Date: 2014-10-28
Type of information: Initiation of the trial
phase: 1
Announcement: initiation of the trial
Company: Osteros Biomedica (Russia)
Product: MBC-11
Action
mechanism: 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.
Disease: cancer-induced bone disease
Therapeutic area: Cancer - Oncology - Bone diseases
Country:
Trial details:
Latest
news: * On October 28, 2014, Osteros Biomedica, a joint venture company of Maxwell Biotech Group and MBC Pharma with the participation of Russian Venture Company announced 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.
