 |
|
 |
 |
|
ASA404, a novel cancer agent, begins pivotal trial to explore new
approach in treating lung cancer, the leading cause of cancer death |
|
Corporate news announcement processed and transmitted by Hugin ASA.
The issuer is solely responsible for the content of this
announcement.
----------------------------------------------------------------------
--------------
* With launch of Phase III ATTRACT-1 trial in non-small cell lung
cancer, Novartis Oncology assumes responsibility for development
of ASA404 from Antisoma
* Novel mechanism of action of ASA404 disrupts existing blood
supply to tumors
* Tumor-Vascular Disrupting Agent is one of six Novartis Oncology
compounds in late-stage development for various solid tumors and
blood cancers
* With launch of Phase III ATTRACT-1 trial in non-small cell lung
cancer, Novartis Oncology assumes responsibility for development
of ASA404 from Antisoma
* Novel mechanism of action of ASA404 disrupts existing blood
supply to tumors
* Tumor-Vascular Disrupting Agent is one of six Novartis Oncology
compounds in late-stage development for various solid tumors and
blood cancers
Basel, April 11, 2008 - Novartis announced today that ASA404, its
novel cancer agent, has entered a Phase III lung cancer trial
following positive outcomes of a Phase II trial. The novel mechanism
of action of ASA404 may represent a new approach to treating the most
prevalent cause of cancer death.
ASA404 is a Tumor-Vascular Disrupting Agent (Tumor-VDA) that
selectively causes the collapse of existing tumor blood supply
leading to extensive tumor cell death. The action of ASA404 is
distinct from that of angiogenesis inhibitors, which inhibit the
formation of new tumor blood vessels.
In a randomized Phase II study, ASA404, in combination with
chemotherapy, demonstrated a median overall survival advantage of
more than five months in first-line treatment of advanced non-small
cell lung cancer (NSCLC) compared with chemotherapy alone. A similar
survival advantage was observed in a subsequent extension of the
Phase II study.
Non-small cell lung cancer, the potential lead indication for ASA404,
accounts for about 85% to 90% of all lung cancers. Worldwide, lung
cancer is the number one cause of death from cancer each year in both
men and women, with 1.2 million new cases per year and 921,000
deaths.
"With the launch of ATTRACT-1, we look forward to exploring the
unique mechanism of action of ASA404 in non-small cell lung cancer to
potentially help the more than one million people who develop lung
cancer each year," said Alessandro Riva, Executive Vice President and
Global Head of Development of Novartis Oncology.
ASA404 is one of six novel oncology compounds Novartis is developing
for potential registration over the next five years. The other
investigational therapies which focus on a broad array of cancer
targets include RAD001 (renal cell carcinoma and other cancers),
SOM230 (Cushing's disease/refractory carcinoid tumors, acromegaly),
LBH589 (cutaneous T-cell lymphoma and other cancers), EPO906 (ovarian
cancer), and PKC412 (acute myelogenous leukemia and aggressive
systemic mastocytosis).
"Today, our broad and deep pipeline includes both small molecules and
monoclonal antibodies that utilize a variety of mechanisms such as
vascular-disruption, anti-angiogenesis, and kinase inhibition to
treat cancer," said David Epstein, President and CEO of Novartis
Oncology. "These exciting potential discoveries have the possibility
to change medical treatment for patients suffering with many forms of
cancer."
About ATTRACT-1
ATTRACT-1 (Antivascular Targeted Therapy: Researching ASA404 in
Cancer Treatment) is a Phase III clinical trial that will be
conducted at more than 200 sites in 20 countries.
The trial will be a randomized, double-blind, placebo-controlled,
multi-center study of ASA404 in combination with paclitaxel and
carboplatin as first-line treatment for locally advanced or
metastatic (Stage IIIb/IV) NSCLC of squamous or nonsquamous
histology. The trial will consist of 1,200 patients who will be
assigned to one of the following treatment arms in a ratio of 1:1:
ASA404 1800 mg/m2 plus chemotherapy (carboplatin/paclitaxel) or
placebo plus chemotherapy (carboplatin/paclitaxel) as a control.
