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Dosing Initiated in Phase I/II Clinical Trial of APR-246 in Ovarian Cancer

Published: Thursday, April 17, 2014
Last Updated: Thursday, April 17, 2014
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Promising data from trial has been presented in Journal of Clinical Oncology.

Aprea AB has announced that dosing has begun in the Phase I/II proof-of-concept clinical trial of APR-246 in combination with chemotherapy in patients with relapsed platinum sensitive high grade serous ovarian cancer. Aprea is a Karolinska Development AB portfolio company.

Cancers develop and spread due to the malfunction of the cells’ normal growth control mechanisms. One of the best-known cancer genes is p53 that can trigger the cellular suicide program to eliminate cancer cells. In about half of all tumors, p53 is mutated and no longer functions normally. This allows cancer cell survival and rapid tumor growth.

Aprea has successfully developed substances that can restore normal function to the p53 protein and thereby induce efficient cancer cell death and overcome resistance to antitumoral therapy. To the company’s knowledge, APR-246 is the only compound with this mechanism of action in clinical development.

"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", said John A Green, Principal Investigator of the clinical trial.

"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", said Ulf Björklund, CEO at Aprea.

APR-246 has previously been tested in a clinical Phase I/II trial in 32 patients with refractory hematological malignancies or prostate carcinoma.

“We are excited about this trial and will follow it with great interest. About 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”, said Torbjörn Bjerke, CEO of Karolinska Development.

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