The first test results from patient 1 have been received and show a very strong effect on the marker of osteoclast activity (CTX), states the company.

The baseline value for CTX decreases by about 80% after 3 doses of OsteoDex. The other values are fairly constant (cf. baseline). Osteoclasts break down bone (resorb) and CTX reflects osteoclast activity that is elevated in multiple myeloma.

“Since multiple myeloma, like bone metastases from prostate cancer (mCRPC), is stimulated by the activity of bone cells, today’s results are promising. It will be very exciting to follow the direct and secondary effect on the tumor disease,” says CEO Anders R Holmberg.

About the Phase 1 study

The Phase 1 study investigates the efficacy of OsteoDex in patients with progressive multiple myeloma (MM). The first patient is treated during week 50 at Karolinska University Hospital in Huddinge. The study includes a total of 20 patients and will initially be conducted at three hospitals in Sweden: Karolinska University Hospital Huddinge, Uddevalla Hospital and Södersjukhuset in Stockholm. The treatment lasts for a total of 14 weeks with 2 doses per month. Three dose levels are being studied. Analysis of biomarkers takes place at the Central Laboratory, Karolinska University Hospital Solna, NKS. Inclusion criteria include adult MM patients with relapsed (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 study is expected to be completed in Q4, 2024.

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