STOCKHOLM – October 23, 2015. Aprea AB, a Karolinska Development AB (Nasdaq Stockholm: KDEV) portfolio company, announces updated preliminary data from its ongoing Phase Ib/II clinical study in collaboration with The European Network for Translational Research in Ovarian Cancer (EUTROC). The data will be presented on Saturday, October 24, at the European Society of Gynaecological Oncology (ESGO) International Meeting in Nice, France and reinforces the indicative conclusions presented from the study on April 20, 2015; that APR-246 can be combined with standard of care chemotherapy and that preliminary efficacy data of the combination regimen show activity in treatment of recurrent ovarian cancer.
Aprea’s Phase Ib/II PiSARRO trial investigates the safety and efficacy of APR-246 in combination with carboplatin and doxorubicin in second-line treatment of patients with high grade serous ovarian cancer. Today, preliminary results for the first 24 patients in the Phase Ib part of the study are announced of which 8 patients have completed all 6 cycles of combination therapy with APR-246.
At cut-off, all patients treated in the study have stable disease or better according to RECIST criteria. In addition, 13 out of 14 evaluable patients have GCIG CA-125 (tumor antigen biomarker) response after 3 treatment cycles. Hence the preliminary efficacy data indicate that APR-246 in combination with chemotherapy has activity in patients with partially platinum sensitive as well as patients with platinum sensitive disease.
APR-246 showed linear pharmacokinetics with no accumulation and low intra patient variability and no indication of interaction between APR-246 and chemotherapy was seen. This indicates that APR-246 can be combined with carboplatin and doxorubicin at relevant doses. No new safety concerns have emerged in the study. The main treatment-emergent adverse events have been low grade gastrointestinal and central nervous system related events. One dose limiting toxicity (DLT) of ruptured diverticulum occurred at the second dose level leading to expansion of this cohort to 6 patients. A possible increase in hematological side effects over those expected with the chemotherapy alone cannot be ruled out at this stage.
Mikael von Euler, CMO of Aprea comments: “We continue to be encouraged by the preliminary results emerging from the Phase Ib part of the study. Firstly, the safety and pharmacokinetic data indicate that APR-246 can be combined with chemotherapy at full dose in the ovarian cancer setting. Secondly, the early efficacy data from the evaluable patients indicate that the combination regimen with APR-246 has activity in ovarian cancer patients that are either partially or platinum sensitive. While we are careful not to draw definite conclusions from these preliminary results, we are encouraged by the data indicating that APR-246 has the potential to improve treatment for ovarian cancer patients.”
The poster Preliminary Results from EUTROC PiSARRO: a Phase Ib Study Combining APR-246 with Standard Chemotherapy in Platinum Sensitive Relapsed High Grade Serous Ovarian Carcinoma (HGSOC) will be presented at the ESGO on Saturday, October 24, in an e-poster session that will start at 07.00 CEST and the poster is also attached to this press release and available at Aprea’s website www.aprea.com
For further information, please contact:
Ulf Björklund, CEO, Aprea AB
Phone: +46 (0) 8 508 845 04, e-mail: ulf.bjorklund@aprea.com
Jim Van heusden, CEO, Karolinska Development AB
Phone: +46 (0) 72 858 32 09, e-mail: jim.van.heusden@karolinskadevelopment.com
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