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.
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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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By GlobalData“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.
