Osteros begins Phase I trial of MBC-11 to treat cancer-induced bone disease

The trial is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses MBC-11, a lead compound from a technology platform based on bisphosphonate driven bone targeted delivery of chemotherapy agents.

It is a synthetic chemical conjugate of a bone-targeting vehicle (Etidronate) and an anti-cancer agent (Cytarabine).

The company said that imaging, bone turnover and tumor specific biomarkers and pain assessment will be used to evaluate tumor response and therapeutic effect.

The trial will enrol around 18 patients with established bone lesions from any cancer type.

Predisposition to skeletal metastases in cancers such breast, prostate and multiple myeloma are expected to predominate patient enrolment in the trial.

Osteros is a joint venture company of Maxwell Biotech Group and MBC Pharma.

Osteros Biomedica scientific advisor and MBC Pharma president Alexander Karpeisky said: "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 designed to target malignant bone lesions and allows higher concentrations of drug at the sites of tumor-associated bone destruction than is otherwise possible; and may reduce systemic toxicity.