Humanigen Announces First Patient Dosed at MedStar Washington Hospital Center in Phase 3 Clinical Study of Lenzilumab in COVI...
October 30 2020 - 02:05PM
Business Wire
- New study site actively enrolling eligible hospitalized
patients with COVID-19 in clinical trial in Washington,
D.C.
Humanigen, Inc. (HGEN) (“Humanigen”), a clinical stage
biopharmaceutical company focused on preventing and treating an
immune hyper-response called ‘cytokine storm’ with lenzilumab,
today announced that MedStar Washington Hospital Center in
Washington, D.C. treated its first COVID-19 patient with
lenzilumab. The primary goal of this Phase 3 randomized,
double-blind, multicenter, placebo-controlled clinical trial is to
determine if lenzilumab can help hospitalized patients with
COVID-19 recover faster. As many as 89% of hospitalized patients
with COVID-19 are at risk of a complication called cytokine storm,
a harmful inflammation that has been the leading cause of COVID-19
death. MedStar Washington Hospital Center is one of 18 sites in the
U.S. approved to enroll eligible patients to study lenzilumab,
designed specifically to stop this storm. Eligible patients can
participate in this trial while also receiving other
standard-of-care therapies as recommended by their treating
physician.
“Given the growing number of cases in the D.C. area seen in the
past few weeks, we were particularly motivated to ensure our Phase
3 study was enrolling and accessible,” said Cameron Durrant, MD,
MBA, chief executive officer of Humanigen. “We have been impressed
with the hospital leadership and trial investigators at MedStar
Washington, and worked together with speed and efficiency to get
this trial location ready to enroll patients.”
For more information on participating in the Phase 3 COVID-19
trial of lenzilumab, please visit StopStorm.com, and talk to your
doctor to see if you may be eligible to participate.
More details on Humanigen’s programs in COVID-19 can be found on
the Company’s website at www.humanigen.com under the COVID-19 tab,
and details of the U.S. Phase 3 potential registration study can be
found at clinicaltrials.gov using 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.
Forward-Looking Statements
This release contains forward-looking statements.
Forward-looking statements reflect management's current knowledge,
assumptions, judgment and expectations regarding future performance
or events. Although management believes that the expectations
reflected in such statements are reasonable, they give no assurance
that such expectations will prove to be correct and you should be
aware that actual events or results may differ materially from
those contained in the forward-looking statements. Words such as
"will," "expect," "intend," "plan," "potential," "possible,"
"goals," "accelerate," "continue," and similar expressions identify
forward-looking statements, including, without limitation,
statements regarding our expectations for the Phase 3 study and the
potential future development of lenzilumab, our pathway to our
intended submission for, and potential receipt of, an Emergency Use
Authorization and potential subsequent BLA from FDA, and statements
regarding the potential for lenzilumab to be used to prevent or
treat GvHD and, as sequenced therapy with Kite’s Yescarta, in CAR-T
therapies. Forward-looking statements are subject to a number of
risks and uncertainties including, but not limited to, the risks
inherent in our lack of profitability; our dependence on partners
to further the development of our product candidates; the costs and
the uncertainties inherent in the development and launch of any new
pharmaceutical product; the outcome of pending or future
litigation; and the various risks and uncertainties described in
the "Risk Factors" sections and elsewhere in the Company's periodic
and other filings with the Securities and Exchange Commission.
All forward-looking statements are expressly qualified in their
entirety by this cautionary notice. You should not place undue
reliance on any forward-looking statements, which speak only as of
the date of this release. We undertake no obligation to revise or
update any forward-looking statements made in this press release to
reflect events or circumstances after the date hereof or to reflect
new information or the occurrence of unanticipated events, except
as required by law.
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Media Cammy Duong Westwicke, an ICR company
cammy.duong@westwicke.com 203-682-8380
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