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Cyclacel Announces Grants Of New U.S. & European Patents Covering Sapacitabine Used In Combination With HDAC Inhibitors

BERKELEY HEIGHTS, N.J., Feb. 12, 2013 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP) (Cyclacel or the Company), a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious disorders, today announced the issuance of U.S. Patent No. US 8,349,792 ('792) and European Patent No 2,101,790 ('790). Both patents include claims to combination treatment of sapacitabine, the Company's lead product candidate, with HDAC (histone deacetylase) inhibitors. The patents provide exclusivity until June 2029 and December 2027 respectively.

"The grants of the '792 and '790 patents are important enhancements of sapacitabine's intellectual property estate. They supplement sapacitabine's existing composition of matter, dosing regimen and combination treatment patent protection and support US and EU market exclusivity toward the end of the next decade," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "We are pursuing a broad intellectual property strategy providing us with a strong foundation to achieve our clinical and commercial objectives for sapacitabine and our other assets. As we continue to enroll SEAMLESS, our pivotal Phase 3 trial of sapacitabine as front-line treatment in elderly patients with acute myeloid leukemia (AML), we look forward to providing additional updates for sapacitabine this year, including Phase 2 data in myelodysplastic syndromes (MDS), AML preceded by MDS, and solid tumors."

The two patents include claims to combinations of sapacitabine and HDAC inhibitors, pharmaceutical compositions comprising sapacitabine and HDAC inhibitors, and methods of treatment using such compositions of proliferative disorders including leukemias, lymphomas, and lung cancer. HDAC inhibitors specifically claimed include belinostat (PXD101), dacinostat (LAQ824), entinostat (MS-275), mocetinostat (MGCD0103), pracinostat (SB939), romidepsin (depsipeptide), sodium butyrate, sodium valproate, tacedinaline (CI-994, PD-123654, GOE-5549, acetyldinaline), trichostatin A, vorinostat (SAHA or suberoylanilide hydramic acid), and valproic acid. Cyclacel published preclinical model data in 2010 demonstrating that sapacitabine works synergistically with histone deacetylase (HDAC) inhibitors to induce significant reductions in tumor cell growth in vitro and in vivo.

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