The manufacturer announced that it is starting clinical trials of BCD-248, an original drug for the treatment of multiple myeloma. The trial will take place in specialized centers in Moscow and St. Petersburg.
During the first phase of the trial, it is planned to evaluate the safety, efficacy, and immunogenicity of the drug as monotherapy for patients with relapsed or refractory multiple myeloma. In addition, the trial will determine the optimal dosage regimen of the drug for the second phase of the trials.
To participate in the trial, patients have to be over the age of 18 and have a confirmed diagnosis of multiple myeloma in accordance with the criteria of IMWG (International Myeloma Working Group). The trial will involve aspiration biopsy of the bone marrow.
“BCD-248 has already been studied in a number of physico-chemical studies and preclinical trials. Our new development is an innovative drug, which is a bispecific monoclonal antibody. A number of mutations were used in the drug molecule to improve its pharmacokinetic parameters and reduce the risk of severe adverse events,” the report says.