ALZN002 is believed to be the first autologous dendritic
cell-based active immunotherapy vaccine candidate to be tested in
humans to treat Alzheimer’s
BitNile Holdings, Inc. (NYSE American: NILE), a diversified
holding company (“BitNile” or the “Company”) today
announced that Alzamend Neuro, Inc. (Nasdaq: ALZN)
(“Alzamend”), an early clinical-stage biopharmaceutical
company focused on developing novel products for the treatment of
Alzheimer’s disease (“Alzheimer’s”), bipolar disorder, major
depressive disorder and post-traumatic stress disorder, received a
“study may proceed” letter from the U.S. Food and Drug
Administration (“FDA”) for a Phase I/IIA clinical trial
under Alzamend’s Investigational New Drug (“IND”)
application for an immunotherapy vaccine (ALZN002) to treat mild to
moderate dementia of the Alzheimer’s type.
ALZN002 is believed to be the first candidate autologous (uses
the patient’s own cells) dendritic cell-based Alzheimer’s
immunotherapy vaccine to be tested in humans that potentially
fosters tolerance to treatment (for safety) while providing durable
active immunity potential and fewer physician visits compared to
passive (foreign to the patient) immunity treatments.
Alzamend reported that it expects to initiate the clinical trial
in the first quarter of 2023. BitNile is a significant beneficial
owner of Alzamend common stock.
About ALZN002
ALZN002 is a proprietary “active” immunotherapy product, which
means it is produced by each patient’s immune system. It consists
of autologous dendritic cells (“DCs”), which are activated
white blood cells taken from each individual patient that are then
engineered outside of the body to attack Alzheimer’s-related
amyloid-beta proteins. These DCs are pulsed with a novel
amyloid-beta peptide designed to bolster the ability of the
patient’s immune system to combat Alzheimer’s. The goal of this
treatment approach is to foster tolerance to treatment for safety
purposes while stimulating the immune system to reduce the brain’s
beta-amyloid protein burden, resulting in reduced Alzheimer’s signs
and symptoms.
The ALZN002 DC treatment is, by definition, an
individual-patient-specific therapy since these autologous DCs are
administered to the same patient from whom they were removed. Each
patient will undergo leukapheresis, i.e., removal and return to the
body of white blood cells. This procedure will isolate each
patient’s peripheral blood monocytes from the obtained white blood
cells. These are subsequently differentiated outside the body into
DCs that are engineered to induce immunogenicity (search and
destroy capability) towards amyloid, the protein associated with
Alzheimer’s in the patient’s body, but to be otherwise tolerated as
natural to the body to avoid adverse side effects.
Compared to passive immunization treatment approaches that use
foreign blood products (such as monoclonal antibodies), active
immunization with ALZN002 is anticipated to offer a more robust and
long-lasting effect on the clearance of amyloid. This is expected
to provide a safe and effective treatment for Alzheimer’s sufferers
that requires considerably less frequent treatment visits compared
to passive immunity approaches.
The IND supports initial deployment of a Phase I/IIA clinical
trial, ALZN002-01, a first-in-human, randomized, double-blind,
placebo-controlled, parallel-group study. The purpose of this trial
will be to assess the safety, tolerability, and efficacy of
multiple ascending doses of ALZN002 compared with that of placebo
in 20 to 30 subjects with mild to moderate dementia of the
Alzheimer’s type. Also, the trial will be designed to determine the
optimal dosage of ALZN002 for treatment of patients with
Alzheimer’s in a larger Phase IIB efficacy and safety clinical
trial (ALZN002-02), which Alzamend expects to initiate within three
months of receiving data from the initial trial.
Milton “Todd” Ault, III, the Company’s Executive Chairman and
the Founder and Chairman Emeritus of Alzamend, stated, “I could not
be more pleased with the FDA’s ‘Study May Proceed’ allowing
Alzamend to begin to test its immunotherapy vaccine in patients
with Alzheimer’s. It has been a life-long goal of mine to help
people suffering from Alzheimer’s. I believe that a vaccine will
play the biggest role in the fight against Alzheimer’s.”
The Company has certain beneficial ownership and rights to
further invest in Alzamend. The Company beneficially owns
approximately 10.4 million shares and has the right to acquire 3.4
million shares of Alzamend common stock upon the exercise of
warrants. In addition, the Company’s wholly owned subsidiary, Ault
Lending, LLC, has the right to purchase up to an additional 6.67
million shares at $1.50 per share with warrants to purchase 3.3
million of shares of Alzamend common stock at an exercise price of
$3.00 per share.
Should the Company exercise all warrants and options to invest,
it would own approximately 23.8 million shares with an average cost
of $2.02 per share of common stock, representing 22% of Alzamend’s
issued and outstanding common stock.
For more information on BitNile and its subsidiaries, BitNile
recommends that stockholders, investors, and any other interested
parties read BitNile’s public filings and press releases available
under the Investor Relations section at www.BitNile.com or
available at www.sec.gov.
About BitNile Holdings, Inc.
BitNile Holdings, Inc. is a diversified holding company pursuing
growth by acquiring undervalued businesses and disruptive
technologies with a global impact. Through its wholly and
majority-owned subsidiaries and strategic investments, BitNile owns
and operates a data center at which it mines Bitcoin and provides
mission-critical products that support a diverse range of
industries, including oil exploration, defense/aerospace,
industrial, automotive, medical/biopharma, karaoke audio equipment,
hotel operations and textiles. In addition, BitNile extends credit
to select entrepreneurial businesses through a licensed lending
subsidiary. BitNile’s headquarters are located at 11411 Southern
Highlands Parkway, Suite 240, Las Vegas, NV 89141;
www.BitNile.com.
Forward-Looking Statements
This press release contains “forward-looking statements” within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. These forward-looking statements generally include
statements that are predictive in nature and depend upon or refer
to future events or conditions, and include words such as
“believes,” “plans,” “anticipates,” “projects,” “estimates,”
“expects,” “intends,” “strategy,” “future,” “opportunity,” “may,”
“will,” “should,” “could,” “potential,” or similar expressions.
Statements that are not historical facts are forward-looking
statements. Forward-looking statements are based on current beliefs
and assumptions that are subject to risks and uncertainties.
Forward-looking statements speak only as of the date they are made,
and the Company undertakes no obligation to update any of them
publicly in light of new information or future events. Actual
results could differ materially from those contained in any
forward-looking statement as a result of various factors. More
information, including potential risk factors, that could affect
the Company’s business and financial results are included in the
Company’s filings with the U.S. Securities and Exchange Commission,
including, but not limited to, the Company’s Forms 10-K, 10-Q and
8-K. All filings are available at www.sec.gov and on the Company’s
website at www.BitNile.com.
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BitNile Holdings Investor Contact: IR@BitNile.com or
1-888-753-2235
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