Covington-based CTI Clinical Trial and Consulting Services has partnered with California-based Humanigen, Inc. on a study for the treatment of novel coronavirus 2019 (COVID-19).
Humanigen, Inc., (HGEN) (“Humanigen”), a clinical-stage biopharmaceutical company focused on preventing and treating cytokine storm with lenzilumab, the company’s proprietary Humaneered® anti-human-granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal antibody, announced that the company has submitted an initial protocol synopsis to the FDA in support of the company’s plans to initiate a multi-center, US, Phase III study in COVID-19 patients.
The study, if approved, will be a randomized, controlled, clinical trial with lenzilumab for the prevention of ARDS and/or death in hospitalized patients with pneumonia associated with coronavirus 2 (SARS-CoV-2) infection in COVID-19.
The study will be conducted in partnership with CTI, which specializes in complex programs for critically and chronically ill patients.
Humanigen, Inc. is developing its portfolio of clinical and pre-clinical therapies for the treatment of cancers and infectious diseases via its novel, cutting-edge GM-CSF neutralization and gene-knockout platforms.
“Humanigen has pioneered the field of GM-CSF neutralization and, unlike others, has already conducted two Phase I and two Phase II studies, including in patients with severe respiratory conditions, with excellent safety results,” said Dr. Cameron Durrant, chief executive officer of Humanigen. “We have been working on prevention of cytokine storm for nearly three years. Lenzilumab has an excellent safety and tolerability profile and has not been associated with serious adverse events, including in patients who are immunosuppressed or with severe asthma. Subject to discussion and agreement with regulatory authorities, we intend to progress as quickly as possible with this study.”
More details on the company’s programs in COVID-19 can be found on the company’s website under the COVID-19 tab.
CTI Clinical Trial and Consulting Services is a global, privately held, full-service contract research organization (CRO).
It delivers a complete spectrum of clinical trial and consulting services throughout the lifecycle of development, from concept to commercialization.
CTI’s focused therapeutic approach provides pharmaceutical, biotechnology, and medical device firms with clinical and disease area expertise in rare diseases, regenerative medicine/gene therapy, immunology, transplantation, nephrology, hematology/oncology, neurology, infectious diseases, hepatology, cardiopulmonary, and pediatric populations.
Schroeder
“The COVID-19 pandemic demands an unprecedented response from the pharmaceutical and biotechnology communities, requiring innovation, collaboration, and prioritization of speed without the cost of safety,” remarked Tim Schroeder, founder and CEO of CTI. “We are proud to have the opportunity to collaborate on such a response with the Humanigen team and to work together to develop an effective treatment solution for those hardest hit by COVID-19.”
CTI also offers a fully integrated multi-specialty clinical research site that conducts phase I-IV trials. CTI has a passion for helping life-changing therapies succeed in chronically and critically ill patient populations. With clinical trial experience across 6 continents, CTI partners with research sites, patients, and sponsors to fulfill unmet medical needs. CTI is headquartered in the Greater Cincinnati, OH area, with operations across North America, Europe, Latin America, and Asia-Pacific.
For more information on CTI, click here.
Study to tackle leading cause of death in COVID-19 patients
• Lenzilumab, a monoclonal antibody that neutralizes granulocyte macrophage colony stimulating factor (GM-CSF)
• GM-CSF is up-regulated in COVID-19 patients and may cause a harmful immune response leading to acute respiratory distress syndrome (ARDS)
• Clinical evidence suggests that this harmful immune response contributes to cytokine storm in COVID-19 patients at risk of developing ARDS
• Company plans to study lenzilumab in COVID-19 patients to prevent ARDS and mortality with CTI Clinical Trial and Consulting Services (CTI)
COVID-19 is an infectious disease caused by SARS-CoV-2. COVID-19 has become a global pandemic, with over 460,000 confirmed cases and over 21,000 deaths reported to date. Patients with severe cases of COVID-19 experience severe viral pneumonia that can progress to acute respiratory distress syndrome (ARDS) and death.
ARDS is an acute, life-threatening inflammatory lung injury characterized by hypoxia – a lack of oxygen to the tissue – and stiff lungs due to increased pulmonary vascular permeability. ARDS necessitates hospitalization and mechanical ventilation. A rapid increase in patients with ARDS presents a major challenge for the global public health system given limited hospital beds and ventilators. When implementing standard of care, including mechanical ventilation, ARDS has an overall mortality rate of greater than 40 percent.
Humanigen, Inc. study is focused on the belief that its GM-CSF neutralization and gene-editing platform technologies have the potential to reduce the inflammatory cascade associated with coronavirus infection as well as the serious and potentially life-threatening CAR-T therapy-related side effects while preserving and potentially improving the efficacy of the CAR-T therapy itself, thus breaking the efficacy/toxicity linkage.
The company’s immediate focus is to prevent or minimize the cytokine storm that precedes severe lung dysfunction and ARDS in cases of pneumonia-associated SARS-CoV-2 infection and also in combining FDA-approved and development stage CAR-T therapies with lenzilumab, the company’s proprietary Humaneered® anti-human-GM-CSF immunotherapy, which is its lead product candidate.
CTI
