PLANO, TX / ACCESSWIRE /
September 16, 2020 / Enzolytics,
Inc. (OTC PINK:ENZC or the "Company") today announced
the execution of a non-binding letter of intent (the
"LOI") to merge with BioClonetics Immunotherapeutics,
Inc. ("BCLS" or "BioClonetics") a biotech company
located in Dallas Texas.
BioClonetics is in the final stage of development of a
parent monoclonal antibody ("mAbs") (designated as Clone
3), which is non-toxic and has shown in initial in
vitro testing to be effective against
more than 95% of all strains and viral subtypes of HIV-1
against which it has been tested. [http://www.bioclonetics.com/validation.html].
Final testing of BioClonetics' anti-HIV recombinant mAbs
in PBMC neutralization assays are being conducted to be
followed by animal trials at the California National
Primate Research Center, UCDavis (Davis, CA).
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The
BioClonetics Clone 3 recombinant mAbs will be combined
with the Enzolytics' flagship compound ITV-1 which is a
suspension of Inactivated Pepsin Fragment (IPF), which
studies have shown is effective in the treatment of HIV.
IPF is the active drug substance of ITV-1 and is a
purified extract of porcine pepsin. ITV-1 has been shown
to modulate the immune system. IPF is a platform
technology that can be used to facilitate a broad range
of applications. It is free from major neurological,
gastrointestinal and hematological side effects seen in
the anti-retrovirals in use today. IPF has been shown to
not be subject to viral resistance and is cost effective.
The
Companies plan to conduct binding studies combining the
therapeutics produced by both companies to evaluate the
beneficial effects and increased binding capability of
the BioClonetics Clone 3 antibodies to multiple HIV
isolates.
Thereafter, PBMC based in-vitro neutralization
studies will be conducted with the Enzolytics ITV-1
peptide in combination with the BioClonetics Clone 3
antibodies. Based on the results, the best combination
with be tested in primate studies at the California
National Primate Research Center University of
California, Davis, California.
With its technology for producing fully human monoclonal
antibodies against numerous infectious diseases viruses,
including those targeting the HIV-1 virus [http://www.bioclonetics.com/effectiveness.html]
and recognizing a significant correlative structure
between the HIV virus and the SARS-CoV-2 (COVID-19)
virus, BioClonetics has been invited by the National
Science Foundation (NSF) to submit an application for
funding for development of anti-SARS-Cov-2 monoclonal
antibodies using its proprietary technology. Such
application to the NSF and a corresponding application
to the NIH are now pending.
ENZC is in the process of compiling the information to
bring current its OTC filings. The company has several
additional initiatives which it will work towards the
remainder of 2020 and into 2021. The company has begun
the process of identifying a clinical research
organization for the preparation of pre-IND protocols
for submission to the FDA.
The
Company is also looking to expand its medical advisory
board with individuals that have direct experience
taking medical products through the regulatory process
and bringing them to market. The Company's intent is to
take the ITV-1 treatment, which has already successfully
completed Phase III clinical trials at the Specialized
Hospital for Active Treatment of Infectious and Parasite
Diseases in Sofia, Bulgaria, through the permitting
process and begin the process of gaining regulatory
approval with the FDA in the United States.
The
proposed merger anticipated in the non-binding LOI will
result in Charles Cotropia being appointed as CEO of the
merged entity and Harry Zhabilov and Joseph Cotropia,
MD, being appointed as co-CSO. Gaurav Chandra, MD, will
serve as COO of the merged entity. Additional details
will be disclosed as the transaction progresses.
"The combination of our two companies' proprietary
technologies and products is a once in a lifetime
opportunity that should benefit both of our
organizations letting us achieve more together than we
could apart", stated Harry Zhabilov, CEO of ENZC.
Charles Cotropia, CEO of BioClonetics added, "Our
proprietary methodology may also be applied to produce
monoclonal antibodies against other infectious diseases
and the invitation by the National Science Foundation
(NSF) to apply for funding to further BioClonetics
efforts to develop an anti-SARS-Cov-2 monoclonal
antibodies using our proprietary technology is an
exciting development for BioClonetics. We have
previously produced monoclonal antibodies against HIV,
rabies, influenza A, influenza B, tetanus and
diphtheria. We look forward to discovering how ENZC's
ITV-1 treatment can be used with our monoclonal antibody
platform to synergistically improve our such antibodies
for treating HIV."
About Enzolytics, Inc;
Enzolytics, Inc. is a drug development company committed
to the commercialization of its proprietary proteins for
the treatment of debilitating infectious diseases.
Immunotech is committed to creating drugs for the better
health of mankind.
Enzolytics' flagship compound ITV-1 (Immune Therapeutic
Vaccine-1) is a suspension of Inactivated Pepsin
Fraction (IPF), which studies have shown is effective in
the treatment of HIV/AIDS. IPF is the active drug
substance of ITV-1 and is a purified extract of porcine
pepsin. ITV-1 has been shown to modulate the immune
system.
About BioClonetics Immunotherapeutics, Inc.
BioClonetics Immunotherapeutics, Inc. is a Dallas Texas
biotech company with proprietary technology for
producing fully human monoclonal antibodies (mAbs)
against infectious diseases including HIV, rabies,
influenza A, influenza B, tetanus, and diphtheria. Its
proprietary methodology for produce fully human
monoclonal antibodies may be use to produce therapeutics
treatments for name infectious diseases including the
Coronavirus.
Safe Harbor Statement: This news
release contains forward-looking statements that involve
risks and uncertainties associated with financial
projections, budgets, milestone timelines, clinical
development, regulatory approvals, and other risks
described by Enzolytics, Inc. (f/k/a Eco Petroleum
Solutions, Inc. / Immunotech Laboratories, Inc.) from
time to time in its periodic reports filed with the SEC.
IPF is not approved by the US Food and Drug
Administration or by any comparable regulatory agencies
elsewhere in the world.
While Enzolytics, Inc. believes that the forward-looking
statements and underlying assumptions contained therein
are reasonable, any of the assumptions could be
inaccurate, including, but not limited to, the ability
of Enzolytics to establish the efficacy of IPF in the
treatment of any disease or health condition, the
development of studies and strategies leading to
commercialization of IPF in the United States, the
obtaining of funding required to carry out the
development plan, the completion of studies and tests on
time or at all, and the successful outcome of such
studies or tests. Therefore, there can be no assurance
that the forward-looking statements included in this
release will prove to be accurate.
Such forward-looking statements are based on current
expectations and involve inherent risks and
uncertainties, including factors that could delay,
divert or change any of the statements made, and could
cause actual outcomes and results to differ materially
from current expectations. No forward-looking statement
can be guaranteed. These forward-looking statements are
made as of the date of this press release, and the
Company expressly disclaims any intention or obligation
to update the forward-looking statements, or to update
the reasons why actual results could differ from those
projected in the forward-looking statements.