Aankondiging • Jun 04
DexTech Medical AB Reports Positive Preliminary Results From Fully Recruited Myeloma Study With OsteoDex DexTech Medical AB conducted a study at Karolinska University Hospital Huddinge and at Uddevalla Hospital. The treatment has lasted for a total of 14 weeks with 2 doses per month. Three dose levels of OsteoDex (ODX) have been studied, 3mg/kg body weight, 6mg/kg, and 9mg/kg. Analysis of biomarkers takes place at the Central Laboratory, Karolinska University Hospital Solna, NKS. Adult myeloma patients with, according to IMWG (International Myeloma Working Group) criteria, progressive treatment-resistant disease, who had previously received 1-5 lines of treatment were included in the study. The primary objective is to confirm ODX safety and tolerability and with a secondary objective to demonstrate indications of treatment response. The last patient in dose group 2 (6mg/kg) was fully treated week 50, 2025 (7 doses). The patient continued to have stable, i.e. non-progressive, disease just over 5 months after the end of treatment and before new progress resumed. All patients in dose group 3 (9mg/kg) had achieved stable (non-progressive) disease after discontinuation of treatment at the end of February. The patients have continued to maintain non-progressive disease at the end of May. No significant ODX-related adverse events have been noted. Thus, no induced toxicity on organ systems, such as kidneys, liver, or bone marrow. Primary endpoint has been met, with the absence of significant ODX-related toxicity. The results also show that all patients responded positively to ODX treatment, with a transition from progressive (according to IMWG criteria) to non-progressive disease during ODX treatment. More than 70% of the patients maintained their achieved stable, non-progressive, disease even after the ODX treatment was discontinued. This is consistent with the mechanism of action, i.e. significant enrichment of ODX in the myeloma areas of the skeleton. The patients in dose group 3 are now being followed continuously (>June) until new disease progression, which is why the completion of the CSR (clinical study report) is postponed until all results from the extended follow-up are available. The company has analyzed all clinical data, including the prostate cancer studies (mCRPC), and finds the effects of the same mode of action (MOA) in both mCRPC and multiple myeloma. Simply described, ODX rapidly changes/modifies the tumor cells' microenvironment and thereby impairs their breeding ground and the conditions for continued growth (progression). The mechanism is unique to ODX as an anticancer drug and has very interesting implications for the treatment of other cancers with bone involvement, e.g. breast cancer. The absence of ODX-related toxicity opens up great opportunities for combination therapies (very common in modern cancer treatment) without adding toxicity. Aankondiging • Jan 27
DexTech Medical Ab's Myeloma Study, Completes At the End of February 2026, Concludes with Continued Strong Results DexTech Medical AB (publ) announced that the study is being conducted at Karolinska University Hospital Huddinge and at Uddevalla Hospital. The treatment lasts for a total of 14 weeks with 2 doses per month. Three dose levels of OsteoDex (ODX) are studied, 3mg/kg body weight, 6mg/kg, and 9mg/kg. The Principal Investigator (PI) is Dr Katarina Uttervall, MD, PhD, Department of Hematology/HERM, Karolinska University HospitalHuddinge. Dr Dorota Knut is the principal investigator at the Department of Hematology at Udevalla Hospital. Analysis of biomarkers takes place at the Central Laboratory, Karolinska University hospital Solna, NKS. Adult myeloma patients with progressive treatment-resistant disease, who have previously received 1-5 prior lines of therapy, are included in the study. The primary objective is to confirm ODX safety and tolerability and with a secondary objective to demonstrate indications of treatment response. The last patient in dose group 2 (6mg/kg) was finished in week 50 (7 doses) and has had his last visit. The patient then continued to have stable disease. All patients in dose group 3 (9mg/kg) have achieved stable disease and will be completed by the end of February. No significant ODX related side effects have been noted. Patients with stable disease after completion of ODX treatment are followed until new progress to map how long the disease-inhibiting effect persists. Data obtained so far show that the disease-inhibiting effects in some cases persists for months and at most up to six months without initiation of other cancer treatment. The results show that all patients responded positively to the ODX treatment, with a transition from progressive disease to stable disease. Aankondiging • Dec 05
