califax
14 years ago
Antisoma's phase III trial of AS1413 completes patient enrolment
Date : 09/08/2010 @ 2:00AM
Source : UK Regulatory (RNS & others)
Stock : Antisoma (ASM)
http://ih.advfn.com/p.php?pid=nmona&article=44279511&symbol=L^ASM
London, UK, and Cambridge, MA: 8 September 2010 - Cancer drug developer Antisoma
plc (LSE: ASM; USOTC: ATSMY) announces that the ACCEDE phase III trial of AS1413
(amonafide L-malate) in secondary acute myeloid leukaemia (secondary AML) is now
fully enrolled. Data from the trial are expected in the first half of 2011, with
filings for marketing authorisations to follow if these are positive.
ACCEDE is a single pivotal, randomised, controlled trial in which a regimen of
AS1413 and cytarabine is compared with standard AML remission-induction therapy
of daunorubicin and cytarabine ('7+3'). The primary endpoint of the study is the
rate of complete remission with or without recovery of normal blood counts.
Recruitment into the study has been rapid, especially over the past year.
Over 420 patients from 22 countries have been included, making it the largest
prospective trial ever conducted in patients with secondary AML.
Secondary AML is a significant subgroup of AML that develops from prior
myelodysplastic syndrome (MDS) or follows treatment of another cancer with
chemotherapy or radiotherapy. The disease is often multi-drug resistant and
responds poorly to currently available therapies. A key feature of AS1413, and a
potential advantage over many current AML treatments, is the drug's ability to
evade multi-drug resistance mechanisms.
Professor Richard Stone, MD, Director of the Adult Leukemia Program at the
Dana-Farber Cancer Institute, Boston, and one of the leading investigators in
the AS1413 phase III trial, said: "There is a great need for new treatment
options for patients with poor-risk AML, such as the secondary AML patients
included in the ACCEDE trial. It will be fascinating to see if AS1413 can
deliver on the promise suggested by earlier studies."
Glyn Edwards, CEO of Antisoma, said: "Completion of enrolment in the phase III
trial is a critical milestone in the development of AS1413, and puts us on track
to see the outcome in the near future. I would like to thank all the patients
and physicians who have joined with us in seeking to improve the treatment of
secondary AML."
AS1413 has orphan drug status in both the U.S. and the E.U. for the treatment of
AML and recently received Fast Track status from the U.S. FDA for the treatment
of secondary AML.
Enquiries:
Glyn Edwards, CEO
Daniel Elger, VP Marketing & Communications +44 (0)20 3249 2100
Antisoma plc
Mark Court/Lisa Baderoon/Catherine Breen +44 (0)20 7466 5000
Buchanan Communications
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 AS1413 (amonafide L-malate)
AS1413 (amonafide L-malate) was added to Antisoma's pipeline through the
acquisition of Xanthus Pharmaceuticals, Inc. in June 2008. AS1413 is a novel DNA
intercalator that induces apoptotic signalling by blocking topoisomerase II
binding to DNA. This differs from the action of classical topoisomerase II
inhibitors, which induce apoptosis by causing extensive DNA damage. A further
distinctive feature of AS1413 is its ability to evade Pgp and related
transporters responsible for multi-drug resistance (MDR).
A pivotal phase III trial (ACCEDE) is evaluating AS1413 as a treatment for
secondary AML, a condition often associated with MDR and in which outcomes with
currently available treatments are poor. The trial was designed to screen 450
patients in order to enrol 420 eligible patients. Enrolment is now completed.
Data are expected in the first half of 2011 after all patients have completed
treatment under the trial protocol and findings have been collated and analysed.
An earlier phase II trial showed a complete remission rate of 39% in patients
with secondary AML, a finding that compares favourably with data from two
previous co-operative group studies in which similar patients were treated with
standard anthracycline plus cytarabine regimens.
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 U.K. and the U.S. Please visitwww.antisoma.com for further information
about Antisoma.
[HUG#1443027]
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Antisoma plc via Thomson Reuters ONE
califax
14 years ago
Antisoma's preliminary results for the year ended 30 June 2010
Date : 07/29/2010 @ 2:01AM
Source : UK Regulatory (RNS & others)
Stock : Antisoma (ASM)
http://ih.advfn.com/p.php?pid=nmona&article=43787366&symbol=L^ASM
London, UK, and Cambridge, MA: 29 July 2010 Antisoma plc (LSE: ASM; USOTC:
ATSMY) today announces its preliminary results for the year ended 30 June 2010.
These results have been prepared under International Financial Reporting
Standards ('IFRS') as adopted for use by the European Union.
Key events of 2009/2010
AS1413
* Positive final data reported from secondary AML phase II trial
* Secondary AML phase III trial over 75% enrolled
* FDA Fast Track status awarded
* Phase III data expected H1 2011
AS1411
* Positive long-term follow-up data from phase II AML trial
* Renal cancer phase II trial shows further evidence of activity
* New non-clinical data indicate potential in major cancer types
* Orphan drug status for AML obtained in US and EU
* Phase IIb trial in AML ongoing; headline data expected H1 2011
ASA404
* Front-line lung cancer phase III trial discontinued for futility
Financial highlights
* Cash at 30 June 2010 of GBP 32.1 million (30 June 2009: GBP 67.0 million)
* Cash life extends well beyond key phase III results
* Revenues of GBP 20.3 million (2009: GBP 25.2 million)
* Reflects half of the USD 60 million up-front payment from sanofi-aventis
(GBP 19.7 million) for the divestment of oral fludarabine
* Full year loss of GBP 18.7 million (2009: loss of GBP 16.4 million)
Commenting on the results, Glyn Edwards, CEO of Antisoma, said: "We have two
promising cancer drugs, AS1413 and AS1411, both of which we expect to report key
trial data by mid-2011, and cash resources to take us well past these data."
