CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the
“Company"), a late-stage biotechnology company developing
Vyrologix™ (leronlimab-PRO 140), a CCR5 antagonist with the
potential for multiple therapeutic indications, announced that its
Brazilian distribution partner, Biomm S.A. (BVMF: BIOM3), plans to
submit an authorization request to the Brazilian National Health
Surveillance Agency (“ANVISA”) in the next few days to conduct two
Phase 3 clinical trials of leronlimab in Brazil for COVID-19. The
two Phase 3 trials consist of trials for each severe and critically
ill COVID-19 patients. Once approved by ANVISA, the Phase 3 trials
will be conducted by Albert Einstein Israelite Hospital, an
Academic Research Organization in Brazil.
The COVID-19 trials in Brazil are intended to provide ANVISA
with the requisite data to consider advancing the availability of
leronlimab to thousands of Brazilians infected with COVID-19. These
two Phase 3 trials will be conducted in up to 45 clinical sites.
The critically ill protocol is for 306 patients while the severe
protocol is for 594 patients, and interim analysis for both
populations will be conducted when enrollment reaches about 40% of
the total number for each trial.
Nader Pourhassan, Ph.D., President and Chief Executive Officer
of CytoDyn, stated, “We continue to be grateful to Mr. Marchezini
and his team at Biomm for expediting our efforts to advance the
availability of leronlimab for all patients who might benefit from
this immune modulator product. We look forward to continuing to
identify partnerships in other countries experiencing a surge in
COVID-19 cases similar to Brazil, the Philippines and India where
leronlimab could potentially save lives. We will update investors
on the next investment community call on the design of these trials
based on the wealth of information we have learned from our
previous COVID-19 trials.”
About Biomm S.A.Biomm's mission is to develop,
produce and market global competitive biomedicines with quality and
accessibility. The company's focus is developing biological
products, aiming to guarantee national self-sufficiency. Due to its
innovator DNA, the company is pioneer in biotechnological drugs in
Brazil. Founded in 2002, Biomm’s headquarters and factory are in
Nova Lima (MG), with capacity to produce 20 million of insulin per
year, based on advanced and innovative technologies that guarantee
the medicines quality. The company is listed on the Brazilian stock
exchange (BVMF: BIOM3). For further information access
www.biomm.com
About Vyrologix™ (Leronlimab - PRO
140)The U.S. Food and Drug Administration (FDA) granted
CytoDyn Fast Track designation to explore two potential indications
using leronlimab to treat HIV and metastatic cancer. The first
indication is combination therapy with HAART for HIV-infected
patients, and the second is for metastatic triple-negative breast
cancer (mTNBC). Leronlimab is an investigational humanized IgG4 mAb
that blocks CCR5, a cellular receptor important in HIV infection,
tumor metastases, and other diseases, including NASH (nonalcoholic
steatohepatitis). Leronlimab has been studied in 11 clinical
trials involving more than 1,200 people and met its primary
endpoints in a pivotal Phase 3 trial (leronlimab combined with
standard antiretroviral therapies in HIV-infected
treatment-experienced patients).
Leronlimab is a viral-entry inhibitor in HIV/AIDS. It masks
CCR5, thus protecting healthy T cells from viral infection by
blocking the predominant HIV (R5) subtype from entering those
cells. Nine clinical trials have demonstrated leronlimab could
significantly reduce or control HIV viral load in humans. The
leronlimab antibody appears to be a powerful antiviral agent with
fewer side effects and less frequent dosing requirements than
currently used daily drug therapies. Cancer research has shown
CCR5 may play a role in tumor invasion, metastases, and tumor
microenvironment control. Increased CCR5 expression is an indicator
of disease status in several cancers. Published studies have shown
blocking CCR5 can reduce tumor metastases in laboratory and animal
models of aggressive breast and prostate cancer. Leronlimab reduced
human breast cancer metastasis by more than 98% in a murine
xenograft model. As a result, CytoDyn is conducting two Phase 2
human clinical trials, one in mTNBC, which was granted Fast Track
designation by the FDA in 2019, and a second in a basket trial
which encompasses 22 different solid tumor cancers.
The CCR5 receptor appears to play a central role in modulating
immune cell trafficking to sites of inflammation. After completing
two clinical trials with COVID-19 patients (a Phase 2 and a Phase
3), CytoDyn initiated a Phase 2 investigative trial for post-acute
sequelae of SARS COV-2 (PASC), also known as COVID-19 Long-Haulers.
This trial will evaluate the effect of leronlimab on clinical
symptoms and laboratory biomarkers to further understand the
pathophysiology of PASC. It is currently estimated that between
10-30% of those infected with COVID-19 develop long-term sequelae.
