This phase I study is designed to assess the safety, tolerability and preliminary efficacy of sphingosome encapsulated vinorelbine in patients with advanced solid tumors.
Hana is developing this compound for patients with non-small cell lung cancer and breast cancer, among others. The study is being conducted at the Cancer Therapy and Research Center in San Antonio and McGill University in Montreal.
“This trial affirms Hana Biosciences’ commitment to the continued advancement of promising product candidates with the potential to improve patient care,” said Dr Gregory Berk, the company’s chief medical officer. “We believe this novel product may allow for improved delivery and pharmaceutical attributes of vinorelbine, a well-established therapy for lung and breast cancer.”
Vinorelbine, a semi-synthetic vinca alkaloid, is a microtubule inhibitor that has been approved for use as a single agent or in combination with cisplatin for the first-line treatment of advanced non-small cell lung cancer. Vinorelbine is also widely used for the treatment of breast cancer.
Sphingosomal encapsulation is a targeted liposomal drug delivery platform, which is designed to significantly increase tumor targeting and duration of exposure for cell cycle-specific anticancer agents. Encapsulation also allows an increase in dose intensity without increased toxicity, in preclinical studies.