DexTech Medical's Myeloma Study (ODX-MM-001), Dose Group 2 and Dose Group 3 DexTech Medical AB (publ) announced that the study is being conducted at Karolinska University Hospital Huddinge and at Uddevalla Hospital. The treatment lasts for a total of 14 weeks with 2 doses per month. Three dose levels of ODX are studied, 3mg/kg body weight, 6mg/kg, and 9mg/kg. The Principal Investigator (PI) is Dr Katarina Uttervall, MD, PhD, Department of Hematology/HERM, Karolinska University HospitalHuddinge. Dr Dorota Knut is the principal investigator at the Department of Hematology at Udevalla Hospital. Analysis of biomarkers takes place at the Central Laboratory, Karolinska University hospital Solna, NKS. Adult myeloma patients with progressive, treatment-resistant, disease, who have previously received 1-5 prior lines of treatment are included in the study. The primary objective is to confirm ODX safety and tolerability and with a secondary objective to demonstrate indications of treatment response. The last patient in dose group 2 (6mg/kg) is expected to be finished at week 50 (7 doses). After 6 doses, the patient has still maintained their achieved stable disease, i.e. the progression verified prior to the start of treatment has stopped. The other 3 patients in dose group 2 have, after completion of ODX treatment and the disease was stable, now returned to their progressive disease. The first patient in dose group 3 (9mg/kg) has received 3 doses to date. Here, too, the progressive disease has turned into a stable one. A further 2 patients in dose group 3 have only recently started their ODX treatment. This means that so far, 9/9 (100%) of patients have responded positively to ODX treatment (transition from progressive disease to stable disease). The patients are followed as planned after completion of ODX treatment; this is to map when the disease progresses again. The disease-inhibiting effect persists in some cases even after postponed ODX treatment, at most up to six months. Aankondiging • Oct 17
DexTech Medical's Myeloma Study, Dose Group 2, DMC Gives OK for Dose Group 3 DexTech Medical AB (publ) announced that the study is being conducted at Karolinska University Hospital Huddinge and at Uddevalla Hospital. The treatment lasts for a total of 14 weeks with 2 doses per month. Three dose levels of ODX are studied, 3mg/kg body weight, 6mg/kg, and 9mg/kg. The Principal Investigator (PI) is Dr Katarina Uttervall, MD, PhD, Department of Hematology/HERM, Karolinska University HospitalHuddinge. Dr Dorota Knut is the principal investigator at the Department of Hematology at Udevalla Hospital. Analysis of biomarkers takes place at the Central Laboratory, Karolinska University hospital Solna, NKS. Adult myeloma patients with progressive treatment-resistant disease, who have previously received 1-5 prior lines of therapy, are included in the study. The primary objective is to confirm ODX safety and tolerability and with a secondary objective to demonstrate indications of treatment response. Dose group 2 (6mg/kg) has been fully recruited. Two patients in dose group 2 have progressive disease after completion of treatment. The other 2 patients will finish the treatment in early December. The DMC (Independent Data Monitoring Committee) approves the continuation to dose group 3. No ODX related serious side effects have been noted. A new patient for dose group 3 has been screened. Follow-up of all patients who have achieved stable disease is done to determine how long the disease-slowing effect persists after the ODX treatment has been discontinued, i.e., until new progress. Aankondiging • Aug 21
DexTech Medical AB Announces Study of ODX Treatment for Adult Myeloma Patients with Progressive Treatment-Resistant Disease DexTech Medical AB announced that the study is being conducted at Karolinska University Hospital Huddinge and at Uddevalla Hospital. The treatment lasts for a total of 14 weeks with 2 doses per month. Three dose levels of ODX are studied, 3mg/kg body weight, 6mg/kg, and 9mg/kg. The Principal Investigator (PI) is Dr Katarina Uttervall, MD, PhD, Department of Hematology/HERM, Karolinska University hospital Huddinge. Dr Dorota Knut is the principal investigator at the Department of Hematology at Uddevalla Hospital". Analysis of biomarkers takes place at the Central Laboratory, Karolinska University Hospital Solna, NKS. Adult myeloma patients with progressive treatment-resistant disease, who have previously received 1-5 prior lines of therapy, are included in the study. The primary objective is to confirm ODX safety and tolerability and with a secondary objective to demonstrate indications of treatment response. Dose group 2 (6mg/kg) is expected to be fully recruited in August/September. Two patients in dose group 2 have progressive disease after completion of treatment. This means that so far, 67% of patients have responded positively to ODX treatment (transition from progressive disease to stable disease). No significant, ODX-related, side effects have been noted. Follow-up of all patients who have achieved stable disease is done to determine how long the disease-inhibiting effect persists after the ODX treatment has been discontinued. Follow-up of patients from dose group 1 shows that the disease-inhibiting impact continued, even after discontinuation of ODX. At most, the disease-inhibiting effects lasted just over six months without the initiation of other cancer treatment. A meeting of the DMC (the independent data monitoring committee) is expected to be held in September to approve the continuation to dose group 3. Aankondiging • May 21
Dextech Medical's Patent Application Regarding Gmp Manufacturing of Osteodex is approved OsteoDex is DexTech's lead candidate for the treatment of castration-resistant prostate cancer and has completed clinical phase 2. In October 2023, the Company filed a patent application with the EPO (European patent office, application No. 23203437.1). The application concerned GMP (Good Manufacturing Practice) manufacturing of OsteoDex. The application has now been approved, and a patent has been granted. The patent is of great importance for the continued clinical development of OsteoDex and future market exclusivity. The patent is valid until 2045 and is very positive for the Company's partnership/out-licensing talks. 