Sapu BioScience and Cromos Pharma initiating P201 – A Registrational trial for OT-101 in Pancreatic Cancer

AGOURA HILLS, Calif., Aug. 23, 2023 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc (OTCQB:OTLC) ("Oncotelic", the "Company" or "We" or “Our”), announced today its joint venture partner, GMP Biotechnology Limited’s wholly owned subsidiary – Sapu Bioscience, LLC (“Sapu”), together with with Cromos Pharma, LLC (“Cromos”), a US-based international contract research organization (“CRO”), to conduct Sapu’s registrational trial for OT-101 in Pancreatic Cancer.

P201: A Randomized Phase 2b/Phase 3 Study of the TGF-β2 Targeting Antisense Oligonucleotide OT-101 in Combination with FOLFIRINOX Compared with FOLFIRINOX Alone in Patients with Advanced and Unresectable or Metastatic Pancreatic Cancer.

The rates of pancreatic cancer are rising—and are rising faster among younger women, particularly Black women, than among men of the same age. Pancreatic cancer has the highest mortality rate of all major cancers, accounting for 3% of all cancer deaths in the U.S., and is more common among men than women. Addressing this urgent medical need, Oncotelic, through Sapu, is launching a registrational Phase 2b/Phase 3 trial with their TGF-β2 targeting therapy, OT-101 in combination with Standard of Care- (FOLFIRINOX) against pancreatic cancer. This is a multinational trial with sites across the USA, EU, and China involving up to 500 patients. Sapu has engaged Cromos Pharma, an international midsized CRO, to assist in the conduct of the trial. Leveraging Cromos Pharma's distinguished oncological expertise, this collaboration underscores the joint commitment to bring innovative treatments to cancer patients.

Cromos Pharma's renowned proficiency in site selection, and its vast global network for patient enrollment, stands as an invaluable asset for this clinical trial venture. Handling complex trials with precision, Cromos Pharma's unparalleled expertise should ensure efficient, high-quality site choices and good global patient onboarding. For a trial of such magnitude and intricacy, Cromos Pharma's involvement is pivotal and will ensure streamlined operations and meticulous execution that can potentially hasten the time towards finding a solution for this devastating cancer.