Antisoma zu alten Höhen ?
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Wertpapier: Sarossa Capital |
Cancer drug developer Antisoma plc announced that the US 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 US 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 US 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 US FDA and other regulators."
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.
Antisoma develops novel products for the treatment of cancer. The company has operations in the UK and the US.
http://www.pharmabiz.com/article/...sp?articleid=55825§ionid=
schaun'mer mal, ob die amis davon wind bekommen. :D
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AS1413 (amonafide L-malate, formerly Xanafide®)
AS1413 is a DNA intercalator that induces apoptotic signalling by blocking TopoII binding to DNA. Unlike classical TopoII inhibitors, a distinctive feature of AS1413 is its ability to evade PgP and related transporters responsible for multi-drug resistance. AS1413 is currently in phase III development in secondary AML.
Secondary AML (acute myeloid leukaemia)
AML is divided into two major categories, de-novo and secondary. AML is classified as secondary AML if it occurs as a result of a prior haematological disease or treatment with chemotherapy or radiation therapy or a combination of the two causes. In a phase II trial, treatment with AS1413 plus cytarabine resulted in a complete response rate of 38.6%, with an additional 3.4% showing CRi (complete response without recovery of blood cell count). This compares with CR rates of around 25% seen with standard treatment in similar AML patients enrolled in two large American studies. AS1413 is now in a phase III registration trial called ACCEDE. The ACCEDE trial compares AS1413 plus cytarabine with daunorubicin plus cytarabine in 450 patients
Latest presentation
AS1413 is distinct from daunorubicin and etoposide, poster presentation at AACR, Washington 2010
Pgp impacts on CR rates in AML, poster presentation at ASCO, Chicago 2010
AS1411
AS1411 has shown activity against a wide range of solid and blood cancer cell lines in preclinical experiments and could therefore have potential against a variety of human cancers. Clinical development is focused on acute myeloid leukaemia (AML).
AS1411 is an aptamer. This is a type of drug based on a short piece of DNA or RNA. However, unlike some other drugs based on these chemicals, aptamers work as conventional drugs, binding to a protein target by virtue of a fit with its three-dimensional structure. The term aptamer is derived from the Greek ‘aptos’ (to fit).
AS1411 has a structure that allows it to bind specifically to a protein called nucleolin, which is found on the surface of many cancer cells. Once bound, the AS1411 aptamer is taken into the cancer cell, where it causes death by apoptosis (programmed cell death).
A previous phase I trial of AS1411 in 30 patients with various advanced cancers reported no serious adverse events related to treatment and promising signs of anti-cancer activity were seen.
Latest presentations
AS1411 novel combinations and microarray, poster presentation at AACR, Washington 2010
Long-term outcomes of patients responding to AS1411 regimen, poster presentation at ASCO, Chicago 2010
ASA404
ATTRACT-1 phase III trial of ASA404 halted following interim analysis
29 March 2010, London, UK, and Cambridge, MA: www.antisoma.com/asm/media/press/pr2010/2010-03-29/
Antisoma plc (LSE: ASM; USOTC: ATSMY) announces that the planned interim analysis of data from the ATTRACT-1 phase III trial of ASA404 in previously untreated non-small cell lung cancer (NSCLC) has shown that continuation of the trial would be futile, as there is little or no prospect of demonstrating a survival benefit with ASA404 in this setting. The ATTRACT-1 trial will therefore be halted.
Press releases 2010
June 2010
06/03/2010 Antisoma's AS1413 gains FDA Fast Track status for treatment of secondary acute myeloid leukaemia
06/05/2010 Antisoma announces presentation at ASCO of new data supporting AS1413 and AS1411
Partnering opportunities
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
RSI über 70 bedeutet Powerzone...
Es geht imo erst richtig los !!!
Und die ASCO Investoren kaufen erst noch imo !
1. ASCO
2. Es stehen ja noch die zwei anderen Veranstaltungen an...
Die Chartindikatoren sind super...und das Volumen steigt von Tag zu Tag, zudem haben wir super News und einige Veranstaltungen stehen an.
Regulatory Story
Go to market news section
Company Antisoma plc
TIDM ASM
Headline Antisoma to present at 9th Annual Needham Life Sciences Conference and 4th Annual Jefferies Healthcare Conference in New York
Released 12:00 04-Jun-2010
Number HUG1421573
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 at http://www.antisoma.com/asm/media/webcast/
For live viewing of the webcast, it is recommended that viewers log on 15 minutes early in order to register and download any necessary software.
Enquiries:
Alison Saville
Senior Marketing and Communications Executive
Antisoma plc
+44 (0)20 3249 2100
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.
HUG#1421573
Jetzt überlege ich dem rollenden Zug doch noch hinterher zu rennen, oder nicht!?!
Glückwunsch an euch alle die es rechtzeitig geschafft haben!
(ein wenig neidisch bin ich ja leider doch scho)
Day's Range: 6.25 - 8.75 GBp
Last Trade: 8.16 GBp
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Mon Jun 7, 2010 11:06am EDT
http://www.reuters.com/article/idCNN0714001720100607?rpc=44
....
Among biotech stocks, British minnow Antisoma (ASM.L), whose stock plunged 70 percent in March when a lung cancer drug it was developing with Novartis failed in a Phase III trial, saw a partial revival in its fortunes on hopes for other drugs in earlier-stage development.
Shares in Antisoma, which presented updates on both AS1413 and AS1411 at ASCO, rose 19 percent.