A webcast and conference call will be held today at 10.30 am BST. The webcast
can be accessed via Antisoma's website at
http://www.antisoma.com/asm/media/webcast/ and the call by dialling +44 (0)
207 806 1964 (US toll-free +1 718 354 1390) and using the Confirmation Code:
9656482. A recording of the webcast will also be available afterwards on the
Antisoma website.
Enquiries:
Antisoma plc +44 (0)7909 915 068
Glyn Edwards, Chief Executive Officer
Eric Dodd, Chief Financial Officer
Daniel Elger, VP, Marketing & Communications
Buchanan Communications +44 (0)20 7466 5000
Mark Court, Lisa Baderoon, Catherine Breen
Except for the historical information presented, certain matters described 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 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.
Joint Chief Executive and Chairman's statement
Overview
We have had a challenging year, including a disappointment in March, when a
phase III trial evaluating ASA404 as a first-line treatment for lung cancer was
discontinued for futility. We recognise that ASA404 was considered the Company's
most significant asset, but we are fortunate in having another late-stage cancer
drug, AS1413, with substantial market potential. Addressing an indication in
acute leukaemia where there is high unmet need, poor satisfaction with currently
available generic therapies and clear potential for post-launch growth, AS1413
could readily achieve peak sales comparable in scale to the royalties that we
might have obtained through our alliance on ASA404. We expect data from the
phase III pivotal study of this compound in the first half of 2011.
AS1413 phase III trial nears enrolment target
AS1413 is a novel chemotherapy that we are testing in a large randomised phase
III trial in patients with secondary acute myeloid leukaemia (secondary AML).
The trial, known as ACCEDE, is approaching its enrolment target, which is to
screen 450 patients in order to provide 420 evaluable patients. Enrolment should
be completed in the third quarter of 2010 and we expect to announce results in
the first half of 2011.
During the year, we have presented new findings supporting AS1413 at major
scientific and medical meetings. In December, we reported positive final data
from a phase II trial of AS1413 in secondary AML at the American Society of
Hematology (ASH) Annual Meeting. We saw an encouraging number of longer-term
responders, with 30% of patients who achieved remission after treatment with
AS1413 still alive after 2 years. A presentation at the American Association of
Cancer Research (AACR) Annual Meeting in April reinforced the differentiation of
AS1413 from currently available leukaemia treatments and its potential to
provide unique benefits for patients. Presentations at the American Society of
Clinical Oncology (ASCO) Annual Meeting and the European Hematology Association
(EHA) Annual Meeting in June highlighted the importance of multi-drug resistance
as a barrier to successful treatment of AML. A key feature of AS1413 is its
ability to evade multi-drug resistance mechanisms.
In June we announced that the U.S. Food and Drug Administration (FDA) had
granted Fast Track designation to AS1413 for the treatment of secondary AML.
Fast-track designated drugs usually qualify for Priority Review, an expedited
review process available to drugs that offer major advances in treatment or
provide a treatment where no adequate therapy exists.
There is interest from potential partners in licensing AS1413. We have decided
to take a pragmatic stance to realising the value of the drug, and have
therefore widened our partnering discussions to include US rights, which we had
previously planned to retain. However, as we have the resources ourselves to
complete development of AS1413, we will only strike a deal ahead of the phase
III data if terms are sufficiently favourable.
We believe that AS1413 could ultimately find application in a number of blood
cancer settings, with potential sales running to hundreds of millions of dollars
annually.
AS1411 phase IIb trial ongoing
AS1411 is the most advanced aptamer in trials for cancer. In March we initiated
a 90-patient phase IIb study in patients with AML. This trial follows an earlier
60-patient randomised phase II trial in AML, in which use of AS1411 in
combination with cytarabine produced a higher remission rate than cytarabine
alone, without imposing any significant additional side-effects. At this year's
ASCO meeting, we presented long-term follow up data from the earlier study,
showing that five of the eight patients who responded to an AS1411-based
regimen, all of whom had advanced disease on entry to the study, had substantial
survival durations (from 12 to over 20 months). Headline data from the phase IIb
study are expected in the first half of 2011.
We continue to accumulate evidence that AS1411 has potential in a variety of
different cancers. Non-clinical data presented at AACR in April showed activity
in a model of colorectal cancer and positive findings when AS1411 was combined
with various approved treatments for blood cancers. At the ASCO meeting in June
we presented data from a 35-patient phase II study of AS1411 in advanced renal
cancer, which provided further evidence of activity in this setting.
In October we announced that AS1411 had been granted orphan drug status in the
US and the EU for the treatment of AML. These grants will provide seven years of
market exclusivity in the US and ten years of exclusivity in the EU if AS1411 is
approved as a treatment for AML.
DCAM auto-immune programme progressing towards partnering
We have an important pre-clinical programme in auto-immune diseases. This
comprises a series of molecules collectively known as DCAMs (dendritic cell
auto-immune modulators). They are highly specific, small-molecule inhibitors of
wild-type Flt3, and are designed for oral treatment of various auto-immune
conditions. Positive results have already been achieved in animal models of
inflammatory bowel disease and rheumatoid arthritis, and we are now working
towards establishing a licensing partnership for further development of the
programme.
Other pipeline developments
During the period, we discontinued development of a phase II product, AS1402,
divested a phase I product, P2045, to Bryan Oncor, and put on hold further
development of AS1409. We have also discontinued a number of preclinical
programmes as we focus our resources on development of our late-stage products,
AS1413 and AS1411.
Cash conservation measures enacted
We are no longer anticipating further revenues from the ASA404 programme, and
have therefore taken steps to reduce our cash utilisation and ensure that our
funds take us comfortably past key clinical data on AS1413 and AS1411, which are
expected during the first half of 2011. We finished the period with cash and
short-term deposits of GBP 32.1 million (2009: GBP 67.0 million).