Common symptoms include fatigue, cognitive impairment, sleep
disorders, and shortness of breath. If this trial is successful,
CytoDyn plans to pursue clinical trials to evaluate leronlimab’s
effect on immunological dysregulation in other post-viral
syndromes, including myalgic encephalomyelitis/chronic fatigue
syndrome (ME/CFS).
CytoDyn is also conducting a Phase 2 clinical trial for NASH to
evaluate the effect of leronlimab on liver steatosis and fibrosis.
Preclinical studies revealed a significant reduction in NAFLD and a
reduction in liver fibrosis using leronlimab. There are currently
no FDA approved treatments for NASH. NASH is a leading cause of
liver transplant. About 30 to 40 percent of adults in the U.S. live
with NAFLD, and 3 to 12 percent of adults in the U.S. live with
NASH. There have been no strong safety signals identified in
patients administered leronlimab in multiple disease spectrums,
including patients with HIV, COVID-19 and Oncology.
About CytoDyn CytoDyn is a late-stage
biotechnology company developing innovative treatments for multiple
therapeutic indications using leronlimab, a novel humanized
monoclonal antibody targeting the CCR5 receptor. CCR5 appears to
play a critical role in the ability of HIV to enter and infect
healthy T-cells and appears to be implicated in tumor metastasis
and immune-mediated illnesses, such as NASH.
CytoDyn successfully completed a Phase 3 pivotal trial using
leronlimab combined with standard antiretroviral therapies in
HIV-infected treatment-experienced patients. CytoDyn has been
working diligently to refile its Biologics License Application
("BLA") for this HIV combination therapy since receiving a Refusal
to File in July 2020 and subsequently meeting with the FDA
telephonically to address their written guidance concerning the
filing. CytoDyn expects to refile its BLA in the first half of the
calendar year 2021 or shortly thereafter. CytoDyn also completed a
Phase 2/b3 investigative trial with leronlimab used as a
once-weekly monotherapy for HIV-infected patients. CytoDyn plans to
initiate a registration-directed study of leronlimab monotherapy
indication. If successful, it could support a label extension
approval. Several patients on leronlimab’s Phase 2b/3 monotherapy
extension arm have remained virally suppressed for more than six
years.
CytoDyn is also conducting a Phase 2 clinical trial with
leronlimab in mTNBC, a Phase 2 basket trial in solid tumor cancers
(22 different cancer indications), Phase 2 investigative trial for
post-acute sequelae of SARS COV-2, also known as COVID-19
Long-Haulers, and a Phase 2 clinical trial for NASH. CytoDyn has
already completed two trial in COVID-19 patients (a Phase 2 and a
Phase 3). More information is at www.cytodyn.com.
Forward-Looking Statements This press
release contains certain forward-looking statements that involve
risks, uncertainties and assumptions that are difficult to
predict. Words and expressions reflecting optimism,
satisfaction or disappointment with current prospects, as well as
words such as "believes," "hopes," "intends," "estimates,"
"expects," "projects," "plans," "anticipates" and variations
thereof, or the use of future tense, identify forward-looking
statements, but their absence does not mean that a statement is not
forward-looking. Forward-looking statements specifically include
statements about leronlimab, its ability to provide positive health
outcomes, the possible results of clinical trials, studies or other
programs or ability to continue those programs, the ability to
obtain regulatory approval for commercial sales, and the market for
actual commercial sales. The Company's forward-looking statements
are not guarantees of performance, and actual results could vary
materially from those contained in or expressed by such statements
due to risks and uncertainties including: (i) the sufficiency of
the Company's cash position, (ii) the Company's ability to raise
additional capital to fund its operations, (iii) the Company's
ability to meet its debt obligations, if any, (iv) the Company's
ability to enter into partnership or licensing arrangements with
third parties, (v) the Company's ability to identify patients to
enroll in its clinical trials in a timely fashion, (vi) the
Company's ability to achieve approval of a marketable product,
(vii) the design, implementation and conduct of the Company's
clinical trials, (viii) the results of the Company's clinical
trials, including the possibility of unfavorable clinical trial
results, (ix) the market for, and marketability of, any product
that is approved, (x) the existence or development of vaccines,
drugs, or other treatments that are viewed by medical professionals
or patients as superior to the Company's products, (xi) regulatory
initiatives, compliance with governmental regulations and the
regulatory approval process, (xii) general economic and business
conditions, (xiii) changes in foreign, political, and social
conditions, and (xiv) various other matters, many of which are
beyond the Company's control. The Company urges investors to
consider specifically the various risk factors identified in its
most recent Form 10-K, and any risk factors or cautionary
statements included in any subsequent Form 10-Q or Form 8-K, filed
with the Securities and Exchange Commission. Except as required by
law, the Company does not undertake any responsibility to update
any forward-looking statements to take into account events or
circumstances that occur after the date of this press release.
CONTACTS
Investors: Cristina De LeonOffice:
360.980.8524cdeleon@cytodyn.com
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