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news.US-based Cyclacel Pharmaceuticals has announced that the Japanese Patent and Trademark Office issued two patents broadening the exclusivity of its lead clinical candidate sapacitabine.
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Japanese Patent 5443763 claims new pharmaceutical formulations of sapacitabine, while Patent 5457196 claims methods of treating cancer comprising sapacitabine in combination with histone deacetylase (HDAC) inhibitors.
According to the company, equivalent patents have been granted in the US and other countries.
Cyclacel president and chief executive officer Spiro Rombotis said the Japanese patent grants further enhance the company’s sapacitabine intellectual property estate in one of the world’s top pharmaceutical markets.
"We have been executing on our patent lifecycle strategy for sapacitabine by building exclusivity in major global markets extending up to 2030," Rombotis said.
"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."
Sapacitabine is an orally-available nucleoside analogue and is currently being studied in SEAMLESS, an ongoing, Phase III, registration-directed trial carried out in elderly patients aged 70 years or older with newly diagnosed AML who are not candidates for or have refused induction chemotherapy.
The drug is in Phase II 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 I trial with seliciclib in patients with advanced solid tumors.
The FDA and the European Medicines Agency (EMA) have designated sapacitabine as an orphan drug for the treatment of both AML and MDS.