Invitation to Participate in STOP-PC Clinical Trial

AGOURA HILLS, Calif., March 04, 2024 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc (OTCQB:OTLC) invites participation in our STOP-PC clinical trial which is now open for recruitment. Additional information can be obtained at www.stop-pc.com. An explainer video is available at https://www.youtube.com/watch?v=C4ZsE3fulIU.

STOP-PC is a Randomized Phase 2b/Phase 3 Study of the TGF-β2 Targeting Antisense Oligonucleotide OT-101 in Combination with mFOLFIRINOX Compared with mFOLFIRINOX Alone in Patients with Advanced and Unresectable or Metastatic Pancreatic Cancer.

The transforming growth factor-β (TGF-β for short) is a protein that modulates the activity of immune cells. In cancer tissue it suppresses immune cell response and contributes to tumor growth and spread.

OT-101 is a first-in-class RNA therapeutic designed to fight the immunosuppressive actions of TGF-β2, reduce the level of TGF-β2 in malignant tumors, and thereby delay the progression of disease.

OT-101 has demonstrated notable single-agent activity, consistently surpassing reported literature data for overall survival. Importantly, the overall survival increased in a dose-dependent manner at the levels of 140mg/m2 and higher.

The Phase 2/3 trial that you are being asked to participate in will compare OT-101 plus mFOLFORINOX with mFOLFORINOX alone as second line therapy in patients whose cancer progressed.

"STOP-PC trial is the combination of mFOLFIRINOX and OT-101 based on our demonstration that reduced TGF- β2 resulted in outstanding improvement in survival among patients treated with Irinotecan with survival beyond 34 months for the low TGF-β2 expression cohort. The mFOLFIRINOX was chosen as the most well tolerated combination of choice through discussion with regulatory authorities and key opinion leaders. We believe this trial will deliver the decisive win against pancreatic cancer," expressed Dr. Vuong Trieu, CEO of Oncotelic.

About Cromos

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. Over its almost 20-year journey, Cromos Pharma has successfully completed more than 300 clinical trials, demonstrating its commitment to excellence and precision. Its mission is to expedite the development of drugs and devices that save lives and enhance its quality. Cromos Pharma achieves this by combining innovation with validated best practices, reducing drug development time and costs while maintaining unparalleled quality standards. Cromos Pharma serves a diverse clientele, including Global Pharma, Biotechs, and other notable CROs. It has a strong operational presence across the US, Central and Eastern Europe, and Central and Southwestern Asia. Their country-specific operations cover Bulgaria, Croatia, Czech Republic, Estonia, Georgia, Hungary, Kazakhstan, Latvia, Lithuania, Moldova, Poland, Romania, Serbia, Slovak Republic, Slovenia, Türkiye, and Ukraine. For collaborations or inquiries, please contact them at [e-mail].