30/08/2024 | Press release | Distributed by Public on 30/08/2024 10:32
Reports
Publicerat: 2024-08-30 12:30:00
Summary of year-end report
Fourth quarter (2024-04-01 - 2024-06-30)
Full year (2023-07-01 - 2024-06-30)
* Before and after dilution. Earnings per share: Profit for the period divided by the average number of shares 18,485,857. For the comparison period, the average number of shares was 18,485,857. Amounts in brackets refer to the corresponding period last year.
Comments from the CEO
On August 12, DexTech Medical announced new positive results from the myeloma study. The Phase 1 study examines the efficacy of OsteoDex in patients with progressive treatment-resistant 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 principal investigator (PI) is Dr Katarina Uttervall, MD, PhD, Department of Hematology/HERM, Karolinska University Hospital, Huddinge. Biomarkers are analysed at the Central Laboratory, Karolinska University Hospital, NKS, Solna. Patients with relapsed/treatment-resistant disease who have received 1-5 prior lines of therapy are included. The primary objective is to confirm safety and tolerability and as a secondary objective to determine any treatment response. Documentation of quality of life will also be done (QoL scores).
The first patient was treated in December at Karolinska University Hospital in Huddinge. The first test results from patient 1 were received on 23 January and show a very strong effect on the marker of osteoclasts activity (CTX). The patient has now completed treatment according to the study protocol and now has stable disease. Stable disease means that the disease does not progress (slowed down). The results are important and indicate that Osteodex can slow relapsed/treatment-resistant disease.
The fact that three out of four patients respond to treatment with the lowest dose exceeds all expectations. We look forward with excitement to treatment with higher doses.
Anders R Holmberg
Contact
Anders Holmberg, CEO, +46 73 324 27 82
Gösta Lundgren, CFO, +46 70 710 47 88
This information is such information that DexTech Medical AB is required to disclose in accordance with the EU Market Abuse Regulation. The information was submitted for publication on August 30, 2024 through the care of the above contact persons.
DexTech Medical ABis a Swedish research company that, based on its technology platform, has developed four drug candidates that are protected by patents. The main 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 on 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 Spotlight Stock Market.