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KERX @ ASCO (Sunday, June 6, 2010)
http://ih.advfn.com/p.php?pid=nmona&article=42926420&symbol=N^KERX
Pediatric Oncology
Abstract Title: Phase I study of single-agent perifosine for recurrent pediatric solid tumors.
Presentation Date/Time: Sunday, June 6, 2010; 2:00 PM - 6:00 PM with poster discussion from 5:40 PM – 6:00 PM
Author: Oren J Becher, MD, Memorial Sloan-Kettering Cancer Center
Discussion Presenter: Mark Kieran, MD, PhD, Dana-Farber Cancer Institute
Permanent Abstract ID: 9540
Location: S Hall A2, Poster Board #42b, with discussion in S504
####################################################################################################
Abstract:
Background:
Perifosine is a synthetic alkylphospholipid which inhibits Akt activity and also has been reported to affect the JNK and MAPK signaling pathways. Single agent trials of perifosine in adults have demonstrated responses in patients with renal cell carcinoma, advanced brain tumors, soft-tissue sarcomas, hepatocellular carcinoma, as well as in hematologic malignancies including multiple myeloma and Waldenstrom's macroglobulinemia. We sought to determine the safety of perifosine in children with recurrent solid tumors
Methods:
Pediatric patients with recurrent solid tumors were enrolled in a phase I, open-label, dose-escalating study to assess pharmacokinetics (PK), and to identify the maximally tolerated dose (MTD). Cohorts of 3 pts were treated at three dose levels: 25mg/m2/day, 50mg/m2/day and 75mg/m2/day using 50mg tablets of perifosine after a loading dose on D#1
Results:
9 pts (4 male, 5 female) with high-grade glioma (n=5), medulloblastoma (n=2) or neuroblastoma (n=2) have been treated to date. Their median age was 13 years (range 5-18), most were heavily pretreated, with a median of 3 prior treatment regimens (range 1-10). No DLTs were observed. No = grade 3 toxicities or adverse events have been encountered. Grade 2 toxicities that were possibly related to perifosine include asthenia (22%), asymptomatic transaminase elevation (22%), neutropenia (33%), leukopenia (11%), hyperglycemia (22%), hypomagnesemia (22%), hypophosphatemia (11%), and colitis which resolved despite drug continuation (11%). Preliminary PK data resulted in the following steady state serum levels: 14.1±4µM for dose level 1, 32.8±8.1 µM for dose level 2, and 31.6 ±7.8µM for dose level 3.
Conclusions:
Perifosine is well tolerated in children with advanced solid tumors.
http://abstract.asco.org/AbstView_74_50552.html
ASCO Live Blog: Sunday
By Adam Feuerstein
http://www.thestreet.com/story/10773744/1/asco-live-blog-sunday.html
Biotech Calendar: Key Dates for June
By Adam Feuerstein 06/01/10 - 06:00 AM EDT
http://www.thestreet.com/story/10769834/1/biotech-calendar-key-dates-for-june.html
May 29-June 3
The American Urological Association annual meeting.
June 2
FDA advisory panel meets to review AstraZeneca's(AZN) Numax for respiratory syncytial virus.
June 3
BioDelivery Sciences(BDSI) analyst/investor meeting.
Johnson & Johnson(JNJ) analyst/investors meeting.
June 4-8
The American Society of Clinical Oncology (ASCO) annual meeting. Data presentation expected from Celldex Therapeutics(CLDX), Ziopharm(ZIOP), Delcath Systems(DCTH), Pfizer(PFE), Celgene(CELG) -- and too many other companies to mention here.
June 4
Cell Therapeutics(CTIC) annual shareholder meeting.
June 10
FDA advisory panel meets to review Novartis'(NVS) oral multiple sclerosis drug Gilenia. FDA's briefing materials should be posted to the agency's web site on June 8. The Gilenia panel is also important for Biogen Idec(BIIB), Teva(TEVA) and Merck-Serono, which market current injectable MS drugs.
June 10-13
European Hematological Association meeting.
June 11
FDA approval decision date for Questcor Pharmaceuticals'(QCOR) Acthar Gel for infantile spasms.
June 16
Genzyme(GENZ) annual shareholder meeting.
June 16-19
European League Against Rheumatism meeting. Lupus data presentations from Human Genome Sciences(HGSI) and UCB/Immunomedics(IMMU).
International Society for Stem Cell Research meeting.
June 18
FDA advisory panel meets to review Boehringer Ingelheim's filbanserin for the treatment of female sexual dysfunction. The filbanserin panel could also impact Biosante Pharmaceuticals(BPAX) and its competing female libido drug LibiGel, currently in phase III studies.
June 24
FDA approval decision date for AstraZeneca's Numax for respiratory syncytial virus.
Ligand Pharmaceuticals(LGND) analyst/investor day.
June 25-29
American Diabetes Association annual meeting.
Sometime in June
Phase III study results from Affymax's(AFFY) anemia drug Hematide.
