Sapu BioScience, Cromos Pharma initiate P201, a registrational trial for OT-101 in pancreatic cancer

August 25, 2023

Oncotelic Therapeutics, Inc announced 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-ß2 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 US, 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-ß2 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.

"Over the past years we have been meticulously planning this trial to ensure its success. Spearheaded by our discovery that suppression of TGFß2 could more than double survival in pancreatic cancer, we have engineered the trial to deliver a decisive win against pancreatic cancer. We look forward to engage physicians and patients in this critically important clinical trial," expressed Dr. Vuong Trieu, CEO of Sapu and Oncotelic.

"It's truly an honour for Cromos to collaborate with Sapu and Oncotelic, visionaries within the oncology space. 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. Together, we aim to break new ground to bring a new therapy to those affected by pancreatic cancer," said Dr. Vlad Bogin, MD, FACP, CEO & founder of Cromos Pharma.

Founded in 2004 and headquartered in the United States, Cromos Pharma is an international CRO. Cromos offers comprehensive clinical research solutions, covering all trial phases and a wide range of therapeutic areas. These areas include oncology, cardiovascular diseases, and gastroenterology.
Oncotelic, was formed in the State of New York in 1988 as OXiGENE, Inc., was reincorporated in the State of Delaware in 1992, and changed its name to Mateon Therapeutics, Inc. in 2016, and Oncotelic Therapeutics, Inc. in November 2020.

PHARMABIZ.com