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Notification of Preliminary Results
Date : 07/20/2010 @ 5:00AM
Source : UK Regulatory (RNS & others)
Stock : Antisoma (ASM)
http://ih.advfn.com/p.php?pid=nmona&article=43662614&symbol=L^ASM
London, UK, and Cambridge, MA: 20 July 2010 - Antisoma plc (LSE: ASM; USOTC: ATSMY) will be announcing its Preliminary Results for the year ended 30 June 2010 on Thursday 29 July 2010.
Enquiries:
Daniel Elger
VP, Marketing & Communications
Antisoma plc
+44 7909 915 068
Mark Court/Lisa Baderoon/Catherine Breen
Buchanan Communications
+44 (0)20 7466 5000
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 visitwww.antisoma.com for further information about Antisoma.
[HUG#1432737]
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
IR contacts
For investor relations enquiries please contact:
Alison Saville
Tel: +44 (0) 20 3249 2100
Fax: +44 (0) 20 3249 2101
enquiries@antisoma.com
Registered Office: Chiswick Park Building 5, 566 Chiswick High Road, London W4 5YF, UK
Registered in England and Wales No. 3248123
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.
4th Annual Jefferies Healthcare Conference (06/11/10)
Antisoma to present at 9th Annual Needham Life Sciences Conference and 4th Annual Jefferies Healthcare Conference in New York
Date : 06/04/2010 @ 7:00AM
http://ih.advfn.com/p.php?pid=nmona&article=43096649&symbol=L^ASM
04 June 2010, London, UK, and Cambridge, MA: Antisoma plc (LSE: ASM; USOTC:ATSMY) announces that Daniel Elger, VP Marketing & Communications, will present at the 4th Annual Jefferies Healthcare Conference in New York at 12.45 pm local time (5.45 pm BST) on Friday 11 June.
Enquiries:
Alison Saville
Senior Marketing and Communications Executive
Antisoma plc
+44 (0)20 3249 2100
9th Annual Needham Life Sciences Conference (06/10/10)
Antisoma to present at 9th Annual Needham Life Sciences Conference and 4th Annual Jefferies Healthcare Conference in New York
Date : 06/04/2010 @ 7:00AM
http://ih.advfn.com/p.php?pid=nmona&article=43096649&symbol=L^ASM
04 June 2010, London, UK, and Cambridge, MA: Antisoma plc (LSE: ASM; USOTC:ATSMY) announces that Daniel Elger, VP Marketing & Communications, will present at the 9th Annual Needham Life Sciences Conference in New York at 09.20 am local time (2.20 pm BST) on Thursday 10 June
A webcast of the presentation at the Needham conference will be available on Antisoma's website at http://www.antisoma.com/asm/media/webcast/
For live viewing of the webcast, it is recommended that viewers log on 15 minutes early in order to register and download any necessary software.
Enquiries:
Alison Saville
Senior Marketing and Communications Executive
Antisoma plc
+44 (0)20 3249 2100
Static CHART, imo its just starting...
http://investorshub.advfn.com/uimage/uploads/2010/6/7/gyhofantisomazkb.jpg
Presentations from the Leukemia session at ASCO (part1)
06/05/10 - AS1413 presentations at ASCO 2010
Pgp impacts on CR rates in AML, poster presentation at ASCO, Chicago 2010
http://www.antisoma.com/asm/products/as1413/asco_chicago2010.pdf
06/05/10 - AS1411 presentations at ASCO 2010
Long-term outcomes of patients responding to AS1411 regimen, poster presentation at ASCO, Chicago 2010
http://www.antisoma.com/asm/products/as1411/as1411_2010.pdf
http://www.antisoma.com/asm/
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
Ax man ; Cool ..very helpfull indeed. Thnx..
Should be carefull with your picks tho.. like CXM. Deep shoot in there! Are you still holding in CXM? heheheh ? are you in this puppy? to what extend?
ASCO - Saturday June 5,
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
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
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.
Someone must email to the IR and tell them to correct the PR !
