Osteros Biomedica announce initiation of a phase i clinical trial


Osteros Biomedica announce initiation of a phase i clinical trial

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.

About Maxwell Biotech

Group Maxwell Biotech Group (MBG) and Maxwell Biotech Venture Fund, formed with the participation of Russian Venture Company, provide investment capital and access to an established infrastructure for conducting high-quality clinical trials in Russia, and help enable the rapid and cost-effective achievement of clinical objectives. MBG relies on an experienced international team of managers and financial and industry experts and has offices in Moscow and Boston.

About Osteros Biomedica

Osteros Biomedica, Ltd is a private Russian biotech company founded in 2012, and part of the biotech holding company, Maxwell Biotech Group. The Company’s main goal is to develop and commercialize innovative drugs for the treatment of cancer-induced bone disease. The company has the global rights to its first product, MBC-11.

About RVC

RVC is a government fund of funds and a development institute of the Russian Federation, one of Russia's key tools in building its own national innovation system. RVC’s authorized capital is more than 30 billion rubles (about US$ 762 mln.) - 100% owned by the Russian Federation represented by the Federal Agency for State Property Management of the Russian Federation (Rosimuschestvo). All in all, RVC has backed 15 funds (including 2 funds in under a foreign jurisdiction) to a total capitalization of 27.67 billion rubles, RVC share amounting to 15.7 billion rubles. As on 2014, RVC backed funds run a portfolio of 161 companies, invested capital totaling more than 14,5 billion rubles.

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