Date: 2011-02-23
Type of information: Completion of the trial
phase: 1-2
Announcement: completion of the trial
Company: Aprea (Sweden)
Product: APR-246
Action
mechanism: APR-246 has been developed based upon results from researcher at the Karolinska Institute. The researchers have discovered that the substance is more efficacious in cancer cells than normal cells, which indicates it could produce significantly fewer side effects than conventional cancer treatments. By inducing the protein p53 the compound makes sure that the cellular suicide program is activated to eliminate the cancer cells. This has been shown in laboratories and animal studies with good results. A unique characteristic of the substance is that it can activate p53 even when the gene is inactivated due to a mutation. Cancers with mutated p53 are often resistant to conventional treatment.
The compound has been tested in a phase I/II clinical trial at seven clinics in Sweden.
Disease: refractory hematological malignancies
prostate cancer
Therapeutic area: Cancer - Oncology
Country: Sweden
Trial
details: The open labeled, dose-escalating study included 22 patients with advanced blood or prostate cancer. The study was designed to reveal the highest feasible dose of APR-246 (primary endpoint) after 2 hours iv-infusions for up to four consecutive days in escalating doses. Dose limiting toxicity was shown at plasma levels well above predicted therapeutic plasma levels. The study also demonstrated dose and time independent pharmacokinetics of APR-246 over the dose range studied.
Latest
news: Aprea has conducted a Phase I/II dose-escalating safety study with APR-246 in patients with refractory hematological malignancies or prostate cancer. The results show that the compound is safe at predicted therapeutic plasma levels. The study was designed to reveal the highest feasible dose of APR-246 (primary endpoint) after 2 hours iv-infusions for up to four consecutive days in escalating doses. Dose limiting toxicity was shown at plasma levels well above predicted therapeutic plasma levels. The study also demonstrated dose and time independent pharmacokinetics of APR-246 over the dose range studied.
