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Cyclacel Pharmaceuticals (NASDAQ: CYCC) is expecting safety data and full myelodysplastic syndromes (MDS) data by the end of this quarter from its Phase III “SEAMLESS” study of its clinical drug Sapacitabine, designed for front-line treatment of acute myeloid leukemia.
The SEAMLESS trial is an ongoing registration-directed trial in elderly patients aged 70 years or older with newly diagnosed AML who are not candidates for or have refused induction chemotherapy. The Food and Drug Administration (FDA) has granted Cyclacel Special Protocol Assessment (SPA) for the drug.
Sapacitabine has demonstrated potent anti-tumor activity in both blood and solid tumors in preclinical studies. In a liver metastatic mouse model, Sapacitabine was shown to be superior to Gemcitabine (marketed as Gemzar by Eli Lilly (LLY)) in delaying the onset and growth of liver metastasis.
Sapacitabine oral capsules are currently involved in the following:
- The SEAMLESS Phase III trial being conducted under a special protocol assessment with the FDA as front-line treatment of acute myeloid leukemia (AML) in the elderly.
- Phase II studies for MDS and solid tumors including lung cancer.
- Investigator-led studies such as a Phase II/III comparing Sapacitabine to low dose cytarabine as front-line treatment of elderly patients with AML or high risk MDS unfit for intensive chemotherapy, and a Phase II study in chronic lymphocytic leukemia.
In an October 15th press release, Cyclacel announced positive Phase II study results for Sapacitabine. The company reported that the drug nearly doubled the expected survival rate in elderly patients with MDS after front-line therapy failure. MDS saw good median overall survival rates — the median survival for combined arms was 291 days.
Cyclacel CEO Spiro Rombotis stated at the Lazard Healthcare Conference in November 13, 2012, “We will have Phase II data MDS fully published in early 2013.” This adds additional short term catalyst trade value to the stock that both traders and investors should consider.
Also worth consideration is Cyclacel’s patent infringement lawsuit against Celgene (NASDAQ: CELG) which will begin a Markman patent construction hearing on March 16th, 2013. While the final result from this litigation might not be known until the middle of 2014, the case so far looks favorable for Cyclacel. It’s possible that Cyclacel could receive damages upwards of $70M, at least according to another Seeking Alpha author.
Disclosure: Long CYCC
