Sign in Subscribe
Pharmaceutical industry

ChemGenex Pharmaceuticals Launches New Trial for Ceflatonin in Chronic Myeloid Leukemia Patients

Strategic Insights

— 1 min read

ChemGenex Pharmaceuticals has initiated a new international trial of its leukemia drug, Ceflatonin, targeting patients with chronic myeloid leukemia (CML) who have developed resistance to the current treatment, Gleevec. This trial follows the recent grant of orphan drug status to Ceflatonin by the United States regulatory authority, indicating that the drug may address a significant unmet medical need. The trial will be conducted at approximately 15 clinical centers globally, including the United States, France, and Germany. ChemGenex aims to file for registration with the US Food and Drug Administration by mid-2007.

Key Takeaways:

  • ChemGenex Pharmaceuticals has launched a new trial of Ceflatonin, a leukemia drug targeting patients with chronic myeloid leukemia (CML) resistant to Gleevec.
  • The trial will involve approximately 15 clinical centers globally, including the United States, France, and Germany.
  • Ceflatonin has been granted orphan drug status by the United States regulatory authority, indicating potential unmet medical need.
  • ChemGenex expects to file for registration with the US Food and Drug Administration by mid-2007.
  • The T315I mutation is the most common resistance to Gleevec, affecting most, if not all, CML patients.
  • Ceflatonin targets the T315I mutation, while Bristol Myers Squib's dasatinib targets patients with Gleevec resistance but is ineffective against those with the T315I mutation.
  • ChemGenex shares were steady at 42.5 cents at the time of the announcement.

Statistics:

  • Approximately 15 clinical centers globally will participate in the trial.
  • The trial targets patients with chronic myeloid leukemia (CML) who have developed resistance to the current treatment, Gleevec.
  • Ceflatonin's orphan drug status was granted by the United States regulatory authority.
  • ChemGenex expects to file for registration with the US Food and Drug Administration by mid-2007.
  • The T315I mutation affects most, if not all, CML patients.
  • Ceflatonin is the only drug in development targeting the T315I mutation.

Sources:

  • Asia Pulse, June 13, 2006
  • ChemGenex Pharmaceuticals Ltd (ASX:CXS), official announcement
  • United States regulatory authority, orphan drug status granted to Ceflatonin
  • US Food and Drug Administration, dasatinib approval

Read more