BURLINGAME, CA / ACCESSWIRE / August 10, 2020 / Humanigen, Inc., (OTCQB: HGEN) (“Humanigen”), a clinical-level biopharmaceutical company aimed at the prevention and remedy of cytokine typhoon with lenzilumab, the antihuman Humaneered® exclusive to the company The MONOclonal antibody GM-CSF (stimulating factor of colonies of granulocytes and macrophages), announced that the Brazilian regulatory agency, Anvisa, has granted permission to initiate a phase III examination 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 second highest reported rates of COVID-19 infection in the world, second only to the US.
“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 expanding its portfolio of clinical and preclinical remedies for the treatment of cancers and infectious diseases through its new genetic neutralization and GM-CSF platforms. We believe that our GENE-gene editing and GM-CSF neutralization platform technologies have the potential to decrease the inflammatory cascade related to coronavirus infection. The company’s immediate goal is to save it or minimize cytokine release syndrome that precedes severe lung disorder and SED in severe cases of SARS-CoV-2 infection. The company is also focusing on creating next-generation car-T mixing remedies published through genes that employ power-enhancing methods while employing GM-CSF gene deactivation technologies to control toxicity. In addition, the company is developing its own exclusive EphA3-CAR-T portfolio for various counterfeit cancers and EMR1-CAR-T for various eosinophil disorders. The company is also exploring the effectiveness of its GM-CSF neutralization technologies (either by using lenzilumab as a GM-CSF gene neutralizer or knockout) in mixture with other T-CAR-T, b-specific or herbicide (NK) T mobiles. initiate immunotherapy remedies to cut the bond into efficacy/toxicity, adding to save it and/or treat graft-versus-host disease (CHD) in patients undergoing a mobile allogeneic hematopoietic stem transplant (GCSH). In addition, Humanigen and Kite, a Gilead company, compare lenzilumab in mixture with Yescarta® (ciloleucel axicabtagen) in patients with giant relapsed or refractory mobile lymphoma B in clinical collaboration. For more information, scale www.humanigen.com.
About CTI’s Clinical Trials and Consultation 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 those 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.
All forward-looking statements are expressly qualified in their entirety through this warning. You deserve not to place undue reliance on forward-looking statements, which relate only to the date of this release. We assume no legal responsibility to revise or update the forward-looking statements made in this press release to reflect occasions or cases after the date of this fact or to reflect new data or the occurrence of unforeseen occasions, as required by law.
CONTACTS:
Media
Sean LeousWestwicke, an ICR [email protected]
Investors
Victoria Meissner, MDWestwicke, ICR [email protected] 646-677-1837
Cti
Allison [email protected] 513-598-9290
SOURCE: Humanigen, Inc.