Cyclacel Announces Japanese Patents Issued Covering Sapacitabine Pharmaceutical Formulations

On May 5, 2014

Berkeley Heights-based Cyclacel Pharmaceuticals, Inc. has announced that the Japanese Patent and Trademark Office issued two patents broadening the exclusivity of sapacitabine, the company’s lead clinical candidate. Japanese Patent 5443763 claims novel pharmaceutical formulations of sapacitabine. Japanese Patent 5457196 claims methods of treating cancer comprising sapacitabine in combination with histone deacetylase (HDAC) inhibitors. Equivalent patents have been granted in the United States and other countries.

“The Japanese patent grants further enhance our sapacitabine intellectual property estate in one of the world’s top pharmaceutical markets,” said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. “We have been executing on our patent lifecycle strategy for sapacitabine by building exclusivity in major global markets extending up to 2030. We look forward to providing updates of our progress with sapacitabine, including the European expansion of SEAMLESS, our pivotal Phase 3 trial in front-line elderly AML, as well as our plans for a randomized, controlled trial in myelodysplastic syndromes. We expect SEAMLESS completion of enrolment around the end of this year with topline data readout around mid-2015.”

About sapacitabine

Sapacitabine (CYC682), an orally-available nucleoside analogue, is being studied in SEAMLESS, an ongoing, Phase 3, 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.

Sapacitabine is in Phase 2 trials in patients with hematological malignancies, including AML, myelodysplastic syndromes (MDS), cutaneous T-cell lymphoma (CTCL), chronic lymphocytic leukemia, small lymphocytic lymphoma, and also non-small cell lung cancer (NSCLC), and a Phase 1 trial with seliciclib in patients with advanced solid tumors.

Sapacitabine acts through a novel DNA single-strand breaking mechanism, leading to production of DNA double strand breaks (DSBs) and/or checkpoint activation. Unrepaired DSBs cause cell death. Repair of sapacitabine-induced DSBs is dependent on the homologous recombination

(HR) DNA repair pathway. Both sapacitabine and CNDAC, its major metabolite, have demonstrated potent anti-tumor activity in preclinical studies.

Over 800 patients have received sapacitabine in clinical studies in patients with AML, MDS, CTCL, NSCLC, hematological malignancies and solid tumors. At the 2012 American Society of Hematology (ASH) Annual Meeting, data from the pilot study and lead-in phase of SEAMLESS showed promising response rate, overall survival and low 30-day and 60-day mortality in elderly patients with AML aged 70 years or older receiving sapacitabine alternating with decitabine. Results from a randomized Phase 2, single-agent study of sapacitabine, including promising 1-year survival in elderly patients with AML aged 70 years or older, were published in The Lancet Oncology in November 2012.

At the 2013 American Association of Cancer Research (AACR) Annual Meeting data, from a Phase 1 study of sapacitabine in combination with Cyclacel’s seliciclib which showed antitumor activity in cancer patients found to be carriers of gBRCA mutations, was highlighted by the Annual Meeting Program Committee.

The FDA and the European Medicines Agency have designated sapacitabine as an orphan drug for the treatment of both AML and MDS. Sapacitabine is part of Cyclacel’s pipeline of small molecule drugs designed to target and stop uncontrolled cell division.

Cyclacel is a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious diseases. Sapacitabine, Cyclacel’s most advanced product candidate, is the subject of SEAMLESS, a Phase 3 trial being conducted under an SPA with the FDA as front-line treatment for acute myeloid leukemia (AML) in the elderly, and other studies for myelodysplastic syndromes (MDS), chronic lymphocytic leukemia (CLL) and solid tumors including breast, lung, ovarian and pancreatic cancer and in particular those carrying gBRCA mutations. Cyclacel’s strategy is to build a diversified biopharmaceutical business focused in hematology and oncology based on a development pipeline of novel drug candidates.

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