Aprea, a Karolinska Development portfolio company, has reported positive clinical data of its investigational drug, APR-246, from a Phase I/II study.
The study enrolled 22 patients to demonstrate the safety and efficacy of APR-246 in treating patients with advanced blood or prostate cancer, according to the company.
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Escalating doses of APR-246 were administered as monotherapy to 22 patients on up to four consecutive days during the study, which demonstrated dose-proportional and time-independent pharmacokinetics for APR-246 over the dose range studied.
The results further noted that the drug has good tolerability, and shows 50% reduction in the number of blast cells in the bone marrow, as well as dose limiting toxicity at plasma levels.
In addition to the tolerability, the study also concluded that APR-246 induces biological effects and that there are cases of clinical effects on tumor burden.
Karolinska Development CEO Torbjörn Bjerke said the data indicates that APR-246 has an anti-tumor effect.
"APR-246 was well tolerated and, importantly, the safety profile is different from traditional cytostatic drugs," Bjerke said.
"With these new results we can see a clear path forward for APR-246, especially in carboplatin-resistant patients."
Aprea CEO Ulf Björklund said; "We are now planning to take the p53-activating compound APR-246 forward into a Phase II-trial in epithelial ovarian cancer with mutated p53 in combination with conventional chemotherapy."