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
9th Annual Needham Healthcare Conference
June 09 - June 10, 2010
Needham & Company’s 9th Annual Healthcare Conference is a high-impact forum for institutional investors and venture capital firms to hear the latest updates from senior management teams of both public and private companies in the Biotechnology, Specialty Pharmaceuticals, Medical Technology and Diagnostics sectors. Over the course of two days, attendees can participate in moderated company presentations, as well as expert panels of clinical and industry professionals. One-on-one meetings with companies will be available for qualified institutional investors and venture capital firms. Please contact your Needham salesperson for registration details as space will be limited.
http://www.needhamco.com/Default/InstitutionalSalesAndTrading/Conferences.aspx
Antisoma to present at 9th Annual Needham Life Sciences Conference and 4th Annual Jefferies Healthcare Conference in New York
Date : 06/04/2010 @ 7:00AM
http://ih.advfn.com/p.php?pid=nmona&article=43096649&symbol=L^ASM
04 June 2010, London, UK, and Cambridge, MA: Antisoma plc (LSE: ASM; USOTC:
ATSMY) announces that Daniel Elger, VP Marketing & Communications, will present at the 9th Annual Needham Life Sciences Conference in New York at 09.20 am local time (2.20 pm BST) on Thursday 10 June and the 4th Annual Jefferies Healthcare Conference in New York at 12.45 pm local time (5.45 pm BST) on Friday 11 June.
A webcast of the presentation at the Needham conference will be available on
Antisoma's website athttp://www.antisoma.com/asm/media/webcast/
For live viewing of the webcast, it is recommended that viewers log on 15
minutes early in order to register and download any necessary software.
Enquiries:
Alison Saville
Senior Marketing and Communications Executive
Antisoma plc
+44 (0)20 3249 2100
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 visitwww.antisoma.com <http://www.antisoma.com> for
further information about Antisoma.
ASCO 2010 - Poster Sessions by Antisoma
AS1411
Saturday June 5, 8:00 AM to 12:00 PM
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.
Monday June 7, 8:00 AM to 12:00 PM
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.
Monday June 7, 1:00 PM to 5:00 PM
http://abstract.asco.org/AbstView_74_49790.html
A phase II, single-arm study of AS1411 in metastatic renal cell carcinoma (RCC).
AS1413
Monday June 7, 8:00 AM to 12:00 PM
http://abstract.asco.org/AbstView_74_49982.html
A phase IIa pharmacokinetic and efficacy study of amonafide (AS1413) in combination with cytarabine in patients with acute myeloid leukemia.
FDAnews Drug Daily Bulletin
June 4, 2010 | Vol. 7 No. 109
Antisoma’s AS1413 Gains FDA Fast Track Status for Myeloid Leukemia
Cancer drug developer Antisoma Thursday announced that the FDA has granted Fast Track designation to the Company’s novel DNA intercalator, AS1413 (amonafide L-malate), for the treatment of secondary acute myeloid leukemia.
http://www.fdanews.com/newsletter/article?issueId=13751&articleId=127580
04 Jun 2010 - Antisoma plc announced hat the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the Company's novel DNA intercalator, AS1413 (amonafide L-malate), for the treatment of secondary acute myeloid leukaemia (secondary AML).
The FDA's Fast Track programme is designed to facilitate the development of new drugs that have shown the potential to address an unmet medical need in a serious or life-threatening disease. Fast Track designated drugs ordinarily 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.
Glyn Edwards, CEO of Antisoma, said "We're very pleased to have gained FDA Fast Track status for AS1413. This drug could represent a major advance in the options available to patients with secondary AML, and we look forward to completing the ongoing phase III trial and sharing the data with FDA and other regulators."
AS1413 already has orphan drug status in both the U.S. and the E.U. for the treatment of AML.
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.
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.
Bid 7.05 Ask 7.10
Volume 4,157,912
Bid stacking up...woot woot !!!
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.
http://www.proactiveinvestors.com/companies/news/6296/antisomas-novel-leukaemia-treatment-fast-tracked-by-fda--6296.html
Thursday, June 03, 2010
Antisoma’s novel leukaemia treatment fast-tracked by FDA
Cancer focused biotechnology company, Antisoma (LON:ASM, OTC: ATSMY) told investors that its novel leukaemia treatment – the AS1413 DNA intercalator – has been granted a Fast Track designation by the US Food and Drug Administration (FDA).
The news has been welcomed by investors as the company’s shares advanced over 6.5% on the London Stock Exchange this morning.
FDA Fast Track designated drugs ordinarily 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. The novel DNA intercalator, AS1413 (amonafide L-malate), is being developed for the treatment of secondary acute myeloid leukaemia (secondary AML).
“This drug could represent a major advance in the options available to patients with secondary AML, and we look forward to completing the ongoing phase III trial and sharing the data with FDA and other regulators", Antisoma Chief Executive Glyn Edwards commented. "We're very pleased to have gained FDA Fast Track status for AS1413”.
