The Phase 1 study investigates the efficacy of OsteoDex in patients with progressive multiple myeloma (MM). Progressive disease means that the disease progresses and does not respond to existing treatment. A patient who has shown a sharp reduction in skeletal biomarkers and who has now completed his treatment is found to have stable disease with continued low values of markers that reflect skeletal activity. Stable disease means that the disease does not develop\/progress, which is very positive. The company now intends to follow patients with stable disease for up to 2 years after completion of OsteoDex treatment. A so-called amendment has been submitted to the relevant authorities. The follow-up provides the Company with valuable information about how long OsteoDex’s effect lasts.<\/p>\n
The study covers a total of max. 20 patients and is being conducted at Karolinska University Hospital Huddinge and Uddevalla Hospital. More hospitals may be involved at a later date. The treatment lasts for a total of 14 weeks with 2 doses per month. Three dose levels are being studied. The Principal Investigator (PI) is Dr Katarina Uttervall, MD, PhD, Department of Hematology\/HERM, Karolinska University Hospital Huddinge. Analysis of biomarkers takes place at the Central Laboratory, Karolinska University Hospital Solna, NKS. Inclusion criteria include adult MM patients with
\nrelapsed (progressive) refractory disease, who received 1-5 prior lines of therapy. The primary objective is to confirm safety and tolerability and with the secondary objective to determine treatment response. The recruitment of patients is relatively slow (competing studies, inclusion requirements), which means that the conclusion of the study is postponed somewhat to Q2, 2025. This means that study costs are also postponed, which means that the Company is financed throughout 2025.<\/p>\n
“- Achieving stable disease is a very positive signal. Amendment adds great value to our study and will affect the interest in OsteoDex in this context as well as how further studies should be designed,” says CEO Anders R Holmberg.<\/p>\n