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Beskrivning
| Land | Sverige |
|---|---|
| Lista | Spotlight |
| Sektor | Hälsovård |
| Industri | Bioteknik |
The Phase 1 study examines the effect of OsteoDex on patients with progressive multiple myeloma (MM). Progressive disease means that the disease progresses and does not respond to existing treatment. The first dose group (3mg/kg) is now ready, and the DMC (Data Monitoring Committee) has approved the start of dose group 2 (6mg/kg). DMC assesses all analysis results to decide on the next higher dose. No side effects related to OsteoDex have been noted. All patients show a decrease in skeletal biomarkers. Three out of four patients have stable disease after completion of treatment (stable = no progression of the disease). Patients with stable disease will be followed up until new progress according to the approved amendment, which provides information on how long the treatment effect lasts.
The study includes up to a maximum of 20 patients and is being conducted at Karolinska University Hospital Huddinge and Uddevalla Hospital. More hospitals may be involved later. 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 relapsed (progressive) treatment-resistant disease, who received 1-5 prior lines of therapy. The primary objective is to confirm safety and tolerability and with a secondary objective to determine treatment response. The study is expected to be completed in Q2, 2025.
"- Stable disease in three out of four patients, with treatment-resistant disease, after completion of OsteoDex treatment with the lowest dose, is a far better result than one dared to hope. The follow-up adds great value to the study and provides important information on how further studies should be designed," says CEO Anders R Holmberg.
For more information about DexTech, please contact:
Gösta Lundgren - CFO
DexTech Medical AB
Phone: +46 (0) 707104788
E-mail: gosta.lundgren@dextechmedical.com
This information is information that DexTech Medical AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, on August 12, 2024.
DexTech Medical AB is a Swedish research company that, based on its technology platform, has developed four drug candidates that are protected by patents. The lead candidate is OsteoDex for the treatment of castration-resistant prostate cancer (CRPC) with bone metastases. A successful clinical phase II study has been conducted with OsteoDex where the results show high tolerability with mild side effects and treatment effect on patients who fail existing drugs. DexTech's goal is to out-license each drug candidate no later than after completion of the phase II study. DexTech Medical AB is listed on the Spotlight Stock Market.