The US Patent and Trademark Office (USPTO) issued US Patent No. 8,124,593 ('593) to Cyclacel Pharmaceuticals, Inc., a biopharmaceutical company. The patent grants claims to a specified method of administration of sapacitabine, Cyclacel's lead drug candidate, with patent exclusivity until July 2030.
"The grant of the '593 patent is an important enhancement of sapacitabine's intellectual property estate. It extends existing composition of matter US patent protection and supports US market exclusivity out to 2030," 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 tumours."
The patent, titled "Methods of Treatment Using Sapacitabine", covers a method for treating proliferative diseases, including leukaemia, MDS, solid tumours and lymphoma, by administering sapacitabine using 7-day or 14-day dosing regimens in a 21-day cycle. The method includes once daily or twice daily dosing. The 7-day dosing regimen is being used in ongoing phase 2 studies of sapacitabine in second line MDS following previous treatment with one or more hypomethylating agents, in AML preceded by MDS and in phase 1 solid tumour studies. In addition to currently granted patents claiming sapacitabine composition of matter and specific dosage regimens, Cyclacel has multiple sapacitabine-related patent applications at the national stage of prosecution according to our strategy of protecting novel medical uses, combination therapies, alternative dosage regimens, pharmaceutical forms and synthetic routes.
Sapacitabine (CYC682), an orally-available nucleoside analogue, is currently being evaluated in SEAMLESS, a registration-directed, Phase 3 trial in elderly patients with newly diagnosed acute myeloid leukemia (AML), phase 2 trials in patients with haematological malignancies, including myelodysplastic syndromes (MDS), cutaneous T-cell lymphoma (CTCL), chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL), and non-small cell lung cancer (NSCLC) and in a phase 1 trial in combination with seliciclib in patients with advanced solid tumours. 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 DNA repair (HRR) pathway. Both sapacitabine and CNDAC, its major metabolite, have demonstrated potent anti-tumor activity in preclinical studies.
Over 350 patients have received sapacitabine in Phase 2 studies in AML, MDS, CTCL and NSCLC. Sapacitabine has been administered to approximately 170 patients in five Phase 1 studies with both hematological malignancies and solid tumors. In December 2009 at the Annual Meeting of the American Society of Hematology (ASH), Cyclacel reported data 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. In June 2011 at the Annual Meeting of the American Society of Clinical Oncology (ASCO), Cyclacel reported data from a pilot phase 1/2 study including promising response rate, low 4-week and 8-week mortality in elderly patients with AML aged 70 years or older receiving sapacitabine alternating with decitabine. 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.