1 September 2009, London, UK, and Cambridge, MA: Antisoma plc (LSE:
ASM; USOTC: ATSMY) today announces that the ATTRACT-1 phase III trial
of ASA404 in non-small cell lung cancer (NSCLC) has reached its
enrolment target of 1,200 patients. The trial is the single pivotal
registration study for the drug as a first-line treatment for
squamous and non-squamous NSCLC, and is being conducted by Novartis,
Antisoma's development and commercialisation partner for ASA404.
Glyn Edwards, Antisoma's CEO, said: "Novartis has done an excellent
job in rapidly completing recruitment into this very large trial of
ASA404 in lung cancer. We can now be even more confident that the
results will be available in time to support potential marketing
applications in 2011."
Primo N. Lara, Professor of Medicine at the University of California
Davis Cancer Center and U.S. Steering Committee Chair for the
ATTRACT-1 study, said: "Lung cancer afflicts an enormous number of
patients worldwide and there is a clear need for new and improved
treatment options. Phase II trials reported substantial benefits for
lung cancer patients receiving ASA404, and I therefore look forward
greatly to seeing the results of this large and important phase III
ASA404 is a Tumour-Vascular Disrupting Agent (Tumour-VDA) that
selectively disrupts established tumour vasculature, inhibits tumour
blood flow, and causes extensive tumour necrosis.
Daniel Elger, VP Marketing & Communications +44 (0)7909 915 068
Mark Court/Lisa Baderoon/Rebecca Skye Dietrich +44 (0)20 7466 5000
Brian Korb +1 646 378 2923
The Trout Group
Except for the historical information presented, certain matters
discussed in this announcement are forward looking statements that
are subject to a number of risks and uncertainties that could cause
actual results to differ materially from results, performance or
achievements expressed or implied by such statements. These risks and
uncertainties may be associated with product discovery and
development, including statements regarding the company's clinical
development programmes, the expected timing of clinical trials and
regulatory filings. Such statements are based on management's current
expectations, but actual results may differ materially.
About the ATTRACT-1 study
ATTRACT-1 is a pivotal study designed to support applications to
market ASA404 in previously untreated, advanced NSCLC. It is a
randomised, double-blind, placebo-controlled, multicentre phase III
trial being conducted across the US, EU, Japan and other territories.
ATTRACT-1 opened in April 2008 and has enrolled patients with all
histologies, or types, of NSCLC, including squamous and non-squamous
cancers. Patients have been randomised 1:1 to receive either ASA404
plus chemotherapy (carboplatin/paclitaxel) or a placebo plus
chemotherapy (carboplatin/paclitaxel) as a control.
The primary endpoint of ATTRACT-1 is overall survival. Key secondary
endpoints are survival in the squamous and non-squamous patient
subgroups. An interim look is expected to be triggered before the end
of 2009. Following collation and processing of data, the interim look
will take place in early 2010. The outcome will be announced
immediately. The most likely outcome is that the study will continue
to completion. No data will be released unless the look indicates
that the trial should stop because of clear futility or early
evidence of overwhelming efficacy. Full and final data are expected
to be available in late 2010 or early 2011, in time to support
potential applications to market the drug in 2011.
In addition to the ATTRACT-1 trial in previously untreated NSCLC
patients, Novartis is conducting a separate pivotal study, ATTRACT-2,
to evaluate ASA404 in NSCLC patients who have received one previous
About non-small cell lung cancer (NSCLC)
Lung cancer is the biggest cause of cancer death for both men and
women worldwide, with 1.2 million new cases per year and around
920,000 deaths. Around 85-90% of all lung cancer cases are NSCLC.
ASA404 (vadimezan, formerly known as DMXAA and AS1404) is a
small-molecule Tumour-Vascular Disrupting Agent (Tumour-VDA) which
targets the blood vessels that nourish tumours. The drug was
discovered by Professors Bruce Baguley and William Denny and their
teams at the Auckland Cancer Society Research Centre, University of
Auckland, New Zealand. It was in-licensed by Antisoma from Cancer
Research Ventures Limited (now Cancer Research Technology), the
development and commercialisation company of the Cancer Research
Campaign (now Cancer Research UK), in 2001. Worldwide rights to the
drug were licensed to Novartis AG in April 2007; Antisoma has an
option to co-sell ASA404 with Novartis in the United States. Novartis
is conducting phase III studies of ASA404 in NSCLC, and also plans to
investigate the drug's potential as a treatment for metastatic breast
A randomised phase II trial in patients receiving first-line
treatment for NSCLC showed that addition of ASA404 to carboplatin and
paclitaxel chemotherapy improved survival by 5 months. A second,
single-arm, phase II trial also reported positive results with ASA404
in the same patient group.
Antisoma is a London Stock Exchange-listed biopharmaceutical company
that develops novel products for the treatment of cancer. The Company
has operations in the UK and the US. Please visit
www.antisoma.com for further information about Antisoma.
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