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/
5 Banks That Might Get Burned by Reform
By Philip van Doorn
06/04/10 - 07:00 AM EDT
http://www.thestreet.com/story/10772996/1/5-banks-that-might-get-burned-by-reform.html
Celldex Therapeutics Presents Positive Results from Phase 1/2
05.06.2010 21:00
http://www.finanznachrichten.de/nachrichten-2010-06/17080366-celldex-therapeutics-presents-positive-results-from-phase-1-2-advanced-breast-cancer-study-with-cdx-011-at-46th-annual-asco-meeting-004.htm
Celldex Therapeutics Presents Positive Results from Phase 1/2 Advanced Breast Cancer Study with CDX-011 at 46th Annual ASCO Meeting
Study Achieves Primary Endpoint
Celldex Therapeutics, Inc. (NASDAQ: CLDX) today announced that mature results from a Phase 1/2 study evaluating CDX-011 in advanced stage breast cancer patients were presented at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO). CDX-011 is an experimental antibody-drug conjugate (ADC) directed against glycoprotein NMB (GPNMB) and linked to a potent cancer cell-killing drug, monomethyl-auristatin E (MMAE).
Mature data from this study of CDX-011 show a progression free survival (PFS) rate at 12 weeks of 35% of patients, which is a positive outcome for a heavily treated advanced breast cancer population with very limited treatment options. "The results in triple negative disease are especially encouraging," said Anthony Marucci, President and Chief Executive Officer of Celldex Therapeutics. "A subset analysis using a newly optimized diagnostic assay for GPNMB showed that patients with strong stromal or tumor cell expression of GPNMB may be most likely to respond to CDX-011."
"A reliable and marketable assay to detect a target antigen is critical in the development of any targeted therapy," said Tom Davis, M.D., Chief Medical Officer of Celldex Therapeutics. "We are confident that we can use our GPNMB assay to identify target expression patterns and levels in breast cancer to allow appropriate patient selection in our next study. A Phase 2b trial in advanced, refractory breast cancer is planned, which will select patients on the basis of significant GPNMB expression."
The trial, planned for initiation in Q3-2010, is a Phase 2, randomized, multi-center, controlled trial that will enroll 120 patients with heavily pre-treated, advanced breast cancer who are refractory/resistant to all approved therapies and whose tumors are confirmed to express significant levels of GPNMB via a validated, centralized diagnostic assay. It is anticipated that a significant portion of the enrolled patients will be triple-negative, since GPNMB is frequently expressed in this population. Patients will be randomized (2:1) to receive either CDX-011 or single-agent "Investigator's Choice" chemotherapy. Activity endpoints will include response rate and PFS. The study will be conducted in approximately 25 academic and community sites across the U.S.
Phase 1/2 Breast Cancer Study Overall Results
In the poster entitled Correlation of GPNMB Expression with Outcome in Breast Cancer (BC) Patients Treated with the Antibody-Drug Conjugate (ADC), CDX-011 (CR011-vcMMAE), Celldex described positive results from the Phase 1/2 trial. In this multicenter, open label, Phase 1/2 study, 42 patients with heavily pre-treated (median of seven prior anticancer regimens), progressive, locally advanced or metastatic breast cancer were administered CDX-011 as a 90 minute IV infusion, once every three weeks until intolerance or progression. In the Phase 1 portion of the study, sequential cohorts of patients were treated with escalating doses of CDX-011 to the pre-defined maximum of 1.88 mg/kg once every three weeks. The Phase 2 portion of the study enrolled an expanded cohort of patients at that maximum dose. Enrolled patients were not selected for GPNMB expression. The primary endpoint for the study, PFS rate at 12 weeks for the Phase 2 study portion, has been met, with a 12-week PFS rate of 35% (9 of 26). For all patients treated at the maximum dose level, tumor shrinkage was seen in 62% (16/26) and PFS was 9.1 weeks. A subset of 10 patients had "triple negative disease," a more aggressive breast cancer subtype that carries a high risk of relapse and reduced survival as well as limited therapeutic options due to lack of over-expression of HER2/neu, estrogen and progesterone receptors. In these patients, 78% (7/9) had any tumor shrinkage, 12-week PFS rate was 70% (7/10), and median PFS was 17.9 weeks. Tumor samples from a subset of patients across all dose groups were analyzed for GPNMB expression using a newly developed, validated, centralized assay intended for use in Phase 2 studies of CDX-011 and outcomes were examined for patients with significant stromal and tumor cell expression of GPNMB. In the small subset of patients with significant stromal or tumor cell expression of GPNMB, overall response rate was 22%, median PFS was 17.3 weeks, and the 12-week PFS rate was 67%. The most common treatment-related toxicities were fatigue, rash, nausea, alopecia (hair loss), neutropenia and vomiting.
