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Cyclacel Reports First Quarter 2013 Financial Results

Business Highlights

  • Announced updated median overall survival data from an ongoing, multicenter, Phase 2 randomized trial of oral sapacitabine in older patients with intermediate-2 or high-risk MDS after treatment failure of front-line hypomethylating agents, such as azacitidine and/or decitabine. Median overall survival to date for all 63 patients treated is approximately 9 months. Median overall survival for each of the three randomization schedules is approximately 10 months for Arm G, 10 months for Arm H and 8 months for Arm I. The 30-day mortality for all patients is 5%.  
  • Reported at the 104th Annual Meeting of the AACR, updated data from an open label, single arm, Phase 1 escalation trial of the Company's sapacitabine, a nucleoside analogue, and seliciclib, a cyclin-dependent kinase (CDK) inhibitor, as an all-oral, sequentially-administered regimen in heavily-pretreated patients with advanced solid tumors. To date, 38 patients with incurable solid tumors and adequate organ function have been enrolled, 16 of which were found to be BRCA mutation carriers. Four patients with BRCA-deficient, breast, ovarian and pancreatic cancers achieved confirmed partial responses with promising durability, with the longest lasting more than 78 weeks. Stable disease of 12 weeks or more was observed in eight additional patients, including two with BRCA-deficient, ovarian and breast cancers, lasting 64 weeks and 21 weeks, respectively. The AACR Annual Meeting Program Committee selected this study for inclusion at a press conference highlighting major developments reported during the AACR's 104 th Annual Meeting.  
  • Received $5.5 million from Celgene Corporation ("Celgene") for the sale of four Cyclacel romidepsin-related patents to Celgene and dismissal of all claims in the related patent litigation.  
  • Issued U.S. Patent 8,349,792 and European Patent 2,101,790 providing exclusivity until 2029 and 2027 respectively. Both patents include claims to combination treatment of sapacitabine with HDAC (histone deacetylase) inhibitors, compositions comprising sapacitabine and HDAC inhibitors, and methods of treating various cancers with such compositions, including leukemias, lymphomas and lung cancer.  
  • Issued an aggregate 1,513,653 common shares in exchange for an aggregate 792,460 preferred shares. 

First Quarter 2012 Financial Results

Research and Development Expenses

Research and development expenses in the first quarter of 2013 were $1.6 million compared to $1.3 million for the same period in 2012 with the increase of $0.3 million primarily due to clinical trial and manufacturing costs.

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