Aprea's unique p53 cancer treatment featured in BioWorld Today article
February 26, 2015. The newly published article in BioWorld Today covers the origin of Aprea's program aiming to reactivate non-functional tumor suppressor protein p53, the clinical data generated on the candidate drug APR-246, the treatment potential of APR-246 in ovarian cancer where a Phase I/II study is currently ongoing, and its potential use in other types of cancers.
About Aprea AB
Aprea AB is a Swedish biotech company focusing on discovery and development of novel anticancer compounds targeting the tumor suppressor protein p53. The main owner of Aprea is KDev Investments AB, part of Karolinska Development AB (publ). The other main owners are Östersjöstiftelsen, Praktikerinvest and KCIF Co-Investment Fund KB. For more information, please visit www.aprea.com
APR-246 has been developed based on results from researchers at Karolinska Institutet, and has been shown to reactivate non-functional tumor suppressor protein p53 and induce programmed cell death in many human cancer cells. Preclinical studies have confirmed that APR-246 can activate mutated p53 and demonstrated single agent efficacy and very strong synergy with conventional anti-cancer agents in vitro and in vivo. A clinical Phase Ib/II study in hematological malignancies and prostate cancer has been completed, demonstrating a favorable safety profile and both biological and clinical responses. A Phase Ib/II proof-of-concept study in ovarian cancer patients carrying mutant p53 is currently ongoing.
About the PiSARRO trial
The Phase Ib/II trial is designed to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of APR-246 in combination with carboplatin (AUC 5) and pegylated doxorubicin (30 mg/m2), a second line standard of care chemotherapy for relapsed platinum sensitive high grade serous ovarian cancer. The Phase Ib/II trial is a two-part study that will enroll approximately 180 patients. Part A is an open-label, multiple ascending dose study. The primary objectives of Phase Ib are to evaluate the safety and tolerability of APR-246 in combination with carboplatin and pegylated doxorubicin, and to confirm the dose of APR-246. Pending successful completion of this phase, Aprea expects to initiate Part B of the trial, which will be a randomized, controlled study investigating the safety and antitumor activity of APR-246 administered in combination with carboplatin and pegylated doxorubicin, compared with carboplatin and pegylated doxorubicin alone. Primary end point of Phase II will be Progression Free Survival (PFS). For details on the PiSARRO trial please visit: www.ClinicalTrials.gov.