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news.Aprea, a Karolinska Development portfolio company, has presented positive clinical data of its investigational drug, APR-246, from a Phase I/II study.
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The study, which has recruited 22 patients, is designed to demonstrate the safety and efficacy of APR-246 in treating patients with advanced cancers.
Escalating doses of APR-246 were given as monotherapy to 22 patients with advanced blood or prostate cancer during up to four consecutive days.
The study also demonstrated dose-proportional and time-independent pharmacokinetics for APR-246 over the dose range studied.
The results demonstrated that the drug was well tolerated, 50% reduction in the number of blast cells in the bone marrow were observed as well as dose limiting toxicity was shown at plasma levels well above predicted therapeutic 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 Torbjorn Bjerke APR-246 was well tolerated and, importantly, the safety profile is different from traditional cytostatic drugs.
"With these new results we can see a clear path forward for APR-246, especially in carboplatin-resistant patients," Bjerke added.
Aprea CEO Ulf Bjorklund 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."