About CDX-011
CDX-011 is an antibody-drug conjugate (ADC) that consists of a fully-human monoclonal antibody, CR011, linked to a potent cell-killing drug, monomethyl-auristatin E (MMAE). The ADC technology, comprised of MMAE and a stable linker system for attaching it to CR011, was licensed from Seattle Genetics, Inc. Following intravenous administration, CDX-011 targets and binds to GPNMB, a specific protein that is expressed in more than 40% of breast cancers as well as other tumor types, and which promotes the migration, invasion, and metastasis of breast cancer. Upon internalization into the targeted cell, CDX-011 is designed to release MMAE from CR011 to produce a cell-killing effect. CDX-011 has been shown to be safe and active, with observed objective responses, in two positive trials including the current breast cancer trial and a Phase 1/2 trial in advanced melanoma.
About Celldex Therapeutics, Inc.
Celldex Therapeutics is the first antibody-based combination immunotherapy company. Celldex has a pipeline of drug candidates in development for the treatment of cancer and other difficult-to-treat diseases based on its antibody focused Precision Targeted Immunotherapy Platform. The PTI Platform is a complementary portfolio of monoclonal antibodies, antibody-targeted vaccines and immunomodulators used in optimal combinations to create novel disease-specific drug candidates. For more information, please visit http://www.celldextherapeutics.com.
Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995: This release contains "forward-looking statements" made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including those related to the Company's strategic focus and the future development and commercialization (by Celldex and others) of Rindopepimut (PF-04948568 or CDX-110), CDX-1307, CDX-011, CDX-1135 (formerly TP10), CDX-1401, CDX-1127, Belinostat and other products. Forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to obtain additional capital on acceptable terms, or at all; our ability to adapt APC Targeting TechnologyTM to develop new, safe and effective vaccines against oncology and infectious disease indications; our ability to successfully complete product research and further development of our programs; our development partners' willingness to make announcements with respect to co-developed products; the uncertainties inherent in clinical testing; our ability to manage research and development efforts for multiple products at varying stages of development; Pfizer's and our strategy and business plans concerning the continued development and commercialization of Rindopepimut (PF-04948568 or CDX-110); the timing, cost and uncertainty of obtaining regulatory approvals; the failure of the market for the Company's programs to continue to develop; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; our ability to successfully integrate the businesses, multiple technologies and programs of CuraGen and Celldex; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission, including the Company's Form 10-K for the fiscal year ended December 31, 2009, and its Forms 10-Q and 8-K.
All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise.
Contacts:
Celldex Therapeutics, Inc.
Anthony S. Marucci, 781-433-0771
President and CEO
or
Avery W. Catlin, 781-433-0771
Chief Financial Officer
IR@celldextherapeutics.com
or
For Media:
BMC Communications Group
Matthew Driscoll, 212-477-9007 x20
mdriscoll@bmccommunications.com
© 2010 Business Wire
Antisoma announces presentation at ASCO
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
ASCO Live Blog: Saturday
By Adam Feuerstein
http://www.thestreet.com/story/10773728/1/asco-live-blog-saturday.html?cm_ven=GOOGLEN
Array BioPharma's ARRY-520 Well Tolerated ...
05.06.2010 15:05
http://www.finanznachrichten.de/nachrichten-2010-06/17080063-array-biopharma-s-arry-520-well-tolerated-and-demonstrates-preliminary-activity-as-a-single-agent-in-multiple-myeloma-patients-004.htm
Array BioPharma's ARRY-520 Well Tolerated and Demonstrates Preliminary Activity as a Single Agent in Multiple Myeloma Patients
Array BioPharma Inc. (NASDAQ: ARRY) today announced the presentation of positive Phase 1 clinical data for its novel kinesin spindle protein (KSP) inhibitor, ARRY-520. The data, which were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois, indicate that ARRY-520 was well tolerated and has shown encouraging preliminary results in the treatment of multiple myeloma. ARRY-520 is a novel, first-in-class, highly potent, selective KSP inhibitor currently advancing into a single-agent Phase 2 clinical trial and combination trials in patients with multiple myeloma. The poster is available as a PDF on Array's website at www.arraybiopharma.com.
"Although KSP inhibitors have not been explored to date in myeloma, the early data from this study are yielding interesting and exciting results," said Sagar Lonial, MD, Associate Professor, Vice Chair of Clinical Affairs, Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University School of Medicine. "Among a very heavily pretreated and relapsed and refractory patient population, ARRY-520 is well tolerated, and has resulted in sustained stable disease or partial remissions in a large number of patients. Since many novel agents show modest activity as single agents in such a refractory population, the preliminary evidence of activity with a manageable toxicity profile for ARRY-520 suggests that this agent should be further explored in larger trials both alone and in combination with other anti-myeloma agents."
Phase I Trial of ARRY-520 in Relapsed/Refractory Multiple Myeloma (RR MM)
(Abstract #8132) - Saturday, June 5, 2010, 8 a.m.- noon CDT, South Hall A2
This Phase 1, open-label, multicenter, dose-escalation study was designed to evaluate the safety, pharmacokinetics and pharmacodynamics of ARRY-520 administered intravenously (IV) on Day 1 and Day 2 repeated every 14 days in patients with multiple myeloma. This ongoing study has enrolled 20 patients with relapsed or refractory multiple myeloma or plasma cell leukemia with at least two prior lines of therapy (including both a bortezomib and an IMiD-based regimen, unless refusing or ineligible for this therapy). The maximum tolerated dose of ARRY-520 as monotherapy was 1.25 mg/m2/day. With the addition of prophylactic granulocyte-colony stimulating factor (G-CSF), ARRY-520 has been well tolerated at dose levels up to 2 mg/m2/day; dose escalation with ARRY-520 and G-CSF is ongoing. Neutropenia has been the most commonly reported adverse event.
