Omacetaxine News and Research

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SVC112 molecule acts specifically against head and neck cancer stem cells

The red, tube-shaped flowers of the firecracker bush (Bouvardia ternifolia), native to Mexico and the American Southwest, attract hummingbirds.

8 Jan 2020

Chemistry researchers patent new method for making anti-leukemia compounds

Chemistry researchers at Oregon State University have patented a method for making anti-leukemia compounds that until now have only been available via an Asian tree that produces them.

21 Mar 2019

Drug combination targets pre-leukemia stem cells

Your body's blood cells are manufactured by hematopoietic stem cells in bone marrow. But just as regular, mature cells can become cancerous, so too can stem cells.

12 Sep 2018

Teva's SYNRIBO for injection receives FDA approval for home administration

Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) today announced that the U.S. Food and Drug Administration (FDA) has approved SYNRIBO® (omacetaxine mepesuccinate) for injection, for subcutaneous use, to include home administration, and also approved a related Medication Guide and Instructions for Use.

6 May 2014

FDA grants full approval of SYNRIBO for injection

Teva Pharmaceutical Industries Ltd. today announced that the U.S. Food and Drug Administration has granted full approval of SYNRIBO (omacetaxine mepesuccinate) for injection. This oncology portfolio product received an accelerated approval in October, 2012 with additional clinical trial data required to fulfill post marketing requirements set forth by the FDA.

13 Feb 2014

Iclusig gets FDA approval for two rare blood and bone marrow diseases

The U.S. Food and Drug Administration today approved Iclusig (ponatinib) to treat adults with chronic myeloid leukemia and Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), two rare blood and bone marrow diseases.

15 Dec 2012

Pfizer receives FDA approval for Synribo to treat chronic myelogenous leukemia

The U.S. Food and Drug Administration today approved Synribo (omacetaxine mepesuccinate) to treat adults with chronic myelogenous leukemia (CML), a blood and bone marrow disease.

29 Oct 2012

Cephalon intends to make takeover bid for ChemGenex

Cephalon, Inc. and ChemGenex Pharmaceuticals Limited today jointly announced that Cephalon's wholly-owned subsidiary, Cephalon CXS Holdings Pty Ltd, intends to make a takeover bid for ChemGenex.

29 Mar 2011

Cephalon signs convertible note subscription agreement with ChemGenex Pharmaceuticals

Today, Cephalon, Inc. announced the signing of a convertible note subscription agreement with ChemGenex Pharmaceuticals Limited, an Australian-based oncology focused biopharmaceutical company.

22 Oct 2010

ChemGenex agrees with FDA on potential regulatory path to progress OMAPRO for CML

ChemGenex Pharmaceuticals Limited announced today it has agreed with the U.S. Food and Drug Administration (FDA) on a potential regulatory path to progress OMAPRO™ (omacetaxine mepesuccinate) for the treatment of patients with Chronic Myeloid Leukemia (CML).

14 Jul 2010

ChemGenex reports positive safety findings from two OMAPRO clinical trials at ASCO 2010

ChemGenex Pharmaceuticals Limited announced that positive safety findings from a combined analysis of two clinical trials for its lead product candidate, OMAPRO™ (omacetaxine mepesuccinate), were presented today during a poster discussion session at the 2010 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.

7 Jun 2010

FDA issues complete response letter regarding the NDA for OMAPRO

ChemGenex Pharmaceuticals announces that the U.S. Food and Drug Administration's Office of Oncology Drug Products has issued a complete response letter regarding the new drug application for OMAPRO for the treatment of adults with chronic myeloid leukemia who have failed prior therapy with imatinib and have the Bcr-Abl T315I mutation.

12 Apr 2010

ChemGenex shares falter as FDA requests more data on new leukemia drug

ChemGenex Pharmaceuticals Ltd. Shares fell most in the last 16 years to AUD$0.44 following a concern raised by the US drug regulators – US FDA. The FDA requested on Monday for more uniform clinical test data before they review and consider approval of the company’s new leukemia drug.

23 Mar 2010

FDA's ODAC voted to review T315I mutation prior to approval of OMAPRO

ChemGenex Pharmaceuticals Limited announced today that the U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee voted 7-1 that a validated test to identify the T315I mutation should be reviewed by the FDA prior to approval of OMAPRO™ (omacetaxine mepesuccinate).

23 Mar 2010

ChemGenex Pharmaceuticals' OMAPRO review: FDA reschedules ODAC meeting to 22 March, 2010

ChemGenex Pharmaceuticals Limited announced today that the U.S. Food and Drug Administration (FDA) has rescheduled the previously postponed Oncologic Drugs Advisory Committee (ODAC) meeting to 22 March 2010.

1 Mar 2010

ODAC to conduct public advisory meeting to review ChemGenex Pharmaceuticals’ NDA for Omapro

ChemGenex Pharmaceuticals Limited announced today the U.S. Food and Drug Administration (FDA) has notified the company that the Oncologic Drugs Advisory Committee (ODAC) will conduct a public advisory meeting on 10 February 2010 to review the Company’s NDA for Omapro™ (omacetaxine mepesuccinate) for injection.

17 Dec 2009

ChemGenex Pharmaceuticals and Hospira enter into exclusive agreement

ChemGenex Pharmaceuticals Limited and Hospira, Inc. announced today that they have entered into an exclusive agreement to license, develop and commercialize ChemGenex’s product candidate omacetaxine mepesuccinate, a novel targeted cytotoxic pharmaceutical product, in Europe, the Middle East and parts of Africa (the Territory).

13 Dec 2009

Phase II clinical trial results reveal positive effects of omacetaxine against CML

Results from a phase II clinical trial indicate a novel drug may provide a treatment option for chronic myeloid leukemia (CML) patients who do not respond to current therapies, researchers from The University of Texas M. D. Anderson Cancer Center report today at the 51st Annual Meeting of the American Society of Hematology.

8 Dec 2009

ChemGenex Pharmaceuticals presents clinical results of Omapro drug at ASH meeting

ChemGenex Pharmaceuticals Limited (ASX:CXS) announced today updated clinical data showing that Omapro™ (omacetaxine mepesuccinate) produced durable hematologic and cytogenetic responses in chronic myeloid leukemia (CML) patients who have failed treatment with imatinib and who have developed the Bcr-Abl T315I mutation.

7 Dec 2009

New treatment options for leukemia and myeloproliferative disorders introduced

Leukemia and myeloproliferative disorders are serious and often deadly blood cancers. Research presented today at the 51st Annual Meeting of the American Society of Hematology introduces potential new treatment options and improved diagnostic methods for patients suffering from acute promyelocytic leukemia, chronic myeloid leukemia, infant acute lymphoblastic leukemia, and myelofibrosis that are based on a better understanding of the underlying genetic causes of these conditions.

6 Dec 2009