The MDS Beacon™

Researchers yesterday presented interim results of an ongoing Phase 2 clinical trial of sapacitabine.  The clinical trial is being conducted with myelodysplastic syndromes (MDS) patients who are resistant to treatment with Vidaza (azacitidine) or Dacogen (decitabine).  Researchers presented the trial results at the American Society of Clinical Oncology (ASCO) 2010 annual meeting in Chicago.

Sapacitabine is a new drug being developed by Cyclacel Pharmaceuticals as a potential treatment for MDS and acute myeloid leukemia.  Sapacitabine damages the DNA of cancer cells and prevents the cells from multiplying.

The trial results presented at the ASCO meeting were based on data for 61 people age 60 or older who had higher-risk MDS and who had previously been treated with Vidaza or Dacogen. The trial participants were evenly divided to test one of three dosing regimens of sapacitabine.

When the scientists followed up on the trial participants at an average of five months later, two participants had achieved a complete response, and seven additional participants had improved blood counts.

Participants from all three dosing regimens responded to the new treatment, but the greatest number of responding participants were treated with the following dosing regimen: 300 milligrams of sapacitabine twice daily for seven days, every three to four weeks. Thirty-five percent of participants within the group who received that dosing regimen responded. All the participants who responded to sapacitabine did so within five cycles of treatment. The median time to response was one to two cycles.

The most common side effects included fatigue, nausea, and diarrhea. Four trial participants died within 30 days of the start of the trial, with one death “considered to be possibly related to sapacitabine,” according to the ASCO abstract.

All of the tested sapacitabine regimens seem to be safe treatments, concluded researchers.

For more information on the results presented at ASCO, please see abstract 6528 on the ASCO Meeting website.