DexTech's Phase IIb study for OsteoDex ends with positive follow-up results
The company's randomized Phase IIb study for the treatment of bone metastatic castration-resistant prostate cancer (mCRPC) has now been completed with 2-year follow-up results from the last patients.
The primary endpoints of the study concerning markers of bone metabolism have been well achieved. A clear majority of patients showed reduction in their skeletal markers in the blood of the given treatment with OsteoDex. Treatment was very well tolerated (few and mild side effects) and good disease-slowing effect was also seen in the lowest doses. The slowing down and decline of the disease was also seen in patients who have progressed on several of the other available medications for castration-resistant prostate cancer.
The secondary endpoints of the study include overall survival studied by 24 months of post-treatment follow-up. Of the patients who responded to treatment, with deceleration or stabilization of the disease, the median survival has not yet been achieved (> 27 months), compared with 14 months for the other patients (significance, p <0.05). Survival 2 years after baseline is 65% for patients who responded to treatment, with deceleration or stabilization of the disease, compared with 28% for other patients (significance, p <0.05).
The results of the study are very positive and show that OsteoDex effectively slows down the tumour disease. Overall survival data should be seen as an indication, as these data need, for natural reasons, be confirmed in a significantly larger, so-called Phase III study.
None of the modern medicines are curative in castration-resistant prostate cancer and there is therefore a great need (unmet need) for new potent and well tolerated drugs. OsteoDex has a clear potential to meet this need.
The company's intention is to sign a license agreement before the end of the current year.
"These are important results that are important in our business discussions," says CEO Anders R Holmberg."
For further information
Gösta Lundgren - CFO & Investor Relations
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, through the agency of the above contact person, for publication on June 12, 2020.
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 main candidate is OsteoDex for the treatment of castration-resistant prostate cancer (CRPC) with skeletal metastases. A successful Phase II clinical trial has been conducted with OsteoDex where the result shows high tolerability with mild side effects as well as treatment effect on patients who fail on existing drugs. DexTech's goal is to license the respective drug candidate by the latest phase II study. DexTech Medical AB is listed on the Spotlight Stock Market.