Total revenues for the year ended 30 June 2010 were GBP 20.3 million, compared
with GBP 25.2 million last year. This year's revenues reflect half of the USD
60.0 million up-front payment from sanofi-aventis (GBP 19.7 million) for oral
fludarabine, which was deferred from the previous financial year, and the first
of five annual contingent payments due under the agreement.
Total operating expenses have increased from GBP 40.8 million last year to GBP
43.4 million this year, mainly reflecting an increase in general and
administrative costs, which were GBP 7.9 million (2009: GBP 4.9 million),
reflecting impairments made to intangible assets and lower foreign exchange
gains during the year. Research and development (R&D) costs were GBP 35.5
million (2009: GBP 35.9 million).
We have recorded a full-year loss of GBP 18.7 million (2009: GBP 16.4 million).
At this stage in our development, profits and losses reflect the balance between
recognition of deferred revenues and our ongoing operating expenses.
Board and management changes
Regrettably, we have had to restructure the business and make headcount
reductions as part of our effort to conserve cash resources. As part of the
restructuring, our former Chief Operating Officer, Dr Ursula Ney, left the
Company and the Antisoma Board in April. Ursula made a very significant
contribution to the development of Antisoma, and we wish her well with future
ventures. In June we closed our laboratories at BioPark in Hertfordshire,
leaving our operations concentrated at our headquarters in London and at our
Cambridge, MA, site and reducing our total headcount to around sixty.
Outlook
We believe we have the product assets, people and financial resources to build
value for the future. We look forward to a number of important clinical
milestones in the near term, notably phase III data on AS1413 and phase IIb data
on AS1411, both of which we expect in the first half of 2011.
Glyn Edwards
Chief Executive Officer
Barry Price
Chairman
califax
15 years ago
Antisoma announces AS1413 and AS1411 presentations at EHA
Date : 06/14/2010 @ 2:01AM
Source : UK Regulatory (RNS & others)
Stock : Antisoma (ASM)
http://ih.advfn.com/p.php?pid=nmona&article=43208588&symbol=L%5EASM
London, UK, Cambridge, MA, and Barcelona, Spain: 14 June 2010 - Cancer drug
developer Antisoma plc (LSE: ASM; USOTC: ATSMY) announces that five
presentations, including an oral presentation, supporting the development of
AS1413 (amonafide L-malate) and AS1411 were presented over the weekend at the
European Hematology Association (EHA) meeting in Barcelona. All are available on
Antisoma's website at http://www.antisoma.com <http://www.antisoma.com/>.
Details of the presentations can be found below.
Enquiries:
Antisoma plc:
Glyn Edwards, CEO
Daniel Elger, VP Marketing & Communications +44 (0)7909 915 068
Details of the presentations at EHA
AS1413
#0079 The presence of P-glycoprotein (MDR1) affects the ability of AML patients
to achieve complete remission; results of a meta-analysis of the literature;
Marie et al. (poster)
#0650 Treatment-related AML and AML evolving from MDS: Similar outcomes
following treatment with amonafide + cytarabine; Sekeres et al. (poster)
#0457 The novel DNA intercalator amonafide (AS1413) disrupts the cell cycle by
mechanisms distinct from those of Topo II inhibitors daunorubicin and etoposide;
Senderovich et al. (poster)
AS1411
#1119 Long-term outcomes of responders in a randomized, controlled phase II
trial of aptamer AS1411 in AML; Stuart et al. (oral presentation)
#0643 Gene expression analysis in AML cell line MV4-11 following treatment with
the anti-cancer aptamer AS1411 Senderovich et al. (poster)
About AS1413 (amonafide L-malate)
AS1413 (amonafide L-malate) was added to Antisoma's pipeline through the
acquisition of Xanthus Pharmaceuticals, Inc. in June 2008. AS1413 is a novel DNA
intercalator that induces apoptotic signalling by blocking topoisomerase II
binding to DNA. This differs from the action of classical topoisomerase II
inhibitors, which induce apoptosis by causing extensive DNA damage. A further
distinctive feature of AS1413 is its ability to evade Pgp and related
transporters responsible for multi-drug resistance (MDR). A pivotal phase III
trial (ACCEDE) is evaluating AS1413 as a treatment for secondary AML, a
condition often associated with MDR and in which outcomes with currently
available treatments are poor. Earlier this month, the US Food and Drug
Administration granted AS1413 Fast Track status for the treatment of secondary
AML.
About AS1411
AS1411 was originally developed by Dr Paula Bates, Dr John Trent and Prof.
Donald Miller at the University of Alabama and later at the University of
Louisville. Antisoma added AS1411 to its pipeline when it acquired the
Louisville-based company Aptamera Inc. in 2005. AS1411 belongs to a new type of
drugs called aptamers. These are short pieces of DNA or RNA that fold into
three-dimensional structures capable of targeting particular proteins. AS1411 is
a DNA aptamer that binds to nucleolin, a protein expressed in the nucleus of all
cells but which in cancer cells is also exposed on the cell surface, providing a
basis for specific targeting by AS1411. When AS1411 binds to nucleolin on cancer
cells, it is internalised and causes apoptosis through interference with various
functions of nucleolin. AS1411 is being evaluated in a phase IIb trial in
patients with relapsed and refractory AML.
