Approval through the Brazilian Ministry of Health follows the approval of the IND granted through the FDA in the United States.
Brazil is a component of Humanigen’s global progression program for lenzilumab
Humanigen, Inc., (HGEN) (“Humanigen”), a clinical-stage biopharmaceutical company aimed at the prevention and remedy of the cytokine typhoon with lenzilumab, the exclusive monoclonal antibody Humaneered® anti-human colony-stimulating macrophage granulocytes (GM-CSF), announced that Brazilian regulatory agency Anvisa had granted permission to initiate a Phase III test on lenzilumab in patients with COVID-19 in Brazil.
The study, now expected to begin recruiting patients in Brazil, follows the same protocol approved by the U.S. Food and Drug Administration in April: a multicenter, randomized, placebo-controlled, double-blind clinical trial for severe and critically hospitalized adults. COVID-19. 19 patients at increased risk of disease progression. Humanigen is working with Clinical Trial Consulting (CTI), recently named as the world’s leading contract study organization, to conduct this test in Brazil.
Cameron Durrant, MD, MBA, Humanigen’s chief executive, said: “COVID-19 is a global crisis and we are committed to providing assistance to patients around the world affected by the pandemic. We hope that the expansion of lenzilumab will examine the study centers in Brazil, a country with emerging COVID-19 rates, will provide patients with a leading curative candidate for COVID-19 that they so badly need.”
Currently, Brazil has the highest rate of COVID-19 infection in the world, only the United States.
“Access to clinical trials is essential for fitness care providers in the fight against COVID-19,” said Timothy Schroeder, CTI’s chief executive. “We are proud to work with our humanigen colleagues to expand the scope of the Phase III lenzilumab exam and offer a prospective remedy option for those who wish.
More main points about Humanigen systems can be discovered at COVID-19 on the company’s online page at www.humanigen.com under tab COVID-19, and the main points of the prospective Phase III registration exam in the United States can be discovered on Clinicaltrials .gov ClinicalTrials.gov Identifier NCT04351152.
About Humanigen, Inc.
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. We believe that our GM-CSF neutralization and gene-editing platform technologies have the potential to reduce the inflammatory cascade associated with coronavirus infection. The company’s immediate focus is to prevent or minimize the cytokine release syndrome that precedes severe lung dysfunction and ARDS in serious cases of SARS-CoV-2 infection. The company is also focused on creating next-generation combinatory gene-edited CAR-T therapies using strategies to improve efficacy while employing GM-CSF gene knockout technologies to control toxicity. In addition, the company is developing its own portfolio of proprietary first-in-class EphA3-CAR-T for various solid cancers and EMR1-CAR-T for various eosinophilic disorders. The company is also exploring the effectiveness of its GM-CSF neutralization technologies (either through the use of lenzilumab as a neutralizing antibody or through GM-CSF gene knockout) in combination with other CAR-T, bispecific or natural killer (NK) T cell engaging immunotherapy treatments to break the efficacy/toxicity linkage, including to prevent and/or treat graft-versus-host disease (GvHD) in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). Additionally, Humanigen and Kite, a Gilead Company, are evaluating lenzilumab in combination with Yescarta® (axicabtagene ciloleucel) in patients with relapsed or refractory large B-cell lymphoma in a clinical collaboration. For more information, visit www.humanigen.com.
About CTI Clinical Trial and Consulting Services
CTI Clinical Trial and Consulting Services is a comprehensive, personal and full-service contract study organization (CRO), recently named 1 international CRO for its quality, providing a complete diversity of clinical trials and consulting facilities during the progression lifecycle, from concept to commercialization. CTI’s targeted healing technique provides pharmaceutical, biotechnological and medical device companies with clinical and pathological experience in rare diseases, regenerative medicine/gene therapy, immunology, transplants, nephrology, hematology/oncology, neurology, infectious diseases, hepatology, cardiopulmonary and pediatric populations. CTI also offers a fully built-in multi-specialty clinical studies site that conducts Phase I-IV trials. CTI has a hobby of helping life-changing treatments succeed in populations of patients with chronic and critical illnesses. With the delight of clinical trials on 6 continents, CTI partners with study centers, patients and sponsors to address unmet medical needs. CTI is headquartered in the Greater Cincinnati region of OH, with operations in North America, Europe, Latin America and Asia Pacific. For more information, scale www.ctifacts.com.
Forward-looking statements
This press release includes forward-looking statements. Forward-looking statements reflect existing knowledge, assumptions, judgment, and expectations of control related to functionality or long-term occasions. While the review believes that the expectations reflected in those statements are reasonable, they make no guarantee that those expectations will prove to be accurate and you deserve to be aware that actual occasions or effects may differ materially from the content contained in the forward-looking statements. Statements. Words like “will,” “waits,” “intention,” “plan,” “potential,” “possible,” “objectives,” “accelerate,” “continue, and similar expressions” refer to forward-looking statements, including: without limitation, statements related to our expectations related to our ongoing and planned clinical trial activities in the United States and Brazil and our operational, research, progression or marketing activities for lenzilumab and other candidate products in our current portfolio. Forward-looking statements are subject to a number of hazards and uncertainties, including but not limited to the dangers inherent in our lack of profitability and the need for additional capital to conduct the Phase III review and expand our business; our partner unit to continue the progression of our candidate products; Uncertainties inherent in the progression and release of any new pharmaceutical product; The final results of an ongoing or long-term litigation; and the hazards and uncertainties described in the “Risk Factors” sections and in other parts of the Company’s periodic and other submissions to the Securities and Exchange Commission.
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Contacts
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Investors Victoria Meissner, MDWestwicke, ICR [email protected] 646-677-1837
CTI Allison [email protected] 513-598-9290