Oncotelic Therapeutics, Inc. ("Oncotelic" or the "Company") (OTCQB:OTLC), a leading developer of TGF-β therapeutics for oncology and virology, today announced that its COVID-19 trial (“C001”) for OT-101 has successfully met its safety and efficacy endpoints.
OT-101 is a first-in-class anti-TGF-β ribonucleic acid (“RNA”) therapeutic that has exhibited single agent activity in relapsed/refractory cancer patients in multiple clinical trials. OT-101 has also demonstrated activity against the SARS-CoV-2 virus, the virus that causes COVID-19, and is currently being evaluated in the Company’s C001 clinical trial against hospitalized severe COVID-19 patients.
Both tumor cells and SARS-Cov-2 induce TGF-β as part of their immune evasion mechanism. Consequently, inhibiting TGF-β by OT-101 is expected to impact both cancer and COVID. By targeting the host protein, OT-101 is expected to work against multiple respiratory viruses, including related emerging variants, unlike traditional antiviral drugs and vaccines.
On October 18, Data lock and Study Data and Analysis Data Models (SDTMs & ADaMS Databases) were generated for a Phase 2 C001 Covid Study: “A Double-Blind, Randomized, Placebo Controlled, Multi-Center Study of OT-101 in Hospitalized COVID-19 Subjects”. The trial compares OT-101 + Standard of Care (“SOC”) versus Placebo + SOC (N= 32 patients, at 2:1 randomization ratio). SOC includes dexamethasone, the only drug known to improve outcomes in severe cases of COVID-19. The top line data is:
- Safety endpoints met. OT-101 as a TGF-β inhibitor was safe to administer to COVID-19 patients including severe/critical COVID-19 patients.
- Efficacy signals were obtained. End of treatment (Day 7) mortality for the entire study population was 4.5% OT-101 versus 20% for placebo.
- Incidence of >96% viral load knockdown on End of Treatment (Day 7) was 89% for OT-101 versus 67% for placebo.
- Overall survival improved 3X for critical COVID-19 patients (4 days for placebo versus 14 days for OT-101, p < 0.0166).
“It is gratifying that the TGF-β concept that we put forward has now been validated,” said Dr. Vuong Trieu, CEO and Chairman of Oncotelic. “The data form the basis for further development of OT-101 as a viable treatment for severe respiratory viral infections, including flu and COVID-19. We thank the patients and investigators involved, especially Dr. Carbajal of Calle Mariscal Sucre, Chancay, Huaral, Lima, Peru, who drove the study to its conclusion.”
“The resulting data clearly suggest a favorable clinical response to OT-101 in the treatment of patients with COVID-19,” noted Dr. Anthony Maida, Chief Clinical Officer – Translational Medicine. “Additionally, we were able to demonstrate that there is no evidence of delivering OT-101 and any effect relating to cytokine release syndrome.”
Oncotelic Therapeutics, Inc. ("Oncotelic" or the "Company") (OTCQB:OTLC), a leading developer of TGF-beta therapeutics for oncology and virology.
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About Oncotelic Therapeutics
Oncotelic Therapeutics, Inc. (f/k/a Mateon Therapeutics, Inc.) ("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.
Oncotelic is an artificial intelligence driven immuno-oncology company with a robust pipeline of first in class TGF-beta immunotherapies for late stage cancers such as gliomas, pancreatic cancer and melanoma. OT-101, the lead immuno-oncology drug candidate of Oncotelic, is a first-in-class anti-TGF-beta RNA therapeutic that exhibited single agent activity in relapsed/refractory cancer patients. OT-101 also has shown activity against SARS-CoV-2 and has completed a phase 2 trial against COVID-19 with data cleaning and datalock ongoing. Oncotelic is seeking to leverage its deep expertise in oncology drug development to improve treatment outcomes and survival of cancer patients with a special emphasis on rare pediatric cancers. Oncotelic also has rare pediatric designation for DIPG (OT-101), melanoma (CA4P), and AML (OXi 4503). The Company also acquired PointR Data Inc. ("PointR") in November 2019.
Oncotelic Therapeutics Inc