ARRY-520 has shown promising preliminary clinical activity as a single agent in this heavily pretreated patient population. Of 20 evaluable patients, one partial response has been observed in a patient with eight prior lines of treatment who has been on study for more than 13 months, and two unconfirmed minor responses also have been reported in patients who only recently started protocol therapy. Nine patients remain on study, five of whom have been treated for longer than 6 months. The Phase 2 portion of this study is planned to commence during the third quarter of calendar year 2010.
About Multiple Myeloma
According to the Multiple Myeloma Research Foundation, multiple myeloma (also known as myeloma or plasma cell myeloma) is a progressive hematologic (blood) disease. It is a cancer of the plasma cell, an important part of the immune system that produces immunoglobulins (antibodies) to help fight infection and disease. Multiple myeloma is characterized by excessive numbers of abnormal plasma cells in the bone marrow and overproduction of intact monoclonal immunoglobulin (IgG, IgA, IgD, or IgE) or Bence-Jones protein (free monoclonal light chains). Hypercalcemia, anemia, renal damage, increased susceptibility to bacterial infection, and impaired production of normal immunoglobulin are common clinical manifestations of multiple myeloma. It is often also characterized by diffuse osteoporosis, usually in the pelvis, spine, ribs, and skull. The estimated frequency of multiple myeloma is 5 to 6 new cases per 100,000 persons per year. Accordingly, in the United States, approximately 20,580 new cases were diagnosed in 2009. There were more than 66,000 Americans living with multiple myeloma in 2009.
About KSP Inhibition
KSP is essential for cell division, or mitosis, in proliferating cells such as tumor cells. Prolonged inhibition of KSP arrests cells in mitosis, resulting in cell death. KSP inhibitors are novel anti-mitotics that specifically target proliferating cells and therefore may avoid some non-specific side effects, such as neuropathy. Due to their distinct mechanism of action compared to microtubule-targeting agents, KSP inhibitors show activity in tumors resistant to these drugs, including taxanes.
About ARRY-520
ARRY-520 is a highly potent, selective KSP inhibitor that was designed to provide sustained mitotic arrest compared to other anti-mitotics. In preclinical studies of multiple myeloma, ARRY-520 monotherapy has superior anti-tumor activity compared to Velcade® (bortezomib) or Revlimid® (lenalidomide). Also, ARRY-520 combined with Velcade, including bortezomib-refractory models, showed synergistic activity in vivo and superadditive activity when combined with Revlimid. Apoptosis in myeloma cells treated with ARRY-520 requires loss of the short-lived survival protein Mcl-1, providing a likely mechanistic explanation for ARRY-520 activity. Further studies, including a single-agent Phase 2 study and combination trials in multiple myeloma, are planned.
About Array BioPharma
Array BioPharma Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of targeted small-molecule drugs to treat patients afflicted with cancer and inflammatory diseases. Our proprietary drug development pipeline includes clinical candidates that are designed to regulate therapeutically important target proteins and are aimed at significant unmet medical needs. For more information on Array, please go to www.arraybiopharma.com.
Forward-Looking Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about the potential for the results of ongoing preclinical and clinical trials to support further development, and regulatory approval or the marketing success, of a drug candidate, and our future plans to progress and develop our proprietary programs, including ARRY-520. These statements involve significant risks and uncertainties, including those discussed in our most recent annual report filed on form 10-K, in our quarterly reports filed on Form 10-Q, and in other reports filed by Array with the Securities and Exchange Commission. Because these statements reflect our current expectations concerning future events, our actual results could differ materially from those anticipated in these forward-looking statements as a result of many factors. These factors include, but are not limited to, our ability to continue to fund and successfully progress internal research and development efforts and to create effective, commercially viable drugs; our ability to effectively and timely conduct clinical trials in light of increasing costs and difficulties in locating appropriate trial sites and in enrolling patients who meet the criteria for certain clinical trials; risks associated with our dependence on third-party service providers to successfully conduct clinical trials within and outside the United States; our ability to achieve and maintain profitability and maintain sufficient cash resources; the extent to which the pharmaceutical and biotechnology industries are willing to in-license drug candidates for their product pipelines and to collaborate with and fund third parties on their drug discovery activities; our ability to out-license our proprietary candidates on favorable terms; risks associated with our dependence on our collaborators for the clinical development and commercialization of our out-licensed drug candidates; the ability of our collaborators and of Array BioPharma Inc. to meet objectives tied to milestones and royalties; our ability to attract and retain experienced scientists and management. We are providing this information as of June 5, 2010. We undertake no duty to update any forward-looking statements to reflect the occurrence of events or circumstances after the date of such statements or of anticipated or unanticipated events that alter any assumptions underlying such statements.