About 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 visitwww.antisoma.com <http://www.antisoma.com/>
for further information about Antisoma.
califax
15 years ago
Antisoma announces presentation at ASCO of new data_supporting_AS1413_and_AS1411
05.06.2010 15:01
http://www.finanznachrichten.de/nachrichten-2010-06/17080059-antisoma-plc-antisoma-announces-presentation-at-asco-of-new-data-supporting-as1413-and-as1411-399.htm
Antisoma plc: Antisoma announces presentation at ASCO of new data supporting AS1413 and AS1411
London, UK, Cambridge, MA, and Chicago, IL: 5 June 2010 - Antisoma plc (LSE: ASM; USOTC: ATSMY) announces the presentation of new data supporting AS1413 and AS1411 at the American Society of Clinical Oncology (ASCO) Annual Meeting being held in Chicago from June 4-8.
Glyn Edwards, CEO of Antisoma, said: "We're delighted to share a wealth of new data on AS1413 and AS1411 at the ASCO meeting. Both drugs are approaching important milestones, with phase III data on AS1413 and phase IIb data on AS1411 due in the next 12 months. The latest findings provide further evidence of the unique potential of these novel approaches to cancer therapy."
Highlights of data presented:
· Meta-analysis of published acute myeloid leukemia (AML) trials shows significant link between failure to respond to standard therapy and presence of the multi-drug resistance mechanism P-glycoprotein, underlining the opportunity for AS1413, which bypasses multi-drug resistance
· Analysis of phase II data shows comparable activity with AS1413 plus cytarabine in the two subgroups of secondary AML patients being studied in the ongoing AS1413 phase III trial (patients with prior myelodysplastic syndrome (MDS) and patients previously treated for other cancers)
· Follow up of AS1411 phase II trial in relapsed/refractory AML shows durable remissions among patients who responded to AS1411 plus cytarabine, supporting ongoing development of AS1411 in AML
· Phase II trial of AS1411 in renal cancer provides further evidence of anti-cancer activity, suggesting that AS1411 could have application in a variety of cancer settings
P-glycoprotein (Pgp) is a cell-membrane pump that removes chemotherapy drugs from cells. It is a key contributor to multi-drug resistance (MDR) and is common in cancer cells of patients with AML. Today's Leukemia poster session includes a meta-analysis evaluating the impact of Pgp on remission rates in AML. Presented by Professor J.-P. Marie of the HÃ'pital Dieu, Paris, France, it includes 74 published studies with over 4,500 evaluable patients, all of whom were treated with currently available therapies for AML.
The meta-analysis shows that the presence of Pgp significantly reduces the likelihood of achieving complete remission with currently available therapies (overall remission rates were 74% in patients with Pgp-negative disease and 46% in patients with Pgp-positive disease). This highlights the need for new treatments unaffected by Pgp. Antisoma's AS1413 (amonafide L-malate) is known to evade Pgp and other MDR mechanisms. It is therefore being developed as a potential alternative to anthracyclines and related AML treatments that are susceptible to MDR. A 450-patient randomised phase III trial, ACCEDE, is comparing AS1413 with the anthracycline daunorubicin in patients with secondary AML, where MDR is particularly common and outcomes with current therapies are poor.
Prof Marie said: "This meta-analysis underlines the importance of multi-drug resistance as a factor compromising the results of current treatments for AML and highlights the need for new treatments that can bypass multi-drug resistance mechanisms."
The Leukemia poster session also includes a new evaluation of data from Antisoma's phase II trial of AS1413 in secondary AML. Performed by Dr Mikkael Sekeres, Director of the Leukemia Program at the Cleveland Clinic, and colleagues, this compares outcomes in the two groups of patients that together comprise secondary AML: those with prior MDS and those with a history of treatment with radiotherapy or chemotherapy for other cancers. Response rates and longer term outcomes in the two patient types were comparable, reinforcing the validity of secondary AML as a grouping when considering treatment options for these patients.
A third presentation in the Leukemia session reports updated findings from Antisoma's randomised phase II trial of AS1411 in relapsed and refractory AML. This trial previously reported a higher remission rate in patients receiving AS1411 plus high-dose cytarabine (~20%) compared with patients receiving cytarabine alone (~5%). The new data, presented by Dr Robert Stuart of the Medical University of South Carolina, show that a number of the patients who responded to the AS1411-based regimen appeared to derive longer term benefit, with substantial survival durations (12-20 months plus) in five of the eight responding patients.
Monday's Genitourinary Cancer poster session includes the findings from a 35-patient phase II study of AS1411 as monotherapy in advanced renal cancer refractory to at least one tyrosine kinase inhibitor. While Antisoma has decided not to pursue this indication for commercial reasons, the data provide further evidence that AS1411 has activity in a variety of cancer settings. The presentation, given by Dr Jonathan Rosenberg of the Dana-Farber/Harvard Cancer Center, shows that one patient had a sustained partial response, with tumour shrinkage exceeding 80%. Twenty-one patients (60%) showed disease stabilisation according to independent assessment, which indicated that median progression-free survival was 3.9 months, comparable with values reported for active agents in the same setting.
The new 'Trials in Progress' session on Monday includes poster presentations on both AS1413 and AS1411. One details an ongoing phase IIa pharmacokinetic and efficacy study of AS1413, which includes a broader range of AML patients than the current phase III study. The other describes the randomised phase IIb study of AS1411 in relapsed and refractory AML, which is expected to report headline data in the first half of 2011.
Details of the presentations at the meeting are provided below. The posters will be made available at www.antisoma.com ( http://www.antisoma.com/ ) when they have been presented.
Enquiries:
Antisoma plc:
Glyn Edwards, CEO
(In London) +44 (0)20 3249 2100
Daniel Elger, VP Marketing&Communications
(In Chicago) +44 (0)7909 915 068
Mark Court/Lisa Baderoon/Catherine Breen +44 (0)20 7466 5000
Buchanan Communications
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.
Details of the presentations at ASCO
General poster session: Leukemia, Myelodysplasia, and Transplantation;
Saturday, June 5, 8am-12pm, S Hall A2
* #6557; Board 14G: Long-term outcomes of responders in a randomized, controlled phase II trial of aptamer AS1411 in AML. Rizzieri et al.
