Sweden-based Aprea, a Karolinska Development portfolio company, has started dosing patients in the Phase I/II clinical trial of APR-246 in combination with chemotherapy to treat ovarian cancer.
The trial is designed to assess the safety, efficacy, pharmacokinetics and pharmacodynamics of APR-246 in combination with carboplatin (AUC 5) and pegylated doxorubicin (30mg/m2), a second line standard of care chemotherapy for relapsed platinum sensitive high grade serous ovarian cancer.
Around 180 patients are expected to be enrolled in the two-part Phase I/II proof-of-concept trial.
Part A is an open-label, multiple ascending dose trial and its primary objectives are to evaluate the safety and tolerability of APR-246 in combination with carboplatin and pegylated doxorubicin, and confirm the dose of APR-246.
Following completion of the Part A of the trial, the company expects to start Part B, which will investigate the safety and antitumour activity of APR-246 administered in combination with carboplatin and pegylated doxorubicin, compared with carboplatin and pegylated doxorubicin alone.
The primary end-point of randomised, controlled part B will be Progression Free Survival (PFS).
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Phase I/II clinical trial principal investigator John Green said ovarian cancer has a poor prognosis, as the disease is often fairly advanced by the time these patients experience their first symptoms.
"Present therapies for recurrent ovarian cancer have little impact on survival, and we are eager to evaluate whether APR-246 can extend the efficacy of second line therapy," Green said.
Generally, cancers develop and spread due to the malfunction of the cells’ normal growth control mechanisms and one of the best-known cancer genes is p53 that can trigger the cellular suicide programme to reduce cancer cells.
Aprea CEO Ulf Björklund said the synergistic effects of APR-246 and carboplatin have resulted in very potent antitumor activity in preclinical models.
"We now look forward to evaluate the compound’s safety profile and clinical activity in combination treatment of ovarian cancer patients," Björklund said.
The company said that APR-246 has already been tested in a Phase I/II clinical trial in 32 patients with refractory haematological malignancies or prostate carcinoma.
Karolinska Development CEO Torbjörn Bjerke said around 60% of all ovarian cancer patients have mutated p53 and ovarian cancer patients with p53 mutations are less responsive to platinum than patients with wild type p53.
"Thus, it is an indication where Aprea’s APR-246 could make a difference for these patients with a great need for better treatment," Bjerke said.
Image: Micrograph of a low malignant potential mucinous ovarian tumour. Photo: courtesy of Nephron.