SynriboTreatment for Chronic Myelogenous Leukemia
Update: Synribo (omacetaxine) Now FDA Approved - October 26, 2012
NDA Submitted for Omapro
ChemGenex Submits New Drug Application for Omapro (omacetaxine Mepesuccinate) to U.S. FDA
MELBOURNE, Australia, and MENLO PARK, California U.S.A. (9th September 2009) – ChemGenex Pharmaceuticals Limited announced today the completion of its New Drug Application (NDA) submission to the U.S. Food & Drug Administration (FDA) for Omapro (omacetaxine mepesuccinate). Omapro is being developed for the treatment of patients with chronic myeloid leukemia (CML) who have failed treatment with imatinib and who have developed the Bcr-Abl T315I mutation. Imatinib, a tyrosine kinase inhibitor (TKI), is the first-line standard of care for patients with CML. Omapro is a first-in-class cetaxine which works differently from imatinib, and the second-line TKIs nilotinib and dasatinib.
Omapro has received Orphan Drug designation in the U.S. and in the European Union, and has received fast track status from the FDA. Omapro demonstrated clinical benefit in the pivotal Study 202, in CML patients who had failed imatinib and have the T315I mutation. Interim data were recently presented at the American Society of Clinical Oncology Annual Meeting.
"If approved, Omapro would be the first treatment specifically indicated for CML T315I patients, many of whom have no therapeutic options," said Adam R. Craig MD, PhD, Senior Vice President and Chief Medical Officer. "We thank the investigators, their research staff and patients for participating in the pivotal study."
If the FDA grants priority review for Omapro the examination period is expected to be approximately six months. If approved for marketing by the FDA following priority review, the launch of Omapro would be scheduled for mid-2010.
Greg Collier PhD, ChemGenex’s Chief Executive Officer and Managing Director, said, "The submission of the NDA for Omapro is a major milestone in the development of this novel product and we are now one step closer to delivering a new treatment for patients in an area of unmet medical need. This submission is a significant achievement in our strategic goal to commercialize Omapro independently in the U.S. oncology market."
About Chronic Myeloid Leukemia (CML) and the Bcr-Abl T315I Mutation
Chronic myeloid leukemia (CML) is a cancer of the bone marrow with a worldwide prevalence of approximately 200,000 patients. The bone marrow is responsible for the production of specialized cells that constitute blood; these cells include red blood cells (to carry oxygen around the body), thrombocytes (to help stop bleeding) and certain white cells (part of the body’s defense system against infection). In patients with CML the cell production system is diseased and defective. Cells multiply uncontrollably and do not fully develop (differentiate) into functional blood cells.
The majority of newly diagnosed CML patients initially respond well to treatments with drugs called tyrosine kinase inhibitors (TKIs). However, a significant proportion of patients fail or become intolerant to one or more TKIs. In many of these situations the cause of failure can be traced to the emergence of Bcr-Abl mutations. A common mutation called T315I renders CML resistant to all currently approved TKIs, and has created a significant unmet medical need in the management of CML.
About Omapro (omacetaxine mepesuccinate)
Omacetaxine is administered subcutaneously and acts differently from TKIs. It may have a therapeutic advantage for patients who have failed TKIs. Omacetaxine is currently in global phase 2/3 clinical trials for CML and has been granted Orphan Drug designations by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMEA) as well as Fast Track status by the FDA.
Omacetaxine mepesuccinate is a first-in-class cetaxine with demonstrated clinical activity as a single agent in a range of hematological malignancies. Omacetaxine has a novel mechanism of action, specifically binding to the ribosomal A-site cleft and inhibiting protein translation of short-lived oncoproteins that are upregulated in leukemic cells (particularly Cyclin-D1, Mcl-1 and c-Myc). In addition, pre-clinical research presented at the 14th Congress of the European Hematology Association (EHA) in Berlin, Germany this summer, demonstrated that omacetaxine kills human CML stem cells that are known to be insensitive to TKIs.
About ChemGenex Pharmaceuticals Limited
ChemGenex is an oncology focused biopharmaceutical company developing small molecules with new mechanisms of action to treat malignancies with significant unmet medical needs. The company is developing omacetaxine, its lead product candidate, for the treatment of patients with Chronic Myeloid Leukemia (CML), Acute Myeloid Leukemia (AML), and Myelodysplastic Syndrome (MDS). A New Drug Application has been submitted to the U.S. Food and Drug Administration for CML patients with the Bcr-Abl T315I mutation. The corporate strategy for ChemGenex is to commercialize omacetaxine independently in North America and to establish commercial partnerships in the rest of the world. ChemGenex currently trades on the Australian Stock Exchange under the symbol "CXS"
Details on the clinical trials can be accessed from the following websites: http://www.clinicaltrials.gov/ct2/show/NCT00375219?term=homoharringtonine&rank=9 and email@example.com Rebecca Wilson Buchan Consulting Tel: +61 (0)3 9866 4722 Cell: + 61 (0)417 382 391 Email: firstname.lastname@example.org Remy Bernarda Blueprint Life Science Group Tel: +1.415.375.3340 x 2022 Cell: 415.203.6386 Email: email@example.com
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Posted: September 2009
- FDA Approves Synribo for Chronic Myelogenous Leukemia - October 26, 2012
- ChemGenex Announces alignment of European and US regulatory strategies for omacetaxine - January 6, 2011
- ChemGenex Completes pre-NDA Meeting with U.S. FDA and Clarifies Timing for Second New Drug Application for Omapro - October 5, 2010
- ChemGenex and U.S. FDA Agree on Potential Regulatory Pathway for Omapro - July 16, 2010
- ChemGenex Receives a Complete Response Letter from the FDA for Omapro - April 12, 2010
- U.S. Food and Drug Administration's Oncologic Drug Advisory Committee Recommends ChemGenex Validate a Diagnostic Prior to Approval of Omapro in Chronic Myeloid Leukemia Patients with T315I Mutation - March 24, 2010
- U.S. Food and Drug Administration (FDA) Sets 22 March for Oncologic Drugs Advisory Committee (ODAC) Meeting to Review Omapro - March 2, 2010
- Extreme Weather in Washington D.C. has Postponed the FDA's Oncologic Drugs Advisory Committee Meeting Scheduled for 10 February 2010 - February 9, 2010
- ChemGenex Pharmaceuticals Announces Omapro to be Reviewed by the FDA's Oncologic Drugs Advisory Committee for the Treatment of Adults with Chronic Myeloid Leukemia who have Failed Prior Therapy with Imatinib and have the Bcr-Abl T315I Mutation - December 17, 2009
- ChemGenex Announces FDA Accepts NDA for Omapro (Omacetaxine Mepesuccinate) and Grants the Filing Priority Review Status - November 10, 2009
- ChemGenex Announces Submission of Non-Clinical Section of Rolling NDA for Omacetaxine - July 1, 2008
- ChemGenex appoints VP Regulatory Affairs - Confirms Planned NDA Rolling Submission for Omacetaxine Following Meeting with U.S. FDA - April 14, 2008