Treatment will be given for up to six cycles, with one cycle equaling
21 days and total treatment equaling 126 days (4.2 months).
ASA404
ASA404 is a small-molecule Tumor-VDA that selectively disrupts
existing tumor blood vessels. Solid tumors rely on a network of blood
vessels to survive and grow. ASA404 targets existing tumor blood
vessels causing death of vessel endothelial cells and the collapse of
tumoral blood vessels.
Novartis signed an exclusive licensing agreement with Antisoma plc
for the worldwide rights to ASA404 in April 2007.
Because it is an investigational compound, the safety and efficacy
profile of ASA404 has not yet been established. Access to this
investigational compound 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 uncertainty of clinical trials, there is no
guarantee that ASA404 will ever be commercially available anywhere in
the world.
Disclaimer
The foregoing release contains forward-looking statements that can be
identified by terminology such as "to explore," "may," "look
forward," "potential," "possibility," "will," or similar expressions,
or by express or implied discussions regarding potential future
approvals to market ASA404 or regarding potential future revenues
from ASA404. 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 ASA404 to be materially different from any future
results, performance, or achievements expressed or implied by such
statements. There can be no guarantee that ASA404 will be approved
for sale in any market. Nor can there be any guarantee that ASA404
will achieve any particular levels of revenue in the future. In
particular, management's expectations regarding ASA404 could be
affected by, among other things, unexpected regulatory actions or
delays or government regulation generally; unexpected clinical trial
results, including unexpected new clinical data and unexpected
additional analysis of existing clinical data; 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 AG provides healthcare solutions that address the evolving
needs of patients and societies. Focused solely on growth areas in
healthcare, Novartis offers a diversified portfolio to best meet
these needs: innovative medicines, cost-saving generic
pharmaceuticals, preventive vaccines and diagnostic tools, and
consumer health products. Novartis is the only company with leading
positions in these areas. In 2007, the Group's continuing operations
(excluding divestments in 2007) achieved net sales of USD 38.1
billion and net income of USD 6.5 billion. Approximately USD 6.4
billion was invested in R&D activities throughout the Group.
Headquartered in Basel, Switzerland, Novartis Group companies employ
approximately 98,200 full-time associates and operate in over 140
countries around the world. For more information, please visit
http://www.novartis.com
# # #
Novartis Media Relations
Beatrix Benz Geoff Cook
Novartis Global Media Novartis Oncology Communications
Relations +1 862 778 2675 (direct)
+41 61 324 7999 (direct) +1 973 652 7927 (mobile)
+41 79 618 7748 (mobile) geoffrey.cook@novartis.com
beatrix.benz@novartis.com
Novartis Investor Relations
Ruth +41 61 324 9980
Metzler-Arnold
Katharina Ambuehl +41 61 324 North America
5316 Office
Pierre-Michel +41 61 324 1065 Richard Jarvis +1 212 830
Bringer 2433
John Gilardi +41 61 324 3018 Jill Pozarek +1 212 830
2445
Jason Hannon +41 61 324 2152 Edwin Valeriano +1 212 830
2456
Thomas +41 61 324 8425
Hungerbuehler
Isabella Zinck +41 61 324 4353
Central phone no: +41 61 324 7944
Fax no: +41 61 324 8444 Fax no: +1 212 830
2405
e-mail: e-mail:
investor.relations@novartis.com investor.relations@novartis.com
--- End of Message ---
Novartis International AG
Posfach Basel
WKN: 904278; ISIN:
CH0012005267; Index: SLCI, SMI, SPI, SLIFE;
Listed: Main Market in SWX Swiss Exchange, ZLS in BX Berne eXchange;
|
|
|
|
| |
 |
durchschnittliche Punktzahl: 0 Stimmen: 0
| |
 |
|
|
 |  |