* #6582; Board 17H: Treatment-related AML and AML evolving from MDS: Similar outcomes following treatment with amonafide plus cytarabine. Sekeres et al.
* #6586; Board 18D: Effect of the presence of P-glycoprotein (MDR1) on the ability of AML patients to achieve complete remission: Results of a meta-analysis of the literature. Marie et al.
Trials in Progress Poster Session (Special Session, Clinical Trials); Monday, June 7, 8am-12pm, S Hall A2
* #TPS278; Board 48A: A phase IIa pharmacokinetic and efficacy study of amonafide (AS1413) in combination with cytarabine in patients with acute myeloid leukemia. Lundberg et al.
* #TPS279; Board 48B: A multicenter dose-finding randomized controlled phase IIb study of the aptamer AS1411 in patients with primary refractory or relapsed AML. Stuart et al.
General poster session: Genitourinary Cancer; Monday, June 7, 1pm-5pm, S Hall A2
* #4590; Board 4A: A phase II, single-arm study of AS1411 in metastatic renal cell carcinoma (RCC). Rosenberg et al.
About AML (acute myeloid leukaemia)
AML is a type of cancer in which the bone marrow makes abnormal and immature blood cells, eventually leading to bone marrow failure. The American Cancer Society estimates that there will be over 13,000 new cases of AML diagnosed this year in the US alone.
About AS1413 (amonafide L-malate)
AS1413 (amonafide L-malate) was added to Antisoma's pipeline through the acquisition of Xanthus Pharmaceuticals, Inc. in June 2008. AS1413 is a novel DNA intercalator that induces apoptotic signalling by blocking topoisomerase II binding to DNA. This differs from the action of classical topoisomerase II inhibitors, which induce apoptosis by causing extensive DNA damage. A further distinctive feature of AS1413 is its ability to evade Pgp and related transporters responsible for multi-drug resistance (MDR). A pivotal phase III trial (ACCEDE) is evaluating AS1413 as a treatment for secondary AML, a condition often associated with MDR and in which outcomes with currently available treatments are poor. Earlier this month, the US Food and Drug Administration granted AS1413 Fast Track status for the treatment of secondary AML.
About AS1411
AS1411 was originally developed by Dr Paula Bates, Dr John Trent and Prof. Donald Miller at the University of Alabama and later at the University of Louisville. Antisoma added AS1411 to its pipeline when it acquired the Louisville-based company Aptamera Inc. in 2005. AS1411 belongs to a new type of drugs called aptamers. These are short pieces of DNA or RNA that fold into three-dimensional structures capable of targeting particular proteins. AS1411 is a DNA aptamer that binds to nucleolin, a protein expressed in the nucleus of all cells but which in cancer cells is also exposed on the cell surface, providing a basis for specific targeting by AS1411. When AS1411 binds to nucleolin on cancer cells, it is internalised and causes apoptosis through interference with various functions of nucleolin. AS1411 is being evaluated in a phase IIb trial in patients with relapsed and refractory AML.
About 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 ( http://www.antisoma.com/ ) for further information about Antisoma.
HUG#1421805
© 2010 Hugin-News
peewee
15 years ago
EDIT(it can only be that then ax ?): Jefferies to Host 2010 Global Life Sciences Conference
Please join us for our Inaugural Jefferies Global Life Sciences Conference on June 8-11, 2010 in New York City, which will feature presentations from over 300 leading public and private healthcare companies across the life sciences spectrum, including biotechnology, life science tools, medical devices, diagnostics, specialty pharmaceuticals, and multi-national pharma. The four day conference will feature five concurrent tracks of company presentations, lunch panel discussions, a keynote presentation and investor meetings. We hope you are able to join us for the largest dedicated collection of life sciences companies from around the world, providing investors with a comprehensive and competitive view of the industry.
For additional information, please contact your Jefferies sales representative.
http://www.jefferies.com/cositemgr.pl/html/OurFirm/ConferencesEvents/upcoming/20100608GlobalLifeSciences.shtml
-----------------------------------------------------
Annual Global Healthcare Services Conference
Jefferies will host its Inaugural Global Healthcare Services Conference on January 25-27, 2010 which will feature presentations from more than 130 leading public and private companies within the areas of acute care, alternate site, distribution, healthcare IT, laboratory services, long-term care, managed care, medical malpractice insurance, pharmacy benefits management, pharmaceutical services, REITs, staffing and related areas within healthcare services.
This three-day conference will be composed of concurrent tracks of company presentations, breakout sessions and lunch panels. Please join us for what promises to be a comprehensive gathering of institutional investors, private equity investors and leading healthcare executives to discuss investment themes, trends and developments within the industry.
For additional questions, please contact you Jefferies sales representative.
Click here to access the Webcast
http://www.wsw.com/webcast/jeff40/
http://www.jefferies.com/cositemgr.pl/html/OurFirm/ConferencesEvents/past/20100125GlobalHealthcare.shtml
califax
15 years ago
ASCO Trials in Progress Poster Session 06/07,2010
Session: Trials in Progress Poster Session
Type: Trials in Progress Poster Session
Time: Monday June 7, 8:00 AM to 12:00 PM
Location: S Hall A2
http://abstract.asco.org/AbstView_74_49960.html
A multicenter dose-finding randomized controlled phase IIb study of the aptamer AS1411 in patients with primary refractory or relapsed AML.