Contacts:
Array BioPharma
Tricia Haugeto, 303-386-1193
thaugeto@arraybiopharma.com
© 2010 Business Wire
...still in!
Should be carefull with your picks tho.. like CXM. Deep shoot in there! Are you still holding in CXM?
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=50940294
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
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.
Name change from "Canadian_Superior_Energy_Inc." to "Sonde_Resources_Corp."
Sonde Resources Corp. Announces Results of Its Annual and Special Meeting of Shareholders, Implementation of Share Consolidation
Date : 06/04/2010 @ 8:25AM
Source : MarketWire
http://ih.advfn.com/p.php?pid=nmona&article=43098146&symbol=SNG
Sonde Resources Corp. Announces Results of Its Annual and Special Meeting of Shareholders, Implementation of Share Consolidation
CALGARY, ALBERTA -- (Marketwire)
06/04/10
Sonde Resources Corp. (the "Company") (TSX: SNG) (NYSE Amex: SNG) is pleased to announce that the following matters put before the annual and special meeting of holders ("Shareholders") of common shares ("Common Shares") of the Company held on June 3, 2010 were approved:
1. the election of Marvin M. Chronister, Dr. James Funk, Kerry R. Brittain, Dr. William J.F. Roach, Gregory G. Turnbull and James H.T. Riddell as directors of the Company for the ensuing year;
2. the appointment of Deloitte & Touche llp as auditors of the Company;
3. the name change from "Canadian Superior Energy Inc." to "Sonde Resources Corp.";
4. the consolidation (the "Consolidation") of the issued and outstanding Common Shares on the basis of one post-Consolidation Common Share for every five pre-Consolidation Common Shares;
5. the adoption of a new shareholder rights plan of the Company;
6. the confirmation of the new By-Law Number 1 of the Company.
Accordingly, the Company has filed articles of amendment to implement the Consolidation and to change the name of the Company to "Sonde Resources Corp."
The Company expects that the post-Consolidation Common Shares will begin trading on the Toronto Stock Exchange on or about June 8, 2010 and on the NYSE Amex on or about June 7, 2010. The post-Consolidation Common Shares will trade on each exchange under the new symbol "SOQ".
Letters of transmittal with respect to the Consolidation were mailed to all registered Shareholders on May 7, 2010, copies of which are available on the System for Electronic Document Analysis and Retrieval (SEDAR) at www.sedar.com and the Electronic Data Gathering, Analysis and Retrieval (EDGAR) system at www.sec.gov. To receive certificates representing post-Consolidation Common Shares, registered Shareholders should follow the instructions set out in the letter of transmittal and send their certificates representing pre-Consolidation Common Shares, together with a properly executed letter of transmittal, to Valiant Trust Company, the registrar and transfer agent of the Company. Beneficial Shareholders should contact their nominees with any questions regarding the procedures applicable to them.
Following the Annual and Special Meeting of Shareholders today the Company made a presentation which is available on our new website www.sonderesources.com.
2010 Operational Highlights
-- After declining to a Q1 average of 2,779 boe/d, Company production
increased to 3,127 boe/d for the week ending May 19, under-pinned by a
significant oil and gas discovery in the Eaglesham Wabamun trend, which
came online in May producing 2.4 mmcf/d and 100 bbls/d.
-- Highlighting management's expectation that production growth will
continue in Q3, in early May the Company began completion and/or tie-in
operations on 23 previously-suspended wells, including a new well at
Westerose testing from combined Mannville-Glauc-Ellerslie zones at a
combined rate exceeding 4 mmcf /d.
-- Particularly encouraging from the winter program is a nearly 25%
increase to the Company's daily liquids production, highlighting the
potential management sees for positive near-term growth in Company-wide
oil and condensate production.
-- In Tunisia, the Company signed a rig commitment agreement to take
operational possession of the ENSCO 105 jack-up rig during the fourth
quarter of 2010 for drilling the Zarat 1-North appraisal well on the 7th
of November Block.
-- In Trinidad, the Company began evaluation of 7 new offshore lease blocks
that will be offered for bid in August.
-- The Liberty LNG regassification project is on budget and moving forward
with submission of a construction permit planned for late August of this
year. The Company continues to pursue possible joint ventures related to
this project.
Second Half 2010 Plans and Strategy
Western Canada
The Company is committed to increasing shareholder value on its nearly 400,000 gross acres of Western Canada holdings, with strong emphasis on growing high-value oil and condensate production. After a thorough review of these assets, management has identified an extensive list of behind-pipe, infill and step-out locations capable of supporting a multi-year development and growth program. The latter half of 2010 is expected to mark the beginning of a substantial increase in Western Canada development and exploration activity, with a three-part strategy focused on core properties at Drumheller, Kaybob-Windfall and Boundary Lake-Eaglesham:
-- Development of high value, low-risk/low-finding and development costs
behind-pipe and infill reserves to increase cash flow in support of our
Canada and international growth programs, and to increase the value of
proved and probable reserves (gas-oriented). Management has identified
approximately 60 locations that will be targeted in 2010 and during the
first half of 2011, with potential for adding 1,600 boe/d in new
production.
