- Cyclacel Pharmaceuticals shares tumbled in Thursday morning trading after the company announced its most advanced drug failed in a late-stage study testing it in elderly cancer patients.
- Sapacitabine, an oral therapy that aims to halt tumor cell division, did not improve overall survival in the Phase 3 SEAMLESS trial. Investigators administered either alternating doses of sapacitabine and decitabine —a myelodysplastic syndromes (MDS) drug owned by Eisai and licensed in the U.S. to Otsuka — or decitabine monotherapy to 491 patients aged 70 or older with acute myeloid luekemia (AML).
- There were some silver linings, however. Patients receiving Cyclacel's drug had higher rates of complete remission (CR), a secondary endpoint, and improved overall survival if they began the study with low white blood cell counts, which constituted about two-thirds of the participants.
Despite sapacitabine missing its primary endpoint, it doesn't look like Cyclacel has completely abandoned the drug for an AML indication. The company plans to release more complete data at a later medical conference and discuss that data with regulatory agencies in the U.S. and Europe, according to a Feb. 23 statement.
"Additional analysis of stratified and exploratory subgroups is warranted to identify patients who are most likely to benefit from treatment with the experimental arm," Hagop Kantarjian, the study's chair, said in the statement.
"In parallel with data analysis and regulatory discussions, we will reevaluate our continued investment in sapacitabine in hematological malignancies," Cyclacel's CEO Spiro Rombotis said. "Our clinical development strategy in oncology will now concentrate on our two ongoing, clinical programs in DNA damage response and transcriptional regulation, which include our area of historical expertise in CDK inhibitors."
Rombotis added his company should be able to fund operations and pipeline developments through 2018. Cyclacel reported cash and cash equivalents of $18 million as of Sept. 30, according to its most recent quarterly filing with the Securities and Exchange Commission.
Cyclacel is also testing the drug for a handful of other indications, including advanced solid tumors and MDS.
Company stock was down about 27% to $3.96 per share in Thursday morning trading.