Karolinska Development announces that its portfolio company Aprea Therapeutics has enrolled the first patients in the Phase II part of the ongoing PiSARRO clinical study of APR-246 for the treatment of high-grade serous ovarian cancer.
“The initiation of the Phase II clinical study marks an important milestone for Aprea,” said Christian S. Schade, President and Chief Executive Officer of Aprea Therapeutics AB. “We are committed to developing and advancing therapies targeting p53 and, together with upcoming clinical studies of APR-246 in other tumor types, this Phase II study in ovarian cancer affirms the progress Aprea is making toward the development of next-generation anticancer treatments.”
In the Phase II clinical study, Aprea will enroll up to 400 relapsed, p53-mutated high-grade serous ovarian cancer patients in Europe and the United States. Patients will be randomized between carboplatin and pegylated liposomal doxorubicin with or without APR-246; the primary endpoint for the study is progression-free survival. This study follows successful completion of Phase Ib clinical studies showing that APR-246 is generally well-tolerated while showing robust signals of efficacy in patients with serious disease.
Dr. Mikael von Euler, Aprea’s Senior Vice President and Chief Medical Officer added, “APR-246 is an exciting new agent because it targets tumors with mutant forms of p53, the gene most frequently altered in human cancers. The Phase Ib portion of this study demonstrated not only that APR-246 can be safely combined with standard chemotherapy for relapsed ovarian cancer but also that a favorable impact on progression-free survival could be achieved with the combination regimen in this difficult-to-treat population. We are pleased to continue development of this drug candidate and look forward to validating these Phase Ib findings in the randomized Phase II part of the study.”