The FDA's Fast Track programme is designed to facilitate the development of new drugs that have shown the potential to address an unmet medical need in a serious or life-threatening disease. The drug already has orphan drug status in both the US and the EU for the treatment of AML.
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.
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.
Hey ax..we have the ASCO now with how many presentations...??
I counted 6...lets see where we are next week !
IBOX updated (today)
PPS in GBp
London (GBp)
i.e Frankfurt (€)
USOTC ($) **
** Antisoma has a Level One American Depositary Receipt (ADR) Program.
http://www.antisoma.com/asm/ir/shareinfo/adr/
This will enable US investors in Antisoma to trade in a dollar-denominated security and is intended as a step towards a full listing of Antisoma's shares on NASDAQ.
Trading symbol: ATSMY
CUSIP number: 03718Q109
Ratio: 1 ADR : 20 Ordinary Antisoma shares
Antisoma has appointed The Bank of New York as the depositary bank for our ADR Program.
For more information please contact the Bank of New York:
Telephone from UK: 001 212 815 3700
Telephone from US: 1 888 269 2377 (1 888 BNY ADRS)
Email: shareowners@bankofny.com
www.bankofny.com
is PPS in pence or dollars? Where is this puppy trading and listed?
tia
Hehehe...just have seen that Error in the Quote...LOL !
Antisoma (LSE:ASM)
Last Price 6.10 GBp
Change 1.05 (20.79%)
Bid 6.15
Ask 6.23
Volume 6,383,459
Days Range 5.26 - 6.23
Last Trade 6/3/2010 11:35:12 AM
Antisoma (LSE:ASM)
Last Price (USD) $6.10
Change 1.05 (20.79%)
Bid 6.15
Ask 6.23
Volume 6,383,459
Days Range 5.26 - 6.23
Last Trade 6/3/2010 11:35:12 AM
Partnering conferences
A member of Antisoma's business development team will be present at the following conference(s):
ASCO, Chicago 4-8 June 2010
Euro-Biotech Forum, Paris 28-30 June 2010
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.
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.
http://events.jspargo.com/asco10/public/ExhibitorSearch.aspx?CatID=&SubCatID=&CountryID=&HallID=&PavID=&SubExpoID=&Keyword=&StateCodeID=&ExhibitorSearchIndex=A&SortBy=undefined&SubExpoCatIDs=
AACR presentations highlight potential of Antisoma drugs AS1413_and_AS1411
http://www.antisoma.com/asm/media/press/pr2010/2010-04-19/
London, UK, Cambridge, MA, and Washington, DC: 19 April 2010 – Antisoma plc (LSE:ASM; USOTC:ATSMY) announces that its scientists and collaborators are presenting six posters on AS1413 (amonafide L-malate) and AS1411 this week at the annual meeting of the American Association for Cancer Research in Washington, DC. The presentations highlight the distinctive features and potential of these two novel cancer drugs, both of which are in advanced clinical testing.
Glyn Edwards, CEO of Antisoma, said: “AS1413 and AS1411 are both un-partnered products with significant commercial potential. The latest data on AS1413 reinforce the clear differentiation of this drug from current leukaemia treatments and its potential to offer unique benefits to patients.”
AS1413 interferes with the replication of DNA prior to cancer cell division. The drug does this by preventing the enzyme Topoisomerase II (TopoII) from binding to DNA. One presentation shows how this action differs from that of classical TopoII inhibitors, a widely used class of cancer therapeutics. It demonstrates that AS1413 retains activity in leukaemia cells resistant to classical TopoII inhibitors. Antisoma is conducting a phase III trial of AS1413 in patients with secondary acute myeloid leukaemia (secondary AML), a disease where drug resistance is common. The trial compares AS1413-based treatment with standard current treatment based on the classical TopoII inhibitor daunorubicin.
A presentation on AS1411 demonstrates anti-tumour effects in a rat xenograft model of colorectal cancer. This adds to previous data from lung and renal cancer xenografts and data from cell lines representing many types of cancer. The findings are consistent with broad potential of AS1411 across solid and blood cancers.
Effects of AS1411 in an AML cell line are described in a further presentation. AS1411 killed leukaemia cells, and a combination of AS1411 with cytarabine produced synergistic (more than additive) anti-cancer effects. This drug combination is being evaluated in an ongoing phase IIb trial in patients with AML. Other experiments demonstrated synergistic effects of combinations between AS1411 and two of the newer approved products for treatment of blood cancers, decitabine and clofarabine.
Three posters from collaborators provide new data on the mechanisms by which AS1411 exerts its anti-cancer effects. Further details of all the presentations are provided below and on the AACR website at www.aacr.org.