Sub-category: Leukemia
Category: Leukemia, Myelodysplasia, and Transplantation
Meeting: 2010 ASCO Annual Meeting
Citation: J Clin Oncol 28:7s, 2010 (suppl; abstr TPS279)
Abstract No: TPS279
Author(s): R. K. Stuart, A. Wei, I. D. Lewis, E. Estey, F. Erlandsson, G. J. Schiller; Medical University of South Carolina, Charleston, SC; The Alfred Hospital, Melbourne, Australia; Royal Adelaide Hospital, Adelaide, Australia; University of Washington Medical Center, Seattle, WA; Antisoma Research Ltd., London, United Kingdom; University of California, Los Angeles School of Medicine, Los Angeles, CA
Abstract:
Background: Aptamers are small synthetic oligonucleotides that form stable nuclease-resistant 3D structures and bind target proteins with specificity and affinity similar to antibodies. These "chemical antibodies" represent a new class of therapeutics. AS1411 is the first aptamer to enter phase II trials in cancer. The AS1411 aptamer binds nucleolin, which is overexpressed on the surface of cancer cells, and induces apoptosis. A 70-patient randomized controlled phase II trial evaluated AS1411 in combination with cytarabine in patients with relapsed and refractory AML. Patients were treated with AS1411 10 mg/kg/day + cytarabine 3 g/m2/day (AS1411-10), AS1411 40 mg/kg/day + cytarabine 3 g/m2/day (AS1411-40), or cytarabine 3 g/m2/day alone (control). CR+CRp rates were: AS1411-10, 21%; AS1411-40, 19%; control, 5%. The combination was well tolerated. These findings led to the current phase IIb study, which tests the value of a further doubling in the dose of AS1411 against a background of a slightly higher cytarabine dose in less heavily treated AML patients. Methods: 90 patients will be randomized 1:1:1 to 3 arms: AS1411 40 mg/kg/day + cytarabine 4 g/m2/day, AS1411 80 mg/kg/day + cytarabine 4 g/m2/day, or cytarabine 4 g/m2/day alone (control). AS1411 will be administered CI days 1-7, and cytarabine will be administered bid IV days 4-7. Patients aged 18-70 with ECOG 0-2 must have primary refractory AML with > 20% blasts on baseline bone marrow assessment or AML in first relapse with > 5% marrow blasts. Key exclusion criteria are APL, secondary AML, and clinically active CNS leukemia. The primary objective of the study is to compare response rates (CR+CRi) with the three regimens. Secondary objectives are comparisons of duration of remission, disease-free survival and overall survival, hematologic recovery and safety, and assessment of pharmacokinetics. Exploratory pharmacodynamic assessment of the effects of AS1411 will be carried out on bone marrow aspirate and trephine biopsy samples taken before and after treatment. Patients who do not respond to cytarabine alone will be eligible to cross over to receive AS1411 + cytarabine at the investigator's discretion.
califax
15 years ago
ASCO General Poster Session 06/05,2010
Session: Leukemia, Myelodysplasia, and Transplantation
Type: General Poster Session
Time: Saturday June 5, 8:00 AM to 12:00 PM
Location: S Hall A2
http://abstract.asco.org/AbstView_74_49933.html
Long-term outcomes of responders in a randomized, controlled phase II trial of aptamer AS1411 in AML.
Sub-category: Leukemia
Category: Leukemia, Myelodysplasia, and Transplantation
Meeting: 2010 ASCO Annual Meeting
Citation: J Clin Oncol 28:7s, 2010 (suppl; abstr 6557)
Abstract No: 6557
Author(s): D. Rizzieri, K. Stockerl-Goldstein, A. Wei, R. H. Herzig, F. Erlandsson, R. K. Stuart; Duke University Medical Center, Durham, NC; Washington University, St Louis, MO; The Alfred Hospital, Melbourne, Australia; Brown Cancer Center, Louisville, KY; Antisoma Research Ltd., London, United Kingdom; Medical University of South Carolina, Charleston, SC
Abstract:
Background: AS1411 is the most advanced aptamer in oncology clinical development. It targets nucleolin, a protein upregulated on the surface of cancer cells. Data from a phase II study of AS1411 in relapsed and refractory AML were reported at ASCO 2009. In this update, we report follow-up data for the responders in the study. Methods: This randomized, multicenter phase II trial compared AS1411 plus high-dose cytarabine (HiDAC) to HiDAC alone as treatment for relapsed (=3 previous lines of therapy) or refractory AML. Patients in cohort I were randomized 2:1 to receive AS1411 10 mg/kg/day IV CI days 1-7 + HiDAC 1.5 g/m2 bid days 4-7 (AS1411-10), or HiDAC alone for 4 days (control). Following safety assessment, a second cohort was randomized to receive AS1411 40 mg/kg/day + HiDAC (AS1411-40) or HiDAC alone. Objectives were comparison of response rates (CR+CRp), safety and tolerability between groups. For this analysis, we collected data on post-remission therapy (PRT) and overall survival (OS) among responders. Results: 71 patients were randomized: 22 to AS1411-10, 26 to AS1411-40 and 23 to control. 67 patients were evaluable for safety (AS1411-10, 21; AS1411 40, 25; control, 21). Grade 3 and 4 toxicities were similar across all groups: febrile neutropenia, neutropenia, thrombocytopenia, and infections. Deaths within 28 days of treatment were: AS1411-10, 1/21; AS1411-40, 2/25; and control, 3/21. 59 patients were evaluable for response; AS1411-10, 21% (4CR/19); AS1411-40, 19% (2CR+2CRp/21); and control, 5% (1CRp/19). PRT and OS data for responding patients are tabulated. Conclusions: This phase II trial suggested that addition of AS1411 to cytarabine may enhance anti-leukemic activity and that the combination has an acceptable safety profile in patients with relapsed and refractory AML. Follow-up suggests substantial survival durations in some patients responding to AS1411 + cytarabine. A phase IIb study is now evaluating responses, duration of responses and survival in AML patients randomized to AS1411 + cytarabine or cytarabine alone.
califax
15 years ago
ASCO General Poster Session 06/07,2010
Session: Genitourinary Cancer
Type: General Poster Session
Time: Monday June 7, 1:00 PM to 5:00 PM
Location: S Hall A2
http://abstract.asco.org/AbstView_74_49790.html
A phase II, single-arm study of AS1411 in metastatic renal cell carcinoma (RCC).
