The Uppsala-based company’s study included eleven adults with progressive, treatment-resistant myeloma who had previously received one to five lines of treatment. All patients went from progressive to stable disease during treatment. More than 70% of them stayed stable after treatment ended, for up to thirty weeks (mean 25.1 weeks), without receiving any other cancer treatment during follow-up.

Bone cell markers fell markedly during treatment, while myeloma markers stayed relatively unchanged. No abnormal heart, liver, or kidney values were observed.

According to DexTech, the results verify the drug’s mechanism of action. OsteoDex modifies the tumor cells’ microenvironment in the skeleton, which slows or stops further growth and stabilizes the disease. The company says the mechanism could also be used in other cancers that spread to the bone, such as late-stage breast cancer. It adds that the favorable safety profile opens up opportunities for combination treatments without adding toxicity.

The study was conducted at Karolinska University Hospital in Huddinge and Uddevalla Hospital. Patients received two doses per month for fourteen weeks, at three dose levels: 3, 6, and 9 mg/kg body weight. The primary objective was to confirm the safety and tolerability of OsteoDex, and the secondary objective was to find signs of treatment response.

“We can now confidently present strong data to our stakeholders, backed by the study results, a unique mechanism of action, and strengthened patent protection,” says Anders R. Holmberg, CEO, DexTech Medical.