Enquiries:
Glyn Edwards, CEO
+ 44 (0) 7909 915 068
Daniel Elger, VP, Marketing & Communications
Antisoma plc
Mark Court/Lisa Baderoon/Catherine Breen +44 (0)20 7466 5000
Buchanan Communications
Seth Lewis +1 646 378 2923
The Trout Group
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.
Details of the AACR presentations
AS1413
* #3665 The novel DNA intercalator amonafide (AS1413) disrupts the cell cycle by mechanisms distinct from topo II inhibitors daunorubicin and etoposide (Senderovich et al.) Tuesday, 20 Apr 2010, 9am-12pm; Exhibit Hall A-C, Poster Section 27
AS1411
* #3647 Gene expression analysis in AML cell line MV4-11 following treatment with the anti-cancer aptamer AS1411 (Senderovich et al.) Tuesday 20 Apr 2010, 9am-12pm; Exhibit Hall A-C, Poster Section 27
* #2614 Anti-tumor efficacy and pharmacokinetics of the novel aptamer AS1411 in a continuous infusion nude rat xenograft model (Green et al.) Monday 19 Apr 2010, 2-5pm; Exhibit Hall A-C, Poster Section 25
* #4450 A new paradigm for AS1411 activity: Uptake by macropinocytosis and induction of macropinocytosis by a nucleolin-dependent mechanism (Reyes-Reyes et al.) Tuesday 20 Apr 2010, 2-5pm; Exhibit Hall A-C, Poster Section 23
* #4455 Differential response to AS1411 in a pair of VHL-positive and VHL-negative renal carcinoma cell lines (Islam et al.) Tuesday 20 Apr 2010, 2-5pm; Exhibit Hall A-C, Poster Section 23
* #3642: AS1411 causes a specific increase in levels of cell surface nucleolin in responsive cell lines (Teng et al.) Tuesday 20 Apr 2010, 9am-12pm; Exhibit Hall A-C, Poster Section 27
A number of abstracts relating to ASA404 are also being presented at the meeting. Abstracts for all the presentations and details of their timings/location are available at www.aacr.org
About AS1413
AS1413 (amonafide L-malate) is a 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). Patients with secondary AML often have multi-drug resistant disease. In an 88-patient phase II trial, the combination of AS1413 and cytarabine produced a 38.6% CR rate in patients with secondary AML. The same regimen is being compared with daunorubicin plus cytarabine in a pivotal randomised phase III trial, ACCEDE, which is expected to report data in late 2010 or early 2011.
About AS1411
AS1411 is a DNA aptamer. Aptamers are short pieces of DNA or RNA that assume a specific three-dimensional shape capable of highly specific targeting. AS1411 binds to nucleolin, a protein expressed in the nucleus of all cells but which in cancer cells is also found on the cell surface. When AS1411 binds to nucleolin on cancer cells, it is internalised and causes apoptosis through interference with various functions of nucleolin. AS1411 was originally developed by Dr Paula Bates, Dr John Trent and Prof. Donald Miller at the University of Alabama and then at the University of Louisville. Antisoma added AS1411 to its pipeline when it acquired the Louisville-based company Aptamera Inc. in February 2005. Data from a randomised phase II trial combining AS1411 with cytarabine in patients with AML have provided evidence of activity, and a phase IIb trial is now ongoing in the same setting.
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 for further information about Antisoma.
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Antisoma is a biotechnology company specialising in the development of novel drugs for the treatment of cancer.
Antisoma has a diverse portfolio of drugs in development / pipeline
The Company was founded in 1988 and its shares are traded on the London Stock Exchange. Antisoma is based at offices in London and Cambridge, MA.
Antisoma Research Limited
Building 5
Chiswick Park
566 Chiswick High Road
London
W4 5YF
Alison Saville
Tel: +44 (0) 20 3249 2100
Fax: +44 (0) 20 3249 2101
enquiries@antisoma.com
AS1413 is a DNA intercalator that induces apoptotic signalling by blocking TopoII binding to DNA. Unlike classical TopoII inhibitors, a distinctive feature of AS1413 is its ability to evade PgP and related transporters responsible for multi-drug resistance. AS1413 is currently in phase III development in secondary AML.
