Shares of Cyclacel Pharmaceuticals (CYCC) dropped as much as 75% on December 16, 2014 after the Data and Safety Monitoring Committee — DSMB — determined that the company's drug known as sapacitabine would not reach its primary endpoint of survival in patients with AML — Acute Myeloid Leukemia. The Phase 3 trial known as SEAMLESS enrolled up to 486 patients across multiple centers to test sapacitabine in these AML patients. 

The DSMB stated that the drug sapacitabine had no safety issues but would not reach significance in improved survival for these patients. Despite this finding the DSMB has stated that the phase 3 trial should continue as planned with the recruited patients. The trial will continue on to finish but we don't expect any dramatic results that will help Cyclacel's share price by any means. The measure of survival in the trial was the amount of deaths within a 6 month period. The DSMB board concluded that of the 247 deaths in the trial , about 70% — 173 patients — died within the first 6 months of the trial. 

Acute Myeloid Leukemia is a blood cancer that starts in the bone marrow where blood cells are produced. Sapacitabine Cyclcacel's drug would have been a great drug for these patients as it was an oral therapy regimen — patients could take a pill by mouth. This compares to other chemotherapy treatments that require intravenous administration — administration through the skin and into the body. We believe that investors should stay away for the time being unless they are going to attempt to trade the stock. This phase 3 setback is not good for any long term holder and we don't see the final data boosting the share price since the primary endpoint of survival won't be met regardless. In fact, additional bad news could tank the share price even further.