-- Growth in liquids production through re-development of existing oil
pools, with a focus on the Mannville "I" pool at Drumheller. Included in
this program are plans for re-stimulating low-rate or suspended wells,
infill drilling using horizontal wells and multi-stage frac technology,
and initiation of a waterflood program.
-- Growth in liquids production through exploration for and exploitation of
oil resource plays on existing lands. Included in this program are
"proof-of-concept" re-entry's of suspended wells owned by the Company,
followed by infill and step-out drilling where successful.
International
The Company is committed to capturing the high-impact growth potential of its Tunisia/Libya and Trinidad/Tobago offshore oil and gas assets, and its Liberty Natural Gas LNG project on the US East Coast. Proposed plans for 2010 and the first half of 2011 include:
-- Drilling of the Zarat 1-North appraisal well (offshore Tunisia) in late
Q4, with potential for significant value and reserve additions given
success.
-- Participation in development plans for our offshore Trinidad assets as
commissioned by our Operator partner for the block.
-- Submission of construction permits by Liberty Natural Gas with respect
to the Liberty LNG regassification project expected by late August,
2010.
Canadian Superior Energy Inc. is a Calgary, Alberta, Canada based diversified global energy company engaged in the exploration and production of oil and natural gas and in the development of a liquefied natural gas ("LNG") project. Its operations are located offshore Trinidad and Tobago, Western Canada, North Africa, and offshore Eastern United States. See Canadian Superior's website at www.cansup.com to review further detail on Canadian Superior's operations.
Boe Presentation - Production information is commonly reported in units of barrel of oil equivalent ("boe"). For purposes of computing such units, natural gas is converted to equivalent barrels of oil using a conversion factor of six thousand cubic feet to one barrel of oil. This conversion ratio of 6:1 is based on an energy equivalent conversion method primarily applicable at the burner tip and does not represent a value equivalency at the wellhead. Such disclosure of boes may be misleading, particularly if used in isolation. Readers should be aware that historical results are not necessarily indicative of future performance.
This news release contains "forward-looking information" (within the meaning of applicable Canadian securities laws) and "forward -looking statements" (within the meaning of the U.S. Private Securities Litigation Reform Act of 1995). Such statements or information are identified with words such as "anticipate", "believe", "expect", "plan", "intend", "potential", "estimate", "propose", "project" or similar words suggesting future outcomes or statements regarding an outlook. Such statements include, among others, those concerning the Company's anticipated operational plans and activities including our development and exploration program in Western Canada, the exploration, development and drilling programs in Trinidad and in Tunisia and Libya, future construction plans and the submission of construction permits at the Liberty LNG regassification project, the expected continued production growth and strategy of the Company, and the expectation of successful future results.
Such forward-looking information or statements are based on a number of risks, uncertainties and assumptions which may cause actual results or other expectations to differ materially from those anticipated and which may prove to be incorrect. Assumptions have been made regarding, among other things, operating conditions, management's expectations regarding future growth, plans for and result of drilling activity, availability of capital, and capital and other expenditures. Actual results could differ materially due to a number of factors, including, without limitation, operational risks in development, exploration and production; delays or changes in plans with respect to exploration or development projects or capital expenditures; the uncertainty of reserve and resource estimates, the uncertainty of estimates and projections in relation to production, risks affecting the Company's ability to execute projects and market oil and natural gas, risks inherent in operating in foreign jurisdictions, the ability to attract key personnel, including the hiring of a Chief Executive Officer, and the inability to raise additional capital. Additional assumptions and risks are set out in detail in the Company's Annual Information Form, available on SEDAR at www.sedar.com., and the Company's annual reports on Form 40-F or Form 20-F on file with the U.S. Securities and Exchange Commission.
Although the Company believes that the expectations reflected in the forward-looking information or statements are reasonable, prospective investors in the Company's securities should not place undue reliance on forward-looking statements because the Company can provide no assurance that such expectations will prove to be correct. Forward-looking information and statements contained in this news release is as of the date of this news release and the Company assumes no obligation to update or revise this forward-looking information except as required by law.
Contacts:
Canadian Superior Energy Inc.
Investor Relations
(403) 294-1411
(403) 216-2374 (FAX)
www.cansup.com
Canadian Superior Energy Inc.
Suite 3200, 500 - 4th Avenue S.W.
Calgary, Alberta, Canada
T2P 2V6
Euro plummets below $1.20
Friday June 4, 2010, 3:20 pm
http://finance.yahoo.com/news/Euro-plummets-below-cnnm-3471764825.html?x=0&sec=topStories&pos=1&asset=&ccode=
The euro fell to a fresh four-year low below $1.20 Friday, as investors cast fresh doubts on the European debt crisis and a global recovery after gloomy economic statements out of Hungary and a disappointing U.S. jobs report.
