Humanigen to Host Conference Call to Report Phase 3 Topline Results of LenzilumabTM in Patients Hospitalized With COVID-19
March 29 2021 - 6:00AM
Business Wire
Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), a clinical-stage
biopharmaceutical company focused on preventing and treating an
immune hyper-response called ‘cytokine storm’ with its lead drug
candidate, lenzilumab, announced that management will host a
conference call and webcast today at 8am ET to discuss topline
results from the Phase 3 clinical trial of lenzilumab in patients
hospitalized with COVID-19.
Details for the upcoming conference are below:
Webcast link:
https://78449.themediaframe.com/dataconf/productusers/hmg/mediaframe/44119/indexl.html
Dial by phone: U.S. 877-405-1224 or Int’l: 201-389-0848.
The webcast will be archived for 90 days under the Investor
Relations section of the company’s website at
www.humanigen.com.
About the Lenzilumab Phase 3 Study
This study was a randomized, double-blind, placebo-controlled,
multi-center Phase 3 trial for the treatment and prevention of
serious and potentially fatal outcomes in patients who were
hospitalized with COVID-19 pneumonia. The primary objective was to
assess whether lenzilumab, in addition to other treatments, which
included dexamethasone (or other steroids) and/or remdesivir, could
alleviate the immune-mediated cytokine release syndrome (CRS) and
improve ventilator-free survival. Ventilator-free survival is a
composite endpoint of time to death and time to IMV, which is a
robust measure that is less prone to favor a treatment with
discordant effects on survival or days free of ventilation. The
trial enrolled 520 patients in 29 sites in the US and Brazil who
were at least 18 years of age; experienced blood oxygen saturation
(SpO2) of less than or equal to 94%; or required low-flow
supplemental oxygen, or high-flow oxygen support, or non-invasive
positive pressure ventilation (NIPPV); and were hospitalized but
did not require IMV. Following enrollment, subjects were randomized
to receive three infusions of either lenzilumab or placebo, each
infusion separated by eight hours over a 24-hour period with other
treatments. The primary endpoint was the difference between
lenzilumab treatment and placebo treatment in ventilator-free
survival through 28 days following treatment. Key secondary
endpoints, also measured through 28 days, included ventilator-free
days, duration of ICU stay, incidence of invasive mechanical
ventilation, extracorporeal membrane oxygenation (ECMO), and/or
death, time to death, all-cause mortality, and time to recovery.
Results of the trial are planned to be submitted for potential
publication in a peer-reviewed journal.
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. Humanigen’s immediate focus is to prevent
or minimize cytokine release syndrome that precedes severe lung
dysfunction in hospitalized and hypoxic patients with COVID-19
pneumonia. Humanigen is also working to create 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, Humanigen 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.
Humanigen 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 and
follow Humanigen on LinkedIn, Twitter, and Facebook.
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version on businesswire.com: https://www.businesswire.com/news/home/20210329005183/en/
Humanigen Media Grace Catlett RXMD Gcatlett@rxmedyn.com
516-318-8563
Humanigen Investors Alan Lada Solebury Trout
ALada@SoleburyTrout.com 617-221-8006
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