ChemGenex Pharmaceuticals Limited (ASX:CXS) announced yesterday
the presentation of updated clinical data showing that OMAPRO™
(omacetaxine mepesuccinate) produced durable hematologic and
cytogenetic responses in a significant proportion of chronic phase
chronic myeloid leukemia (CML) patients, who had failed previous
attempts to control their disease with two or three FDA-approved
tyrosine kinase inhibitors (TKIs). The new data were presented at
the 52nd Annual American Society of Hematology Meeting in Orlando,
Florida (ASH).
At the CML therapy poster session Dr. Jorge Cortes MD, Chair,
CML Section, Department of Leukemia, Division of Cancer Medicine,
The University of Texas MD Anderson Cancer Center, Houston, Texas,
and a lead investigator in ChemGenex’s clinical studies, presented
a poster on behalf of ChemGenex and a team of investigators from
leading international clinical research centers concluding that
OMAPROTM represents a new potential therapy for patients with
multi-TKI resistant CML.
Data were presented from 61 evaluable CML patients in chronic
phase (defined as those who had been adjudicated by an independent
Data Monitoring Committee (DMC) and had a bone marrow report
available for cytogenetic assessment). Highlights of the data
were:
- Major cytogenetic response (MCyR) rate
of 33% in patients who had failed 2 TKIs – these patients failed
imatinib and were also resistant to dasatinib or nilotinib
- MCyR rate of 20% in patients that had
failed 3 TKIs – these patients failed imatinib and were also
resistant to dasatinib and
nilotinib
Data were also presented from the complete group of 85 chronic
phase CML patients analyzed on an intent to treat (ITT) basis.
Highlights of the data were:
- Overall MCyR rate of 20% with a median
duration of response of 7.4 months (range 0.9 - 26+)
- Overall Complete hematological response
(CHR) rate of 73% with a median duration of 8.2 months (range 0.7 -
42+)
- Median Overall Survival of 30
months
The most commonly reported (>5%) grade 3/4 treatment-emergent
adverse events in the larger, 85 CML chronic phase ITT population
were thromobocytopenia (64%), anemia (34%), neutropenia (47%),
febrile neutropenia (14%), leukopenia (21%), lymphopenia (18%),
pancytopenia (9%) and bone marrow failure (11%) and fatigue (5%).
Grade 3/4 events were infrequent and managed by decreasing the days
of dosing per cycle.
“We are very pleased with the data presented today that reveals
the potential clinical benefit OMAPROTM could have for a
significant number of CML patients who, at present, have very
limited treatment options,” said Greg Collier, Ph.D., Managing
Director and Chief Executive Officer of ChemGenex. “We would like
to thank Dr. Cortes and all of our investigators for their efforts
to produce this data.
ChemGenex plans to file a New Drug Application for OMAPROTM for
the treatment of CML patients who have failed two or more approved
TKIs.
About the Poster
Abstract 2290. “Subcutaneous Omacetaxine (OM) Treatment of
Chronic Phase (CP) Chronic Myeloid Leukemia (CML) Patients
Following Multiple Tyrosine Kinase Inhibitor (TKI) Failure”. Poster
Session: Chronic Myeloid Leukemia - Therapy: Poster II presented on
Sunday, December 5, 2010 at 6:00 p.m.- 8:00 p.m. U.S. Eastern Time.
The location is Hall A3/A4 (Orange County Convention Center) Poster
Board II-170.
About the Analysis
This analysis was based on data from existing Phase 2 clinical
trials. Studies CGX-CML-202 and CGX- CML-203 were designed to
evaluate the safety and efficacy of subcutaneously (SC)
administered omacetaxine in patients who; (a) failed imatinib and
had the T315I mutation, or (b) were intolerant to two or more TKIs
respectively. Both studies are fully enrolled. Eligible patients
were adult CML patients in chronic, accelerated, or blast disease
phase (CP, AP, BP). Patients were given 1.25 mg/m2 SC omacetaxine
twice daily for 14 days every 28 days until hematologic response
for induction therapy. For maintenance therapy, patients were dosed
1.25 mg/m2 SC omacetaxine twice daily for 7 days every 28 days.
Eighty five patients in chronic phase were described in this
presentation. The median age was 61 years (26-83) with a median CML
disease duration of 73 months (3-234) in CP.
About OMAPRO™ (omacetaxine mepesuccinate)
Omacetaxine mepesuccinate is administered subcutaneously and
acts differently from TKIs. It may have a therapeutic advantage for
patients who have failed currently approved 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).
Omacetaxine 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
up-regulated 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 in 2009, demonstrated that omacetaxine kills human CML stem
cells that are known to be insensitive to TKIs.
Omacetaxine mepesuccinate is an investigational drug and not
approved for market in any jurisdiction.
About Chronic Myeloid Leukemia (CML) and TKI Failure
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 CML patients initially respond well to
treatments with drugs called tyrosine kinase inhibitors (TKIs).
However, significant proportions of patients fail or become
intolerant to, one or more TKIs and this has created a significant
unmet medical need in the management of CML.
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. A New Drug
Application is under review by the U.S. Food and Drug
Administration and a Marketing Authorisation Application is under
review by the European Medicines Agency for CML patients who have
failed imatinib therapy and have the Bcr-Abl T315I mutation. An
additional New Drug Application is in preparation for CML patients
who have failed two or more currently approved tyrosine kinase
inhibitors. ChemGenex has established a corporate alliance with
Hospira to develop and commercialize omacetaxine in Europe, the
Middle East and parts of Africa, and is seeking to establish
commercial partnerships in the rest of the world. ChemGenex plans
to commercialize omacetaxine itself in North America. ChemGenex
trades on the Australian Securities Exchange under the symbol
"CXS". For additional information on ChemGenex Pharmaceuticals,
please visit the Company’s website at http://www.chemgenex.com.
OMAPRO™ is a trademark of ChemGenex Pharmaceuticals Limited.
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are subject to a number of uncertainties that could change the
results described in the forward-looking statements. Investors
should be aware that there are no assurances that results will not
differ from those projected.
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