LONDON and CAMBRIDGE, MA -- 11/10/09 --
Antisoma plc (LSE: ASM; USOTC: ATSMY) holds its AGM today and provides an update, which
also serves as the Company's Interim Management Statement for the
period from 1 July 2009 to 9 November 2009.
Antisoma's CEO Glyn Edwards, said: "We are finishing 2009 in a strong
position, with two drugs well into pivotal phase III trials and
significant cash resources. We are focused on completing key studies
of our late-stage drugs and preparing for their commercialisation,
while also continuing to explore opportunities to add new assets to
our business."
ASA404 - a potential blockbuster
ASA404, our Tumour-Vascular Disrupting Agent, continues to make good
progress in the capable hands of our partner, Novartis. In September,
we announced that the ATTRACT-1 phase III trial had completed patient
enrolment. This 1200-patient study is evaluating ASA404 in
combination with standard chemotherapy as a first-line treatment for
non-small cell lung cancer. We expect data from the trial in late
2010 or early 2011, with applications for marketing to follow during
2011 if the data are positive.
Novartis is also conducting ATTRACT-2, a 900-patient phase III trial
testing ASA404 as a second-line treatment for non-small cell lung
cancer. Testing the drug in both the first- and second-line settings
will ensure that a broad spectrum of lung cancer patients could be
eligible for treatment with the drug.
Novartis also intends to develop ASA404 in another major indication,
HER2-negative metastatic breast cancer. More details of the plans for
this indication will be available in the near future.
Antisoma has the option to co-commercialise ASA404 with Novartis in
the US, which fits with Antisoma's plans to become directly involved
in the commercialisation of its products. The deal with Novartis
could yield substantial milestone payments based on the progress of
ASA404 as well as royalties on all sales of the drug worldwide.
AS1413 - second key phase III product
AS1413 is a novel chemotherapy drug with promising potential as a
treatment for blood cancers. A key property of AS1413 is its ability
to evade a variety of multi-drug resistance mechanisms, such as Pgp,
MRP-1 and BCRP. These are molecular pumps used by cancer cells to
expel drugs, including some of the major chemotherapies in use today.
By evading these mechanisms, AS1413 has the potential to work in
settings where other treatments provide limited benefit.
We are developing AS1413 initially as a treatment for secondary acute
myeloid leukaemia (secondary AML), a form of AML that evolves from
prior bone marrow disease or develops following radiotherapy or
chemotherapy for other cancers. Patients with secondary AML often
have multi-drug resistant disease and there are no drugs approved
specifically for this condition.
We are enrolling patients into a pivotal, randomised phase III trial
of AS1413 in secondary AML. This trial, called ACCEDE, compares
AS1413 plus cytarabine with daunorubicin plus cytarabine, the most
common initial treatment for AML. The ACCEDE study builds on positive
data from previous studies: from a phase I trial, just published in
Leukemia Research, which highlighted the drug's potential in this
setting, and from a phase II trial that evaluated the drug in 88
patients with secondary AML. Final follow-up data from the phase II
trial will be presented at this year's ASH meeting in December.
Results from the ACCEDE trial are expected to be available in late
2010 or early 2011. Should these be positive, we plan to market the
drug ourselves in the US while seeking partners for marketing in
other territories. We believe that AS1413 could achieve worldwide
sales running into hundreds of millions of dollars as a treatment for
secondary AML, and that there is also a wider opportunity for the
drug in other blood cancer settings.
AS1411 - significant developments ahead
Earlier this year we presented positive data from a phase II trial of
our aptamer drug, AS1411, in AML. The addition of 10 or 40 mg/kg/day
AS1411 to cytarabine chemotherapy increased the response rate without
significantly increasing side-effects. We now plan to build on these
findings by conducting a phase IIb trial, which is expected to begin
early next year.
The new trial will include around 90 patients in three treatment
groups: a control group will get chemotherapy alone while two
combination groups receive AS1411 together with chemotherapy. AS1411
will be given at 40 or 80 mg/kg/day, so the highest dose tested will
be twice that used in the previous trial. The dose of cytarabine
chemotherapy will also be slightly higher than that used previously.
In addition, the patient population will be refined: the prior trial
included patients who had proved unresponsive (refractory) to
previous therapy or who had suffered up to three relapses, whereas
the new trial will only include patients in first relapse or
refractory to one previous treatment. The phase IIb trial will
capture the initial response to treatment, how long patients remain
disease-free and how long they survive following treatment. The goal
is to provide a data-set that allows us to make optimal plans for a
registration study.
In parallel with the programme in AML, we have been running a
single-arm phase II trial in renal cancer. This completed patient
enrolment in May, and is expected to report initial data before the
end of 2009.
As with AS1413, Antisoma currently retains all marketing and
commercialisation rights to AS1411. We plan to continue development
through late-stage trials and to commercialise the product ourselves
in the US while seeking partners for other territories.
Strong financial position
We reported in our year-end financial results that we had GBP 67.0
million at the end of June 2009, and indicated that these funds were
sufficient to support all our priority programmes until mid-2011,
beyond the time when data are expected from the key phase III studies
of ASA404 and AS1413.
Outlook
Before the end of this year, we expect the first data from our phase
II trial of AS1411 in renal cancer and additional details of
Novartis' plans for developing ASA404 in breast cancer. We are moving
forward with our plans to transition from a company focused on
developing cancer drugs into one that can also successfully
commercialise them. While our principal focus is the completion of
phase III trials on ASA404 and AS1413, we also continue to advance
the earlier stage products in our portfolio and to explore
opportunities to add new drugs to the pipeline.
Enquiries:
Antisoma plc +44 (0)203 249 2100/ + 44
(0) 7909 915068
Glyn Edwards, Chief Executive Officer
Daniel Elger, VP, Marketing &
Communications
Alison Saville, Senior Marketing &
Communications Executive
Buchanan Communications +44 (0)20 7466 5000
(All media enquiries)
Mark Court, Lisa Baderoon, Catherine Breen
The Trout Group +1 617 583 1308
(US investor enquiries)
Seth Lewis
Except for the historical information presented, certain matters
discussed in this statement 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 Group'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.
Background on Antisoma
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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