VBL Therapeutics Treats First Patient in Phase 2 Randomized Controlled Study of VB-201 in COVID-19 Patients
January 27 2021 - 7:00AM
VBL Therapeutics (Nasdaq: VBLT) today announced the dosing of the
first patient in a randomized controlled Phase 2 study of the
Company’s proprietary investigational oral immune-modulator
molecule, VB-201 for the treatment of COVID-19. The study will
assess the ability of VB-201 to prevent clinical deterioration and
reduce morbidity and mortality in patients with severe COVID-19.
"While vaccines offer a major development in this
pandemic, there is still a crucial unmet global need for new
treatments for severe COVID patients," said Prof. Dror Harats,
Chief Executive Officer of VBL Therapeutics. "Manufacturing and
cold-chain logistics limit access to vaccines in many regions in
the world and at the same time, new and aggressive viral mutations
are being identified. There is an understanding that the
therapeutic arsenal against COVID must be enriched, both to combat
the current pandemic as well as for future viral outbreaks. We
believe that, as a safe and affordable oral therapy, VB-201 has the
potential to bridge this gap by limiting the life-threatening
hyper-inflammation in this deadly disease.”
VB-201 is designed to offer differentiation from other immune
modulators evaluated as treatments for COVID, and its
anti-inflammatory activity in the cardiovascular system may benefit
patients with COVID-related Kawasaki-like multisystem inflammatory
syndrome. Studied in over 600 subjects, VB-201 previously
demonstrated proof of concept in a Phase 2 study in vascular
inflammation, meeting the primary endpoint of the trial.
"Treating the immune system of COVID-19 patients requires a
delicate balance between preventing cytokine storm and suppressing
the body's ability to fight the virus," said Tami Rachmilewitz,
M.D., Vice President Clinical Development of VBL Therapeutics. "As
macrophages play a key role in the cytokine storm seen with
COVID-19, targeting their accumulation in the lungs represents an
encouraging strategy for curbing hyper-inflammation and tissue
damage. That is exactly what we are aiming to achieve with VB-201
in this study."
About VB-201VBL Therapeutics has developed
the `Lecinoxoids,` a novel class of investigational
orally-available anti-inflammatory small molecules. Lecinoxoids
mimic the structure of native phospholipid molecules that regulate
the inflammatory process. By modulating innate immunity, the
controller of the immune system, Lecinoxoids can potentially target
a spectrum of immune-inflammatory diseases including cardiovascular
diseases, NASH/liver fibrosis, renal fibrosis and others. Lead
candidate VB-201 is an oral small molecule that has been
administered to more than 600 patients, across eight clinical
trials. VB-201 works via inhibition of monocyte migration as well
as inhibition of the pro-inflammatory CD14/TLR4 and TLR2
pathways.
About VBLVascular Biogenics Ltd., operating
as VBL Therapeutics, is a clinical stage biopharmaceutical
company focused on the discovery, development and commercialization
of first-in-class treatments for areas of unmet need in cancer and
immune/inflammatory indications. For additional information visit:
www.vblrx.com.
Forward Looking StatementsThis press release
contains forward-looking statements. All statements other than
statements of historical fact are forward-looking statements, which
are often indicated by terms such as “anticipate,” “believe,”
“could,” “estimate,” “expect,” “goal,” “intend,” “look forward to,”
“may,” “plan,” “potential,” “predict,” “project,” “should,” “will,”
“would” and similar expressions. These forward-looking statements
include, but are not limited to, statements regarding our programs,
including VB-201, including their clinical development, such as the
timing of clinical trials and expected announcement of data,
therapeutic potential and clinical results, and our financial
position and cash runway. These forward-looking statements are not
promises or guarantees and involve substantial risks and
uncertainties. Among the factors that could cause actual results to
differ materially from those described or projected herein include
uncertainties associated generally with research and development,
clinical trials and related regulatory reviews and approvals, the
risk that historical clinical trial results may not be predictive
of future trial results, that our financial resources do not last
for as long as anticipated, and that we may not realize the
expected benefits of our intellectual property protection. A
further list and description of these risks, uncertainties and
other risks can be found in our regulatory filings with
the U.S. Securities and Exchange Commission, including in our
annual report on Form 20-F for the year ended December 31,
2019, and subsequent filings with the SEC. Existing and
prospective investors are cautioned not to place undue reliance on
these forward-looking statements, which speak only as of the date
hereof. VBL Therapeutics undertakes no obligation to
update or revise the information contained in this press release,
whether as a result of new information, future events or
circumstances or otherwise.
CONTACT:Burns McClellan for VBL
TherapeuticsLee Roth (investors) / Ryo Imai
(media)lroth@burnsmc.com / rimai@burnsmc.com+1-212-213-0006
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