Pipeline updates are highly awaited events in the pharma/biotech sector as they play an important role in deciding whether or not to invest in a particular company. These updates provide information on candidates and at times give an insight into the commercial potential of the candidate once it is successfully developed and commercialized.
Late last week, Cyclacel Pharmaceuticals, Inc. (CYCC) provided an update on its cancer candidate, sapacitabine. The company said that the independent Data and Safety Monitoring Board (DSMB) has completed its fourth planned safety review for the phase III SEAMLESS study evaluating its lead pipeline candidate sapacitabine. Post review, the DSMB recommended that the study can go on as planned with no modifications required.
The DSMB found no concerns pertaining to the efficacy and safety of sapacitabine after reviewing the data currently available. The DSMB will conduct an interim futility analysis after 50% of the required events have been observed.
The randomized and registration-directed SEAMLESS study is evaluating the use of oral sapacitabine in elderly patients (above 70 years) suffering from acute myeloid leukemia (AML) for whom intensive chemotherapy is not recommended.
The study is being conducted under the FDA's Special Protocol Assessment (SPA) program with the primary endpoint being overall survival. Cyclacel expects to complete enrollment for the study in the next few months.
Apart from AML, Cyclacel is developing sapacitabine for other indications including myelodysplastic syndromes (MDS), chronic lymphocytic leukemia and solid tumors. The company is conducting a feasibility assessment of a phase IIb study on sapacitabine in older patients suffering from MDS who have failed hypomethylating agents.
Cyclacel carries a Zacks Rank #3 (Hold). Some better-ranked biotech stocks include Ligand Pharmaceuticals Inc. (LGND), Medivation Inc. (MDVN) and Auxilium Pharmaceuticals, Inc. (AUXL). While Ligand and Medivation are Zacks Rank #1 (Strong Buy) stocks, Auxilium holds a Zacks Rank #2 (Buy).
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