Sub-category: Kidney Cancer
Category: Genitourinary Cancer
Meeting: 2010 ASCO Annual Meeting
Citation: J Clin Oncol 28:7s, 2010 (suppl; abstr 4590)
Abstract No: 4590
Attend this session at the ASCO Annual Meeting!
Session: Genitourinary Cancer
Type: General Poster Session
Time: Monday June 7, 1:00 PM to 5:00 PM
Location: S Hall A2
A phase II, single-arm study of AS1411 in metastatic renal cell carcinoma (RCC).
Sub-category: Kidney Cancer
Category: Genitourinary Cancer
Meeting: 2010 ASCO Annual Meeting
Citation: J Clin Oncol 28:7s, 2010 (suppl; abstr 4590)
Abstract No: 4590
Author(s): J. E. Rosenberg, H. A. Drabkin, P. Lara Jr., A. L. Harzstark, R. A. Figlin, G. W. Smith, F. Erlandsson, D. A. Laber; Dana-Farber Cancer Institute/Harvard Medical School, Boston, MA; Medical University of South Carolina, Charleston, SC; University of California, Davis, Sacramento, CA; University of California, San Francisco, San Francisco, CA; City of Hope, Duarte, CA; St. Francis Hospital, Beech Grove, IN; Antisoma Research Ltd., London, United Kingdom; James Graham Brown Cancer Center, University of Louisville, Louisville, KY
Abstract:
Background: AS1411 is a DNA aptamer that targets nucleolin. Although normally present in the nucleolus, nucleolin is overexpressed and shows localization to the plasma membrane in renal and other cancer cells. A dose-escalating phase I trial of AS1411 monotherapy reported 1 complete response (CR) and 1 partial response (PR) among 12 patients with advanced RCC. A randomized phase II trial in AML reported increased CR rates when AS1411 was added to high-dose cytarabine. Methods: This phase II single-arm study evaluated AS1411 monotherapy in patients with metastatic, predominantly clear cell, RCC who had failed, or shown intolerance to, =1 prior treatment, including a tyrosine kinase inhibitor. AS1411 was administered at 40 mg/kg/day CI days 1-4 of a 28 day cycle for 2 cycles. Response evaluation using RECIST occurred every 8 weeks from the start of therapy until disease progression (performed by investigators and by an independent radiologist). The primary endpoint was response rate (CR+PR); progression-free survival (PFS), duration of response, and safety were secondary endpoints. Pharmacokinetic (PK) analysis was performed. Results: 35 patients were enrolled and treated; the median no. prior therapies was 2 (range 1-7). 33 completed 2 cycles of treatment. Independent response assessment indicated 1 PR (3%) and 21 cases of stable disease (SD; 60%); investigator assessment indicated 1 PR (3%) and 12 SD (34%). The patient achieving a PR exhibited a decreased sum of unidimensional target lesion measurements of = 80%, and remains in PR at 5.9 months. Independently assessed median PFS was 3.9 months. No = grade 4 adverse events were recorded; fatigue and constipation were the most common grade 1-3 adverse events occurring in 29% and 34% of patients, respectively. No other toxicity was observed in more than 10% of patients. PK analysis demonstrated a median steady-state plasma concentration of 21 µg/mL, which is similar to the IC50 concentration identified for renal cancer cell lines in vitro. Conclusions: AS1411 has activity in RCC with minimal toxicity; PFS was comparable to that seen with active agents in the refractory setting. Further studies are needed to determine the optimal dosing and scheduling for this novel therapeutic.
califax
15 years ago
ASCO Trials in Progress Poster Session 06/07,2010
Session: Trials in Progress Poster Session
Type: Trials in Progress Poster Session
Time: Monday June 7, 8:00 AM to 12:00 PM
Location: S Hall A2
http://www.asco.org/portal/site/ascov2/gsasearch?q=AS1413&x=31&y=5
A phase IIa pharmacokinetic and efficacy study of amonafide (AS1413) in combination with cytarabine in patients with acute myeloid leukemia.
Sub-category: Leukemia
Category: Leukemia, Myelodysplasia, and Transplantation
Meeting: 2010 ASCO Annual Meeting
Citation: J Clin Oncol 28:7s, 2010 (suppl; abstr TPS278)
Abstract No: TPS278
Attend this session at the ASCO Annual Meeting!
Session: Trials in Progress Poster Session
Type: Trials in Progress Poster Session
Time: Monday June 7, 8:00 AM to 12:00 PM
Location: S Hall A2
Personalize your Annual Meeting experience with a suggested or customized itinerary!
