ChemGenex’s Omacetaxine Demonstrates 80% Complete Hematological Response Rate in Drug-Resistant CML Patients with the T315I...

  
    
  
  
    
      ChemGenex Pharmaceuticals (ASX: CXS) (NASDAQ: CXSP) announced today 
      positive interim clinical data from 44 patients enrolled in its ongoing 
      phase 2/3 trial of omacetaxine mepesuccinate in chronic myeloid leukemia 
      (CML) patients with the T315I mutation.
    
    
      Clinical investigators reported that subcutaneous omacetaxine was 
      generally well tolerated and demonstrated durable complete hematological 
      and cytogenetic responses in patients who had failed to respond to the 
      current front-line treatment, imatinib mesylate (Gleevec®), 
      and who have the T315I mutation. There are currently no effective drug 
      treatments for the increasing number of patients with the T315I 
      mutation, and it is acknowledged as an important therapeutic challenge 
      in the treatment of CML.
    
    
      Dr. Jorge Cortes, Professor of Medicine and Deputy Chair, Department of 
      Leukemia at The University of Texas, MD Anderson Cancer Center in 
      Houston, presented data today on behalf of a team including 
      investigators from ChemGenex and leading U.S. and European research 
      centers in a poster discussion session at the American Society of 
      Hematology (ASH) 50th Annual Meeting in San Francisco, 
      California.
    
    
      Data were presented from 44 patients: 25 in chronic phase, 11 in 
      accelerated phase and 8 in blast phase. Highlights of the data were:
    
    
      
        Complete hematologic responses (CHR) in 80% of chronic phase patients, 
        median response duration 11.5+ months (range 3.5-25.4+ months)
      
      
        Major cytogenetic responses (MCyR) in 20% of chronic phase patients, 
        median response duration 4.8+ months (range 0.3-9.7+ months)
      
      
        Progression Free Survival (PFS) rates for chronic phase patients of 
        80% at 1 year and 70% at 2 years
      
      
        Hematologic responses in 45% of accelerated phase patients (median 
        duration 9.6+ months) and 13% of blast phase patients
      
      
        Investigators reported that omacetaxine is generally well tolerated, 
        and that the most common side effect, reversible and transient 
        myelosuppression, rarely results in serious clinical complications
      
    
    
      "Omacetaxine continues to be a promising candidate for the treatment of 
      CML patients with the T315I mutation, a common mutation in patients who 
      have failed Gleevec® (imatinib) therapy and one for which 
      there are no available therapies,” said Dr. Cortes. “The clinical trial 
      data we have presented demonstrates the ability of omacetaxine to induce 
      durable clinical remissions in T315I+ CML patients and the elimination 
      of the T315I clone in the majority of patients studied.”
    
    
      T315I-positive patients represent a significant and growing unmet 
      medical need in CML, and omacetaxine continues to demonstrate impressive 
      clinical benefits for patients with this mutation,” said Dr. Greg 
      Collier, ChemGenex’s Managing Director and Chief Executive Officer. 
      “This data presentation at ASH is another significant milestone for the 
      company, being a strong indication of the data that will comprise the 
      clinical section of our New Drug Application (NDA) to the FDA next year. 
      We are on track to complete clinical trial enrollment by the end of this 
      year, and we anticipate completing our rolling NDA submission for 
      omacetaxine by mid 2009.”
    
    
      Gleevec®/Glivec® is a registered trademark of 
      Novartis AG.
    
    
      About ChemGenex Pharmaceuticals Limited (http://www.chemgenex.com)
    
    
      ChemGenex Pharmaceuticals is a pharmaceutical development company 
      dedicated to improving the lives of patients by developing personalized 
      oncology medicines. ChemGenex harnesses the power of genomics both to 
      discover novel targets and drug compounds, and in clinical trials to 
      develop more individualized treatment outcomes. ChemGenex’s lead 
      compound, omacetaxine mepesuccinate (formerly known as Ceflatonin®), 
      is currently in phase 2/3 clinical trials for chronic myeloid leukemia 
      (CML). ChemGenex has a second anticancer compound, amonafide 
      dihydrochloride (formerly known as Quinamed®) which is in 
      phase 2 clinical development for various solid cancers, and a portfolio 
      of assets in pre-clinical development. ChemGenex currently trades on the 
      Australian Stock Exchange under the symbol "CXS" and on NASDAQ under the 
      symbol "CXSP".
    
    
      Details on the clinical trials can be accessed from the following 
      websites;
    
    
      http://clinicaltrials.gov/ct2/show/NCT00375219?term=homoharringtonine&rank=9 
      and http://www.tkiresistantcmltrials.com
    
    
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