What prices are doing: The euro slipped as much as 1.6% against the dollar to $1.19721, a fresh four-year low for Europe's shared currency. It was the second day in a week that the euro's losses surpassed the four-year low in intra-day trading.
Meanwhile, the dollar fell 1.27% against the Japanese yen to ¥91.53.
What's moving the market: Hungary's bleak economic outlook is in the spotlight after key officials there said the central European country has a "grave situation" on its hands, a "slim chance of avoiding the Greek situation," and must focus on avoiding "sovereign default."
Hungary joined the European Union in 2004 but does not use the euro currency. That didn't stop the euro from falling after the news, as official comments urging fiscal consolidation in the country sparked fear once again about Europe's debt crisis.
After Hungary set the tone for the day, a disappointing U.S. jobs report further took the feet out from the stock market and accelerated the fall of the euro, said Phil Streible, a senior market strategist with futures broker Lind-Waldock.
Employers added 431,000 jobs in May, 411,000 of which were temporary Census positions, the Labor Department said. Economists were expecting the government to report an increase of 500,000 jobs, according to a survey by Briefing.com.
Negative sentiment about a global economy recovery following both events pushed the dollar higher and the euro lower. The dollar is viewed as a safe-haven investment so it often performs well in times of economic uncertainty. The euro is considered a riskier asset.
What analysts are saying: Traders consider the $1.20 mark a key technical level for the euro.
"It's a pretty big line in the sand, and you don't want to cross it," Streible said. He expects that if the euro were to close the day below $1.20 it would trigger a sell-off into the $1.17 to $1.18 range.
Concerns about economic instability in the euro zone have caused the region's currency to tumble more than 11% against the dollar since March, as risk-averse investors park their money in the U.S. currency.
Sunesis (SNSS): Voreloxin in AML, Market Share Estimate
June 4th, 2010
http://www.gekkowire.com/?p=3717
...das schreib ich jetzt mal lieber auf deutsch!
frei nach Asterix: die spinnen, die Amerikaner
erst ist Griechenland schuld (pleite)
dann ist es Portugal und Spanien
und nun soll also Ungarn schuld/pleite sein !???
IRRE
immer sind die anderen schuld -
? wie wäre es mal, in/vor der eigenen Haustür zu kehren ==> USA ?!
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.
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.
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.
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 - May 17, 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.
PPS in GBp
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ADR program
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
PPS in $
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Antisoma's AS1413 gains FDA Fast Track status for treatment of secondary acute myeloid leukaemia (AML)
Press Release Source: Antisoma plc
On Thursday June 3, 2010, 2:14 am EDT
http://finance.yahoo.com/news/Antisomas-AS1413-gains-FDA-iw-55357026.html?x=0&.v=1
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.
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.
Antisoma @ ASCO
http://www.antisoma.com/asm/media/press/pr2010/2010-05-17/
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.
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London, UK, Cambridge, MA, and Washington, DC: 19 April 2010
AACR presentations highlight potential of Antisoma drugs AS1413_and_AS1411
http://www.antisoma.com/asm/media/press/pr2010/2010-04-19/
London, UK, and Cambridge, MA: 3 June 2010
Antisoma's AS1413 gains FDA Fast Track status for treatment of secondary acute myeloid leukaemia
http://www.antisoma.com/asm/media/press/pr2010/2010-06-03/
**
** Antisoma has a Level_One_American_Depositary_Receipt (ADR) Program.
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
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
American Capital Ltd.’s stock plunges on analyst downgrade
Thursday, June 3, 2010, 12:13pm EDT
http://www.bizjournals.com/washington/stories/2010/05/31/daily32.html?surround=lfn
Shares of Bethesda-based private equity company American Capital Ltd. were down 13 percent in mid-day trading Thursday after Stifel Nicolaus analysts downgraded the company on concerns that bankruptcy was more likely.
American Capital (NASDAQ: ACAS) has been trying since November to restructure some $2.4 billion in debt and avoid Chapter 11 bankruptcy.
It announced Wednesday it was extending the deadline for its debt restructuring agreement to June 8 and reported preliminary results of its debt holder votes, which some analysts felt was well below what the company would need to reach an agreement to restructure its debt, Reuters reported.
“We believe the probability of bankruptcy has risen significantly,” Stifel analyst Greg Mason wrote in a note to clients, according to Reuters.
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 has a Level_One_American_Depositary_Receipt (ADR) Program.
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
Keryx Biopharmaceuticals Announces Upcoming Corporate Presentations
Date : 06/03/2010 @ 8:30AM
Source : PR Newswire
Stock : Keryx Biopharmaceuticals (MM) (KERX)
http://ih.advfn.com/p.php?pid=nmona&article=43080377&symbol=N^KERX
PR Newswire
NEW YORK, June 3
NEW YORK, June 3 /PRNewswire-FirstCall/ --
Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) today announced that Ron Bentsur, the Company's Chief Executive Officer, will be presenting at the following June Investor conferences:
Wednesday, June 9, 2010 – 1:20 p.m. EDT
9th Annual Needham Healthcare Conference
New York Palace Hotel
New York City
Thursday, June 10, 2010 – 9:00 a.m. EDT
Jefferies Global Life Sciences Conference
New York City
A live audio webcast of Mr. Bentsur's presentations will be accessible from the Investor Information page of the Company's Website at http://investors.keryx.com. An archived version of each webcast will be available following the conclusion of the live presentation.
