Osteros Biomedica Ltd., a joint venture company of Maxwell Biotech Group and MBC Pharma Inc., and formed with the participation of Russian Venture Company announced today that the first cohort of patients has been dosed in a phase 1 study of its drug MBC-11 in patients with cancer-induced bone disease.
The open-label dose-escalation trial investigates safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses MBC-11. Imaging, bone turnover and tumor specific biomarkers and pain assessment will be used to evaluate tumor response and therapeutic effect. Eighteen patients with established bone lesions from any cancer type will be enrolled in the study-predisposition to skeletal metastases in cancers such breast, prostate and multiple myeloma are anticipated to predominate patient enrollment.
Alexander Karpeisky, Scientific Advisor of Osteros Biomedica, President of MBC Pharma, commented, "We are excited to see the initiation of this trial and hope the pre-clinical observations of bone targeted anti-cancer efficacy, anti-resorptive activity and a good safety profile translate to the clinic".
MBC-11 is the lead compound from a technology platform based on bisphosphonate driven bone targeted delivery of chemotherapy agents. MBC-11 is a synthetic chemical conjugate of a bone-targeting vehicle (Etidronate) and an anti-cancer agent (Cytarabine). It is designed to target malignant bone lesions and enables higher concentrations of drug at the sites of tumor-associated bone destruction than is otherwise possible; and may reduce systemic toxicity.
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