Author(s): A. S. Lundberg, S. L. Allen, AS1413-101 Investigator Group; Antisoma, Cambridge, MA; North Shore Long Island Jewish Health System, Manhasset, NY
Abstract:
Background: Amonafide is a novel DNA intercalator that is not affected by multidrug resistance mechanisms, a common cause of treatment failure in AML. Amonafide has previously been studied in combination with cytarabine in patients with secondary AML in a phase I dose- escalation study and a phase II safety and efficacy study. The phase III ACCEDE study is comparing amonafide + cytarabine to daunorubicin + cytarabine in previously untreated secondary AML (sAML). The pharmacokinetics (PK) of amonafide when given at lower doses and as monotherapy has been extensively studied. This study is designed to further determine the amonafide PK in the combination antileukemic regimen being evaluated clinically and to facilitate the development of a population PK model for further clinical studies. Methods: This is a multicenter, single-arm, fixed-dose phase IIa study of amonafide + cytarabine in with newly diagnosed, relapsed, or refractory adult patients with AML. The objectives of the study are to define the plasma PK profile and urinary excretion of amonafide and metabolite(s) and to evaluate the safety, tolerability, and remission rate of amonafide in combination with cytarabine. Patients will receive therapy with amonafide 600 mg/m2/day IV over 4 hours daily on days 1-5 in combination with cytarabine 200 mg/m2 IV CI daily on days 1-7, with a second course for persistent leukemia on day 14. Up to 30 patients are expected to be enrolled and treated in this study.
califax
15 years ago
Antisoma Interim Management Statement
http://www.antisoma.com/asm/media/press/pr2010/2010-05-17/
London, UK, and Cambridge, MA: 17 May 2010 – Cancer drug developer Antisoma plc (LSE: ASM; USOTC: ATSMY) today publishes its Interim Management Statement for the period from 1 January to 16 May 2010.
Antisoma’s CEO, Glyn Edwards, said: “We have two promising cancer drugs, AS1413 and AS1411, both of which we expect to report key trial data during the next year. Having taken measures to reduce our costs, we expect our cash resources to take us well past these trial results.”
Joint Chairman and CEO’s statement
We are determined to bounce back strongly from the recent disappointment over ASA404, centred on the termination in March of a phase III trial evaluating the drug as a first-line treatment for lung cancer. We recognise that ASA404 was considered the Company’s most significant asset, but we are confident that Antisoma’s strategy of investment in a diversified portfolio of products remains sound. We have had to make tough decisions in light of the ASA404 result, but believe that we have the product assets, people and financial resources to build value for the future.
AS1413 – rapid recruitment continues in phase III trial
AS1413 is a novel chemotherapy treatment that we are testing in a large, multi-country, randomised phase III trial in patients with secondary acute myeloid leukaemia (secondary AML). The trial, known as ACCEDE, has now recruited over 75% of its target of 450 patients, putting us on course to complete enrolment this calendar year. Following collection and processing of data, we expect to announce results of the study during the first half of 2011.
There is interest from potential licensing partners for AS1413. We have decided to take a pragmatic stance to realising the value of this drug, and have therefore widened our partnering discussions to include US rights, which we had previously planned to retain. However, we will only strike a deal ahead of the phase III data if the terms are sufficiently favourable.
We believe that AS1413 could ultimately find application in a number of blood cancer settings, with potential sales running to hundreds of millions of dollars annually. A presentation at the American Association of Cancer Research (AACR) Annual Meeting during April reinforced the differentiation of AS1413 from currently available leukaemia treatments and its potential to provide unique benefits for patients. Three presentations with relevance to AS1413 will be made at the American Society of Clinical Oncology (ASCO) Annual Meeting in June; abstracts will be available on the ASCO website (www.asco.org) from 20 May.
AS1411 – phase IIb trial now underway
AS1411 is the most advanced aptamer in trials for cancer. It is now in a 90-patient phase IIb study in patients with AML. This trial follows an earlier randomised phase II trial in AML, which reported positive results at the 2009 ASCO meeting: in that study, two different doses of AS1411 in combination with cytarabine chemotherapy produced response rates of around 20%, whereas the response rate in patients receiving chemotherapy alone was 5%. Addition of AS1411 to chemotherapy was not associated with any significant additional side-effects. Headline data from the phase IIb study are expected in the first half of next year.
Recent and forthcoming conference presentations highlight the broad potential of AS1411. Non-clinical data presented at AACR in April showed activity in a model of colorectal cancer and positive findings when AS1411 was combined with a number of approved treatments for blood cancers. At the ASCO meeting we will have three presentations on AS1411, including updated findings from the first phase II clinical trial in AML and data from a phase II clinical trial in renal cancer.
DCAM auto-immune programme progressing towards partnering
We have an important pre-clinical programme in auto-immune diseases. This comprises a series of molecules collectively known as DCAMs (dendritic cell auto-immune modulators). They are highly specific, small-molecule inhibitors of wild-type Flt3, and are designed for oral treatment of various auto-immune conditions. Positive results have already been achieved in animal models of inflammatory bowel disease and rheumatoid arthritis, and we are now working towards establishing a licensing partnership for further development of the programme.
Cash conservation measures enacted
We are no longer anticipating further revenues from the ASA404 programme, and have therefore taken steps to reduce our cash utilisation and ensure that our funds take us comfortably through key clinical data on AS1413 and AS1411. We announced on 29 March that our unaudited cash position as of the end of February 2010 was GBP 45.1 million.
Board and management changes
Regrettably, we have had to restructure the business and make headcount reductions as part of our effort to conserve cash resources. As part of the restructuring, our former Chief Operating Officer, Dr Ursula Ney, has left the Company and the Antisoma Board. Ursula made a very significant contribution to the development of Antisoma, and we wish her well with future ventures. Two other members of the Senior Management Team, Julio Gagne and Kevin Kissane, have also left the Company, and our total headcount has now been reduced to around seventy-five.
Outlook
We look forward to a number of important clinical milestones in the near term, notably phase III data on AS1413 and phase IIb data on AS1411, both of which we expect during the next year.
Enquiries:
Glyn Edwards, CEO
Daniel Elger, VP, Marketing & Communications +44 (0) 7909 915068
Antisoma plc
Mark Court/Lisa Baderoon/Catherine Breen +44 (0)20 7466 5000
Buchanan Communications
Seth Lewis +1 617 583 1308
The Trout Group
This Interim Management Statement is published in accordance with the UK Listing Authority’s Disclosure Rules and Transparency Rules, in respect of the period from 1 January 2010 to 16 May 2010.
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 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.
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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