27 News by Antisoma

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27 News by Antisoma

Tip: You can further refine your news selection by topics, departments, countries and industries.

Antisoma's phase III trial of AS1413 completes patient enrolment

10-Sep-2010 - Antisoma plc announces that the ACCEDE phase III trial of AS1413 (amonafide L-malate) in secondary acute myeloid leukaemia (secondary AML) is now fully enrolled. Data from the trial are expected in the first half of 2011, with filings for marketing authorisations to follow if these are ...

chemotherapy drug resistance Fast Track status

Antisoma's AS1413 gains FDA Fast Track status for treatment of secondary acute myeloid leukaemia

04-Jun-2010 - Antisoma plc announced hat the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the Company's novel DNA intercalator, AS1413 (amonafide L-malate), for the treatment of secondary acute myeloid leukaemia (secondary AML). The FDA's Fast Track programme is designed to ...

Fast Track status food orphan drugs

Antisoma: ATTRACT-1 phase III trial of ASA404 halted following interim analysis

30-Mar-2010 - Antisoma plc announced 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 ...

lung cancer phase III studies

Antisoma initiates phase IIb trial of AS1411 in acute myeloid leukaemia

22-Mar-2010 - Antisoma plc announced that it has started a randomised, controlled, multi-territory, phase IIb trial of AS1411 in patients with acute myeloid leukaemia (AML). The phase IIb trial is enrolling patients with AML in first relapse or refractory to one prior treatment. Around 90 patients are being ...

chemotherapy oncology phase IIb studies

Antisoma's AS1413 regimen yields high response rate and durable responses in patients with secondary AML

08-Dec-2009 - Antisoma plc announced that positive final data from a phase II trial of AS1413 in patients with secondary acute myeloid leukaemia (secondary AML) were presented at the American Society of Hematology (ASH) meeting in New Orleans. Follow-up of patients has now been completed, and full results are ...

bone marrow hematology internal medicine

Antisoma's AS1411 gains US and EU Orphan Drug Status for acute myeloid leukaemia

16-Oct-2009 - Antisoma plc announces that its aptamer drug AS1411 has been granted orphan drug status in both the United States and the European Union for the treatment of acute myeloid leukaemia (AML). The grants will provide seven years of market exclusivity in the US and ten years of exclusivity in the EU ...

orphan drugs phase IIb studies

Antisoma's Phase III trial of ASA404 in lung cancer completes patient enrolment

01-Sep-2009 - Antisoma plc announced that the ATTRACT-1 phase III trial of ASA404 in non-small cell lung cancer (NSCLC) has reached its enrolment target of 1,200 patients. The trial is the single pivotal registration study for the drug as a first-line treatment for squamous and non-squamous NSCLC, and is ...

flow lung cancer phase III studies

Phase III development of Antisoma's ASA404 in lung cancer extended to Japan

27-Mar-2009 - Antisoma plc announced that ATTRACT-1, the Novartis phase III trial evaluating ASA404 as a first-line treatment for non-small cell lung cancer, is now enrolling patients in Japan. ATTRACT-1 has been enrolling patients in a variety of other countries since it began in April 2008. Extension of the ...

flow Japan lung cancer

Antisoma's ASA404 enters pivotal phase III trial in second-line lung cancer

15-Jan-2009 - Antisoma plc announced that 'ATTRACT-2', a phase III trial testing ASA404 as a second-line treatment for non-small cell lung cancer (NSCLC), is now underway. This is a single pivotal study designed to support applications to market ASA404 for lung cancer patients who have received one previous ...

chemotherapy histology lung cancer

Antisoma receives FDA approval for oral fludarabine, plans commercialisation deal to bring drug to US patients

23-Dec-2008 - Antisoma plc announced that the United States Food and Drug Administration (FDA) has approved its tablet formulation of fludarabine phosphate ('oral fludarabine') as a second-line treatment for chronic lymphocytic leukaemia (CLL). Oral fludarabine provides an alternative means to administer ...

food oncology phosphate
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