ABOUT KERYX BIOPHARMACEUTICALS, INC.
Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of life-threatening diseases, including cancer and renal disease. Keryx is developing KRX-0401 (perifosine), a novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, and also affects a number of other key signal transduction pathways, including the JNK pathway, all of which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival. KRX-0401 has demonstrated both safety and clinical efficacy in several tumor types, both as a single agent and in combination with novel therapies. KRX-0401 is currently in Phase 3 clinical development for both refractory advanced colorectal cancer and multiple myeloma, and in Phase 1 and 2 clinical development for several other tumor types. Each of the KRX-0401 Phase 3 programs are being conducted under Special Protocol Assessment (SPA) agreements with the FDA. Keryx is also developing Zerenex(TM) (ferric citrate), an oral, iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. The Phase 3 clinical program of Zerenex in the treatment for hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease is being conducted pursuant to an SPA agreement with the FDA. Keryx is headquartered in New York City.
KERYX CONTACT:
Lauren Fischer
Director - Investor Relations
Keryx Biopharmaceuticals, Inc.
Tel: 212.531.5965
E-mail: lfischer@keryx.com
SOURCE Keryx Biopharmaceuticals, Inc.
Sunesis to Present at Upcoming Investor Conferences
Date : 06/03/2010 @ 7:30AM
Source : MarketWire
Stock : Sunesis Pharmaceuticals, Inc. (SNSS)
http://ih.advfn.com/p.php?pid=nmona&article=43079095&symbol=N^SNSS
SOUTH SAN FRANCISCO, CA -- (Marketwire)
06/03/10
Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS), a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the treatment of solid and hematologic cancers, today announced that Daniel Swisher, Chief Executive Officer of Sunesis, will present at three upcoming conferences:
9th Annual Needham Healthcare Conference
Wednesday, June 9 at 10:40 a.m. EDT
New York Palace Hotel, New York City
Jefferies 2010 Global Life Sciences Conference
Thursday, June 10 at 8:00 a.m. EDT
Grand Hyatt, New York City
ThinkEquity Mid Year Check-Up on Healthcare
Wednesday, June 16 at 11:30 a.m. EDT
The Princeton Club, New York City
A live webcast of the Jefferies presentation on June 10th will be available on the Sunesis website at http://ir.sunesis.com. A replay of that webcast will be archived on the "Calendar of Events" page in the Investors and Media section of the Sunesis website for two weeks following the presentation.
About Sunesis Pharmaceuticals
Sunesis is a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the treatment of solid and hematologic cancers. Sunesis has built a highly experienced cancer drug development organization committed to advancing its lead product candidate, voreloxin, in multiple indications to improve the lives of people with cancer. For additional information on Sunesis, please visit http://www.sunesis.com.
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.
Annual Report 2009
http://www.antisoma.com/asm/ir/reports/rep2009/ar2009/ar2009.pdf?t=popup
Interim Report for the six months to 31 December 2009
http://www.antisoma.com/asm/ir/reports/rep2009/ir2009/ir_2009.pdf?t=popup
Antisoma has a Level_One_American_Depositary_Receipt (ADR) Program.
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
Antisoma's AS1413 gains FDA Fast Track status for_treatment_of_secondary_acute_myeloid_leukaemia
Press Release Source: Antisoma plc
On Thursday June 3, 2010, 2:14 am EDT
http://finance.yahoo.com/news/Antisomas-AS1413-gains-FDA-iw-55357026.html?x=0&.v=1
LONDON, UK and CAMBRIDGE, MA--(Marketwire - 06/03/10) - Cancer drug developer Antisoma plc (LSE: ASM; USOTC: ATSMY) today announces that 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.
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 Communication
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. 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 UK and the US. Please visit www.antisoma.com for further information about Antisoma.
http://www.antisoma.com/
Pipeline: http://www.antisoma.com/asm/products/pipeline/
Partnering opportunities
Out-licensing
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
Antisoma's AS1413 gains FDA Fast Track status for treatment of secondary acute myeloid leukaemia
Press Release Source: Antisoma plc
On Thursday June 3, 2010, 2:14 am EDT
http://finance.yahoo.com/news/Antisomas-AS1413-gains-FDA-iw-55357026.html?x=0&.v=1
LONDON, UK and CAMBRIDGE, MA--(Marketwire - 06/03/10) - Cancer drug developer Antisoma plc (LSE: ASM; USOTC: ATSMY) today announces that 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.
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 Communication
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. 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 UK and the US. Please visit www.antisoma.com for further information about Antisoma.
http://www.antisoma.com/
Pipeline: http://www.antisoma.com/asm/products/pipeline/
Partnering opportunities
Out-licensing
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