combination regimens and
dosing schedules. GSK is currently evaluating ispinesib in two Phase II
clinical trials being conducted in patients with each of ovarian and breast
cancers and two Phase Ib clinical trials designed to evaluate ispinesib in
combination with each of carboplatin and capecitabine.
In addition to the ongoing studies being conducted by GSK and the
RMHNSC study reported today, the NCI is conducting four other Phase II
clinical trials evaluating ispinesib in other tumor types, including
hepatocellular, prostate, and renal cell cancers and in melanoma. The NCI
is also conducting two other Phase I clinical trials evaluating a new
schedule of ispinesib, one in leukemia and another in advanced solid
tumors, and is expected to initiate a Phase I clinical trial evaluating
ispinesib as monotherapy in pediatric patients with relapsed or refractory
solid tumors in the second half of 2006.
About SB-743921
SB-743921, Cytokinetics' second KSP inhibitor to enter clinical trials
under the strategic alliance with GSK, is structurally distinct from
ispinesib, Cytokinetics' most advanced drug candidate. In September 2005,
Cytokinetics and GSK announced an amendment to their original collaboration
agreement to support further expansion of the development activities for
SB-743921. Under the terms of the amendment, Cytokinetics is responsible
for leading and funding development activities to explore the potential
application of SB-743921 for the treatment of non-Hodgkin's lymphoma (NHL),
Hodgkin's disease and multiple myeloma, subject to GSK's option to resume
responsibility for development and commercialization activities for
SB-743921 for these indications during a defined period. Cytokinetics'
development activities will be conducted in parallel with GSK's development
activities for SB-743921 in other indications and for ispinesib. In April
2006, Cytokinetics announced the initiation of a Phase I/II clinical trial
of SB-743921 in patients with NHL, in connection with an expanded
development program for SB-743921. This Phase I/II clinical trial is an
open-label, non-randomized study to investigate the safety, tolerability,
pharmacokinetic, and pharmacodynamic profile of SB-743921, administered as
a one-hour infusion on days 1 and 15 of a 28-day schedule, and to assess
the potential efficacy of the maximum tolerated dose of SB-743921
administered on this schedule in patients with NHL.
About Cytokinetics
Cytokinetics is a biopharmaceutical company focused on the discovery,
development and commercialization of novel small molecule drugs that
specifically target the cytoskeleton. The cytoskeleton is a complex
biological infrastructure that plays a fundamental role within every human
cell. Cytokinetics' focus on the cytoskeleton enables it to develop novel
and potentially safer and more effective classes of drugs directed at
treatments for cancer, cardiovascular disease and other diseases. Under a
strategic alliance established in 2001, Cytokinetics and GSK are
collaborating to develop and commercialize small molecule therapeutics
targeting human mitotic kinesins for applications in the treatment of
cancer and other diseases. Ispinesib (SB-715992), SB-743921 and GSK-923295
are being developed under the strategic alliance with GSK. GSK is
conducting Phase II and Ib clinical trials for ispinesib and Cytokinetics
is conducting a Phase I/II trial of SB-743921 in non-Hodgkin's lymphoma.
Cytokinetics' unpartnered cardiovascular disease program is the second
program to leverage the company's expertise in cytoskeletal pharmacology.
Cytokinetics recently completed a Phase I clinical trial with CK-1827452, a
novel small molecule cardiac myosin activator, for the intravenous
treatment of heart failure and also is advancing CK-1827452 as a potential
drug candidate for the treatment of chronic heart failure via oral
administration. Additional information about Cytokinetics can be obtained
at http://www.cytokinetics.com .
This press release contains forward-looking statements for purposes of
the Private Securities Litigation Reform Act of 1995 (the "Act").
Cytokinetics disclaims any intent or obligation to update these
forward-looking statements, and claims the protection of the Safe Harbor
for forward-looking statements contained in the Act. Examples of such
statements include, but are not limited to, statements relating to
Cytokinetics and its partners' clinical research and development programs,
including expected future clinical trials, the potential benefits of
Cytokinetics' drug candidates and potential drug candidates and the
enabling capabilities of Cytokinetics' proprietary technologies. Such
statements are based on management's current expectations, but actual
results may differ materially due to various factors. Such statements
involve risks and uncertainties, including, but not limited to, those risks
and uncertainties relating to decisions by the NCI to postpone or
discontinue development efforts for one or more compounds, difficulties or
delays in patient enrollment for clinical trials, unexpected adverse side
effects or inadequate therapeutic efficacy of Cytokinetics' drug candidates
and other potential difficulties or delays in development, testing,
regulatory approval, production and marketing of Cytokinetics' drug
candidates that could slow or prevent clinical development or product
approval (including the risks relating to uncertainty of patent protection
for Cytokinetics' intellectual property or trade secrets and Cytokinetics'
ability to obtain additional financing if necessary and unanticipated
research and development and other costs), the conduct of activities and
continued funding under Cytokinetics' collaborations and the implementation
and maintenance of procedures, policies, resources and infrastructure
relating to compliance with new or changing laws, regulations and
practices. For further information regarding these and other risks related
to Cytokinetics' business, investors should consult Cytokinetics' filings
with the Securities and Exchange Commission.
Cytokinetics, Incorporated
http://www.cytokinetics.com
Cytokinetics Rapoarte de date pentru Ispinesib În recurente ºi / sau metastatic capului ºi gâtului Squamous Cell carcinomul - Cytokinetics Reports Data For Ispinesib In Recurrent And/or Metastatic Head And Neck Squamous Cell Carcinoma - articole medicale engleza - startsanatate