Posts Tagged ‘myeloid’

Antisoma plc (LSE: ASM; USOTC: ATSMY) announces that it has started a randomised, controlled, multi-territory, phase IIb trial of AS1411 in patients with acute myeloid leukaemia (AML). Dr Ursula Ney, Chief Operating Officer of Antisoma, said: "AML is a devastating disease for which new treatment options are desperately needed. This phase IIb trial builds on earlier positive phase II findings, and is designed to ... Full story

ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) announced that its investigational pan-BCR-ABL inhibitor, AP24534, has been granted orphan drug designation by both the U. S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). In the U.S., the orphan designation of AP24534 is for the treatment of chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) and in the E.U., its orphan ... Full story

Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS) announced that it has completed formal End-of-Phase 2 meetings with the U.S. Food and Drug Administration (FDA) related to its lead compound, voreloxin, in acute myeloid leukemia (AML). Sunesis has received feedback and guidance from the FDA in response to proposed plans for further development of voreloxin in the treatment of AML. Based on the development clarity achieved as a ... Full story

Doctors can now understand better chronic myeloid leukaemia (CML), including how it responds to therapy, thanks to a new mathematical model for the disease, developed by scientists in Portugal, Belgium and the United States. The work, to be published in the June edition of the journal Haematologica, also reveals that current therapies which are not believed to cure CML with the right protocol can actually ... Full story

Novartis announced that Tasigna® (nilotinib) has been granted priority review by the US Food and Drug Administration (FDA) for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase. FDA priority review status is granted to therapies that offer major advances in treatment or provide a treatment where no adequate therapy exists. This status accelerates the ... Full story

Novartis announced that Tasigna® (nilotinib) 200 mg capsules has been granted priority review by the US Food and Drug Administration (FDA) for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase. FDA priority review status is granted to therapies that offer major advances in treatment or provide a treatment where no adequate therapy exists. ... Full story

The European Medicines Agency (EMEA) recommends orphan drug status for Aprea's treatment of acute myeloid leukemia (AML). The treatment is currently undergoing a Phase I clinical study and a final decision from the European Commission regarding status is expected in a few weeks. Aprea is part of the Karolinska Development portfolio. "Aprea is developing a new class of anticancer drugs for the treatment ... Full story

The National Institute for Health and Clinical Excellence (NICE) is currently appraising the use of dasatinib (made by Bristol Myers-Squibb) and nilotinib (Novartis) for chronic myeloid leukaemia in patients whose treatment with imatinib has failed due to resistance and/or intolerance. As with all NICE appraisals, an independent committee of experts and lay people considered evidence presented by the manufacturers of the medicines being appraised...... Full story

In a large Phase III clinical trial, Tasigna® (nilotinib) demonstrated greater efficacy over Glivec® (imatinib) in the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase... Go to Source Full story

Ambit Biosciences Corporation announced the enrollment and dosing at the University of Texas M. D. Anderson Cancer Center of the first patient in the ACE (AC220 Monotherapy Efficacy) Phase 2 pivotal trial in patients with relapsed or refractory acute myeloid leukemia (AML). AC220 is a novel, orally available, potent and highly selective small molecule that was specifically designed as a FMS-like tyrosine kinase-3 (FLT3) inhibitor. ... Full story