AML is divided into two major categories, de-novo and secondary. AML is classified as secondary AML if it occurs as a result of a prior haematological disease or treatment with chemotherapy or radiation therapy or a combination of the two causes. In a phase II trial, treatment with AS1413 plus cytarabine resulted in a complete response rate of 38.6%, with an additional 3.4% showing CRi (complete response without recovery of blood cell count). This compares with CR rates of around 25% seen with standard treatment in similar AML patients enrolled in two large American studies. AS1413 is now in a phase III registration trial called ACCEDE. The ACCEDE trial compares AS1413 plus cytarabine with daunorubicin plus cytarabine in 450 patients
Latest presentation
AS1413 is distinct from daunorubicin and etoposide, poster presentation at AACR, Washington 2010
Pgp impacts on CR rates in AML, poster presentation at ASCO, Chicago 2010
AS1411 has shown activity against a wide range of solid and blood cancer cell lines in preclinical experiments and could therefore have potential against a variety of human cancers. Clinical development is focused on acute myeloid leukaemia (AML).
AS1411 is an aptamer. This is a type of drug based on a short piece of DNA or RNA. However, unlike some other drugs based on these chemicals, aptamers work as conventional drugs, binding to a protein target by virtue of a fit with its three-dimensional structure. The term aptamer is derived from the Greek ‘aptos’ (to fit).
AS1411 has a structure that allows it to bind specifically to a protein called nucleolin, which is found on the surface of many cancer cells. Once bound, the AS1411 aptamer is taken into the cancer cell, where it causes death by apoptosis (programmed cell death).
A previous phase I trial of AS1411 in 30 patients with various advanced cancers reported no serious adverse events related to treatment and promising signs of anti-cancer activity were seen.
Latest presentations
AS1411 novel combinations and microarray, poster presentation at AACR, Washington 2010
Long-term outcomes of patients responding to AS1411 regimen, poster presentation at ASCO, Chicago 2010
29 March 2010, London, UK, and Cambridge, MA: www.antisoma.com/asm/media/press/pr2010/2010-03-29/
Antisoma plc (LSE: ASM; USOTC: ATSMY) announces that the planned interim analysis of data from the ATTRACT-1 phase III trial of ASA404 in previously untreated non-small cell lung cancer (NSCLC) has shown that continuation of the trial would be futile, as there is little or no prospect of demonstrating a survival benefit with ASA404 in this setting. The ATTRACT-1 trial will therefore be halted.
06/03/2010 Antisoma's AS1413 gains FDA Fast Track status for treatment of secondary acute myeloid leukaemia
06/05/2010 Antisoma announces presentation at ASCO of new data supporting AS1413 and AS1411
06/14/2010 Antisoma announces AS1413 and AS1411 presentations at EHA
www.antisoma.com/asm/ir/reports/rep2009/ar2009/ar2009.pdf
Antisoma is looking for worldwide partners for the following products:
AS1413 A novel DNA intercalator in phase III for secondary AML
AS1411 A novel DNA aptamer in phase IIb for relapsed/refractory AML
AS1402 A humanised monoclonal antibody (huHMFG1) which targets the glycoprotein, MUC1, that is overexpressed and aberrantly glycosylated in the majority of epithelial tumors. Phase II data are available
AS1409 A fusion protein combining the anti-tumour cytokine IL-12, with the tumour-targeting antibody BC1. A phase I trial with AS1409 in patients with malignant melanoma and renal cell carcinoma has been completed
PPM1D Inhibitor Programme PPM1D is aberrantly amplified in a range of cancers. Activation results in negative regulation of p53 function and other tumour suppressor pathways. Additional functions include the regulation of the base excision pathways of DNA repair. Programme is at lead optimisation
Dendritic Cell Autoimmune Modulators (DCAM) A novel class of oral agents that target specific populations of dendritic cells to modulate the immune response
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06/02, 2010: 5,05 GBp
06/03, 2010: 6,10 GBp ( +20,79%) Board Created @ 5,85 GBp
Do your own DD & trade smart
www.antisoma.com/asm/ir/shareinfo/adr/
Antisoma has a Level One American Depositary Receipt (ADR) Program.
This will enable US investors in Antisoma to trade in a dollar-denominated security and is intended as a step towards a full listing of Antisoma's shares on NASDAQ.
Trading symbol: ATSMY
CUSIP number: 03718Q109
Ratio: 1 ADR : 20 Ordinary Antisoma shares
Antisoma has appointed The Bank of New York as the depositary bank for our ADR Program.
For more information please contact the Bank of New York:
Telephone from UK: 001 212 815 3700
Telephone from US: 1 888 269 2377 (1 888 BNY ADRS)
Email: shareowners@bankofny.com
www.bankofny.com
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