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Everolimus (RAD001) Significantly Extends Progression-Free Survival In Advanced Kidney Cancer Patients After Failure Of Other Targeted Therapy
An independent
data monitoring committee stopped a major Phase III clinical trial of the
investigational drug everolimus (RAD001) after interim results showed
significantly better progression-free survival in patients with advanced
kidney cancer who received everolimus compared to placebo.
The committee stopped the trial of more than 400 patients conducted in
12 countries because the study met its primary endpoint. The interim
findings are being shared with investigators to allow them to offer
everolimus to patients remaining on placebo. Everolimus may fulfill an
unmet medical need for patients with advanced renal cell cancer (RCC) who
currently have no approved treatment options.
Everolimus is a once-daily oral therapy that offers a new approach to
cancer treatment by inhibiting the mTOR protein, a central regulator of
tumor cell division and blood vessel growth in cancer cells. The trial
included patients who had their cancer worsen despite receiving approved
treatments for RCC, such as Nexavar(R) (sorafenib)(1) or Sutent(R)
(sunitinib)(2) or both. In addition, prior therapy with Avastin(R)
(bevacizumab)(3) and interferon was allowed.
"Everolimus has the potential to greatly help patients with kidney
cancer, especially in advanced stage who up to now have had no treatment
options, as patients in the clinical trial on everolimus experienced a
significantly longer period of time during which their cancer did not
progress," said Daniel Vasella, Chairman and CEO of Novartis. "Everolimus
is a targeted therapy which is being studied in multiple tumor types, and
could provide significant benefit to patients suffering from cancer."
"This progression-free survival benefit demonstrates the possibilities
of continuous mTOR inhibition as a promising target in oncology," said
David Epstein, President and CEO, Novartis Oncology. "These data are the
first from a broad clinical research program that includes studies in
patients with high unmet needs suffering from a variety of cancers.
Everolimus is the first compound in our dynamic oncology late-stage
pipeline with six compounds in registration trials to show exciting
clinical data this year."
Complete results of the RECORD-1 (REnal Cell cancer treatment with Oral
RAD001 given Daily) trial will be submitted as a late-breaking abstract for
presentation at the American Society of Clinical Oncology annual meeting in
May. Worldwide regulatory filings for this indication beginning with US and
EU will occur in the second half of 2008.
RECORD-1 is the largest Phase III trial to investigate the potential of
the oral mTOR inhibitor everolimus as a treatment option for patients with
metastatic RCC who have failed prior targeted therapy. The randomized,
double- blind multi-center Phase III study compared everolimus to placebo.
Patients in the study were randomized according to Memorial Sloan-
Kettering Cancer Center (MSKCC) risk criteria and prior anti-cancer
therapy. MSKCC risk criteria are standard clinical criteria to determine
the prognosis of patients with RCC.
In addition to RCC, everolimus is presently being evaluated in
neuroendocrine tumors, lymphoma, other cancers, and tuberous sclerosis as a
single agent or in combination with existing cancer therapies.
Safety findings in the study were manageable and consistent with prior
Phase II studies. Common adverse events in the study included mouth ulcers,
high blood lipids, high blood sugar, skin rash, low red blood count, low
phosphate levels, and inflammation of the lungs.
About Everolimus
Everolimus, an oral inhibitor of mTOR, is an investigational drug being
studied in multiple tumor types. In cancer cells, everolimus inhibits mTOR,
a protein that acts as a central regulator of tumor cell division, cell
metabolism and blood vessel growth. Everolimus is a once-daily oral therapy
that provides continuous inhibition of mTOR.
As an investigational compound, the safety and efficacy profile of
everolimus has not yet been established in oncology. Access to everolimus
is available only through carefully controlled and monitored clinical
trials. These trials are designed to better understand the potential
benefits and risks of the compound. Because of the uncertainty of clinical
trials, there is no guarantee that everolimus will ever be commercially
available for oncology indications anywhere in the world. Everolimus is
approved under the trade-name Certican(R) for the prevention of organ
rejection in heart and kidney transplant recipients. Certican was first
approved in the EU in 2003 and is available in more than 60 countries.
Disclaimer
The foregoing release contains forward-looking statements that can be
identified by terminology such as "to be", "planned", "may", "offers",
"potential", "could", "possibilities", "will", or similar expressions, or
by express or implied discussions regarding potential future approvals for
everolimus or regarding potential future revenues from everolimus. Such
forward-looking statements reflect the current views of the Company
regarding future events, and involve known and unknown risks, uncertainties
and other factors that may cause actual results with everolimus to be
materially different from any future results, performance or achievements
expressed or implied by such statements. There can be no guarantee that
everolimus will be approved for any oncology indications. Nor can there be
any guarantee that everolimus will achieve any particular levels of revenue
in the future. In particular, management's expectations regarding
everolimus could be affected by, among other things, unexpected clinical
trial results, including unexpected new clinical data and unexpected
additional analysis of existing clinical data; unexpected regulatory
actions or delays or government regulation generally; the company's ability
to obtain or maintain patent or other proprietary intellectual property
protection; competition in general; government, industry and general public
pricing pressures, and other risks and factors referred to in Novartis AG's
current Form 20-F on file with the US Securities and Exchange Commission.
Should one or more of these risks or uncertainties materialize, or should
underlying assumptions prove incorrect, actual results may vary materially
from those anticipated, believed, estimated or expected. Novartis is
providing the information in this press release as of this date and does
not undertake any obligation to update any forward-looking statements
contained in this press release as a result of new information, future
events or otherwise.
About Novartis
Novartis Pharmaceuticals Corporation researches, develops, manufactures
and markets leading innovative prescription drugs used to treat a number of
diseases and conditions, including those in the cardiovascular, metabolic,
cancer, organ transplantation, central nervous system, dermatological,
gastrointestinal and respiratory areas. The company's mission is to improve
people's lives by pioneering novel healthcare solutions.
Located in East Hanover, New Jersey, Novartis Pharmaceuticals
Corporation is an affiliate of Novartis AG (NYSE: NVS), a world leader in
offering medicines to protect health, cure disease and improve well-being.
Our goal is to discover, develop and successfully market innovative
products to treat patients, ease suffering and enhance the quality of life.
We are strengthening our medicine-based portfolio, which is focused on
strategic growth platforms in innovation-driven pharmaceuticals,
high-quality and low-cost generics, human vaccines and leading
self-medication OTC brands. Novartis is the only company with leadership
positions in these areas. In 2006, the Group's businesses achieved net
sales of USD 37.0 billion and net income of USD 7.2 billion. Approximately
USD 5.4 billion was invested in R&D. Headquartered in Basel, Switzerland,
Novartis Group companies employ approximately 100,000 associates and
operate in over 140 countries around the world. For more information,
please visit http://www.pharma.us.novartis.com.
References
1 Nexavar is a registered trademark of Bayer.
2 Sutent is a registered trademark of Pfizer.
3 Avastin is a registered trademark of Genentech.
Novartis Pharmaceuticals Corporation
http://www.pharma.us.novartis.com
View drug information on Avastin; Nexavar; Sutent.
Everolimus (RAD001) se extinde în mod semnificativ supravieþuirea fãrã progresia bolii la pacienþii cu cancer renal avansat, dupã eºecul terapiei de alte orientate - Everolimus (RAD001) Significantly Extends Progression-Free Survival In Advanced Kidney Cancer Patients After Failure Of Other Targeted Therapy - articole medicale engleza - startsanatate