FHI Clinical contributing to protocol design for CTO therapy in development for mild, moderate or severe COVID-19 and acute respiratory distress syndrome (ARDS)
NEW YORK, NEW YORK and DURHAM, NORTH CAROLINA – FHI Clinical Inc is contributing to the protocol design for a Phase 2 clinical trial to evaluate carboxyamidotriazole orotate (CTO), an asset from the clinical-stage company Tactical Therapeutics, Inc., to treat hospitalized patients with acute respiratory distress syndrome (ARDS). A first-in-class calcium signal inhibitor, CTO is an orally administered, small molecule that has demonstrated effectiveness against cancers with a poor prognosis, such as glioblastoma. Its unique mechanism of action also shows promise to target immune dysregulation and tissue repair in ARDS as well as directly target SARS-CoV-2.
FHI Clinical has supported 26 COVID-19 trials across 31 countries, with 11 currently in progress, and is proud to contribute to the development of new medicines to fill the armamentarium for COVID-19 and other infectious respiratory diseases such as ARDS, which does not currently have an approved pharmacological therapy.
“FHI Clinical is a leader in conducting many human trials of COVID-19 therapies and drugs for other infectious diseases like ARDS and is the best partner to assist us in designing scientifically sound clinical trials for CTO,” said Dr. Rashida Karmali, President and Chief Executive Officer of Tactical Therapeutics.
Because CTO is being developed as an antiviral acting directly against the virus, it fills the gap in current therapeutics, which primarily address the disease processes in late-stage COVID-19. Its ability to act as a broad anti-inflammatory targeting immune dysregulation and tissue repair in ARDS broadens the patient population who could potentially benefit from CTO and has the potential to address the unmet need for approved pharmacological therapies for ARDS.
“I’m honored to be working with Tactical Therapeutics to explore the full potential of this promising drug for its immune modulation of inflammatory cytokines as well as its direct antiviral effects,” commented Jon “Ben” Woods, MD, Senior Medical Advisor, FHI Clinical. “There remains a great need for easily administered, safe and shelf-stable treatments for ARDS, COVID-19 and other infections, and I am excited to be participating in this important research.”
The protocol in development is being prepared to support a randomized, double-blind, placebo-controlled, multicenter Phase 2 clinical trial of immunomodulators or other host-directed therapies for the treatment of hospitalized patients with ARDS, in response to an RFI issued by the Biomedical Advanced Research and Development Authority (BARDA)/Influenza and Emerging Infectious Diseases Division (IEIDD).
In a completed Phase 1 study, Tactical Therapeutics demonstrated that CTO inhibited many of the inflammatory cytokines found in the “cytokine storm” in cancer patients. In preclinical evaluations in Vero E6 cell cultures, CTO inhibited the replication of SARS-CoV-2.
About FHI Clinical
FHI Clinical is a full-service contract research organization (CRO) with the global expertise, responsive approaches and proven solutions to manage complex clinical research around the world. Benefitting from our 50+ year history of clinical research, our team of approximately 450 global staff has worked on studies in more than 70 countries. As problem solvers, forward thinkers and on-the-ground members of those communities, we are dedicated to helping you find solutions to the research challenges that have kept life-saving therapies from at-risk populations. Visit fhiclinical.com or contact us at info@fhiclinical.com or 919.321.3321 to learn how we can put our diverse clinical and operational expertise to work for you.
About carboxyamidotriazole orotate (CTO) and intellectual property (IP)
CTO is a patented first-in-class inhibitor of genes of non-voltage dependent calcium signaling associated with multiple oncolytic pathways and calcium channels. In a Phase 1 clinical trial evaluating CTO monotherapy, CTO inhibited the production of several cytokines including VEGF, GM-CSF, INF-ɤ, IL-2, IL-2, IL-6, IL-8, MIP1-alpha, IL-1β and TNF-alpha. In preclinical studies, CTO inhibited the replication of SARS-CoV-2 in Vero-E6 cells in vitro.
The company’s IP portfolio includes 8 US and 75 international patents lasting until 2040. US Patent 11,318,118 is entitled, “Methods and Compositions for treating SARS-CoV-2 infection using Carboxyamidotriazole Orotate.”
About Tactical Therapeutics, Inc
Tactical Therapeutics, Inc., is a privately funded company that has developed a patented lead therapeutic, CTO, for glioblastoma and other solid cancers. Proof-of-concept data have demonstrated effectiveness of CTO against cancers such as glioblastoma. Because the mechanism of action targets abnormal calcium signaling, CTO has the potential to control different stages of the viral cycle as well as influence immune dysregulation and tissue repair.
