Navigation Links
ChemGenex's omacetaxine may provide first viable treatment option for highly resistant form of CML
Date:6/1/2009

MELBOURNE, Australia, and MENLO PARK, California U.S.A. (June 1st, 2009) ChemGenex Pharmaceuticals Limited (ChemGenex) (ASX:CXS) announced that the latest data from its pivotal study of omacetaxine in patients with T315I-positive chronic myeloid leukemia (CML) was the subject of an oral presentation and discussion today at the 2009 American Society of Clinical Oncology (ASCO) Annual Meeting in Orlando, Florida. The open label Phase 2/3 study (CGX-635-CML-202) investigated the use of omacetaxine, administered subcutaneously in CML patients who had failed imatinib and who have the highly drug resistant T315I kinase domain mutation.

Dr. Jorge Cortes, MD, Professor of Medicine and Deputy Chair in the Department of Leukemia at The University of Texas, MD Anderson Cancer Center, a lead investigator in the study, presented the data. Dr. Cortes said, "It appears that omacetaxine was well tolerated in this study and durable hematological and cytogenetic responses were observed in some CML patients with the T315I mutation." He added that "Several novel drugs have already been investigated in this difficult-to-treat population, but they have not had a reasonable risk:benefit ratio. These results suggest that omacetaxine may represent the first viable treatment option for this population of patients who currently have no established treatment options."

Data were presented from 66 patients: 40 in chronic phase, 16 in accelerated phase and 10 in blast phase. Highlights of the data were:

Chronic phase patients

  • Complete hematologic response (CHR) rate of 85% with a median response duration 8.9 months
  • Major cytogenetic response (MCyR) rate of 15% with a median response duration 6.1 months

Accelerated phase patients

  • CHR rate of 31% with a median duration 4.1 months
  • MCyR rate of 6% with a median response duration 1.8 months

Blast phase patients

  • CHR rate of 20% with a median duration 3.3 months

Tolerability

Investigators reported that omacetaxine is generally well tolerated, and that the most common side effect is reversible and transient myelosuppression.

Commenting on the presentation, Dr. Greg Collier, Chief Executive Officer and Managing Director of ChemGenex, said, "This is a very important milestone in the development of omacetaxine and in the evolution of ChemGenex. The data presented today will be provided to the FDA in the final part of our rolling NDA submission; this project remains on target for completion in Q3 this year." Dr. Collier finished by expressing his deep appreciation for patients and investigators who participated in this important trial.

Dr. Collier and ChemGenex's Chief Medical Officer Dr. Adam Craig will host an investor conference call and webcast to discuss the clinical results from both ASCO and the EHA Congress on Thursday 11th of June at 10 am AEST. Details of this event will be advised in coming days.

Omacetaxine Overview

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). As omacetaxine acts independently of tyrosine kinase inhibitors, it may have a therapeutic advantage for patients who have developed resistance to TKIs. Omacetaxine is administered subcutaneously.


'/>"/>

Contact: Joan Kureczka
Joan@kureczka-martin.com
415-821-2413
Kureczka/Martin Associates
Source:Eurekalert

Related medicine news :

1. Study provides hope that some transplant patients could live free of antirejection drugs
2. Study provides hope that some transplant patients could live free of anti-rejection drugs
3. Glades General Hospital First in Palm Beach County to Provide On-Site Electronic Birth Registration
4. Providence St. Joseph Medical Center, Caregivers Reach Agreement on a Union Contract
5. USAID Provides Additional Wildfire Assistance to Greece
6. MinuteClinic Becomes Participating Provider with Assurant Health
7. Over 500,000 Health Care Providers Now Cutting Costs, Saving Time Through CAQH Administrative Simplification Initiative
8. LifeMasters Provides Tips for Maintaining a Healthy Blood Cholesterol Level
9. New knock-out gene model provides molecular clues to breast cancer
10. Area Health Care Providers Announce Plans to Integrate Services
11. Crdentia Selected by High Rock Raceway to Provide Healthcare Staffing Services
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... (PRWEB) , ... June 26, 2016 , ... On June ... sponsor of the 2016 Cereal Festival and World’s Longest Breakfast Table in Battle Creek, ... of the city’s history as home to some of the world’s leading providers of ...
(Date:6/26/2016)... ... 2016 , ... PawPaws brand pet supplements owned by Whole Health ... the health of felines. The formula is all-natural and is made from Chinese herbs ... Cat Kidney Support Supplement Soft Chews are Astragalus Root Extract and Rehmannia ...
(Date:6/26/2016)... ... June 26, 2016 , ... ... they have been diagnosed with endometriosis. These women need a treatment plan to ... a comprehensive approach that can help for preservation of fertility and ultimately achieving ...
(Date:6/25/2016)... ... June 25, 2016 , ... Austin residents seeking Mohs surgery ... of Mohs Surgery and to Dr. Russell Peckham for medical and surgical dermatology. , ... for skin cancer. The selective fellowship in Mohs Micrographic Surgery completed by Dr. Dorsey ...
(Date:6/25/2016)... ... ... "With 30 hand-drawn hand gesture animations, FCPX users can easily customize each ... Film Studios. , ProHand Cartoon’s package transforms over 1,300 hand-drawn pictures into hand ... select a ProHand generator and drag it above media or text in the Final ...
Breaking Medicine News(10 mins):
(Date:6/26/2016)... , June 26, 2016 One of ... has announced the formation of a new biotechnology company, Noxopharm Limited ... $6m in an IPO and to list on the ASX. ... candidate, NOX66, ready to enter a Phase 1 clinical study later ... designed to address one of the biggest problems facing cancer patients ...
(Date:6/26/2016)... , June 27, 2016 Jazz Pharmaceuticals ... waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of ... acquisition of Celator Pharmaceuticals, Inc. ("Celator"; Nasdaq: ... p.m. (Eastern Daylight Time). As previously announced ... into a definitive merger agreement under which Jazz Pharmaceuticals ...
(Date:6/26/2016)... , June 27, 2016  VMS Rehab Systems, Inc. ... will take whatever measures required to build a strong ... which is currently listed on the OTC Markets-pink current ... Chairman and CEO, "We are seeing an anomaly in ... understand, not only by the Company, but shareholders and ...
Breaking Medicine Technology: