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Cyclacel Pharmaceuticals Management Discusses Q2 2012 Results - Earnings Call Transcript

With us today are Paul McBarron, Executive Vice President, Finance and Chief Operating Officer; and Dr. Judy Chiao, Vice President of Clinical Development and Regulatory affairs. As announced in today's press release, Spiro Rombotis, our President and Chief Executive Officer is on medical leave and will resume his duties in early September, 2012. Paul McBarron, our Executive Vice President of Finance and Chief Operating Officer will perform additional duties during Mr. Rombotis' medical leave including conducting this call.

At this time, I would like to turn the call over to Mr. Paul McBarron, our Executive Vice President, Finance and Chief Operating Officer.

Paul McBarron

Thank you, Corey and good afternoon, everyone. As mentioned by Corey I have been asked to temporarily assume some additional duties of Spiro's during his medical leave. We wish Spiro a rapid recovery and expect that he will resume his duties in early September. It is a pleasure to update you this afternoon on our corporate progress and financial results for the second quarter ended June 30, 2012.

First, we are pleased to report that during this last quarter, we continue to open new study sites in the U.S., bringing the total to 35 and enroll patients in the SEAMLESS Phase III trial. We're making steady progress in terms of enrollment towards the second planned periodic safety review to be performed by the independent Data Safety Monitoring Board, or DSMB, in late 2012 or early 2013.

As a reminder, SEAMLESS is a randomized Phase III registration-directed trial under a SPA, or Special Protocol Assessment agreement with the FDA, testing our lead product candidate oral sapacitabine capsules as frontline treatment in acute myeloid leukemia, or AML. SEAMLESS is expected to enroll approximately 485 elderly patients, aged 70 years or older, who are not candidates for, or have refused intensive induction therapy. There is a high unmet medical need for the treatment of elderly patients with AML, as the disease is associated with high mortality and poor quality of life. Currently, there is no standard treatment for this group of patients.

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