Sapu Bioscience and Cromos Pharma are set to initiate a Phase IIb/III study evaluating the TGF-β2 targeting antisense oligonucleotide OT-101 along with FOLFIRINOX in pancreatic cancer patients.
The multinational, registrational study will compare the combined therapy against FOLFIRINOX alone in patients with advanced and unresectable or metastatic pancreatic cancer.
Nearly 500 patients will be enrolled from the sites across China, the EU and the US.
Cromos Pharma, an international mid-sized CRO, will assist Sapu in the conduct of the trial.
Cromos Pharma CEO and founder Dr Vlad Bogin said: “With over 20 years in the drug development cycle, I have witnessed firsthand the monumental impact such partnerships can have on advancing medicine.
“Our expertise will ensure that this clinical trial’s complexities are navigated with precision and efficiency.
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“Together, we aim to break new ground to bring a new therapy to those affected by pancreatic cancer.”
Pancreatic cancer is claimed to be more common among men than women accounting for 3% of all cancer deaths in the US.
Sapu Bioscience is a subsidiary of GMP Biotechnology, a joint venture partner of Oncotelic Therapeutics.
Last May, Oncotelic received approval from the FDA to commence the Phase II M201 clinical trial of OT-101 plus pembrolizumab in patients with malignant pleural mesothelioma.
Merck agreed to supply the anti-PD-1 inhibitor pembrolizumab for this investigator-initiated study.