PHARMADRUG
ADVANCES
PRODUCT
AND CLINICAL
DEVELOPMENT OF CEPHARANTHINE TO TREAT RARE CANCERS AND INFECTIOUS
DISEASES
Toronto,
Ontario--(Newsfile Corp. - April 20,
2021) -
InvestorsHub NewsWire - PharmaDrug Inc. (CSE: BUZZ) (OTC: LMLLF) ("PharmaDrug"
or the "Company"),
a
specialty pharmaceutical company focused on the research,
development and commercialization of controlled-substances and
natural medicines such as psychedelics, cannabis and
naturally-derived approved drugs, is pleased to announce that the
Company has entered into an agreement with Southwest Research
Institute® ("SwRI®"), to initiate non-clinical and
clinical manufacturing of Cepharanthine for the Company's rare
cancer and infectious diseases programs.
In connection with
PharmaDrug's recent acquisition of Sairiyo Therapeutics Inc., the
Company has secured an exclusive license from SwRI to
develop and commercialize a novel oral formulation of
Cepharanthine for all fields of use as well as exclusive rights to U.S.
Patent: 10,576,077, titled "Pharmaceutical Salt forms of
Cepharanthine and Tetrandrine". Formalization of the current
relationship will allow PharmaDrug to expedite development
timelines by leveraging SwRI's existing Cepharanthine preclinical
data sets and considerable manufacturing know-how.
Cepharanthine
is
a natural product
and an approved drug used for more than 70 years in Japan
to
successfully treat a variety of acute and
chronic diseases. In clinical research, Cepharanthine
has been shown
to exhibit
multiple pharmacological properties including anti-oxidative,
anti-inflammatory, immuno-regulatory, anti-cancer, anti-viral and
anti-parasitic properties.1 However,
historically
Cepharanthine's
low
oral
bioavailability
has represented a
major obstacle to realizing its full clinical
potential.
The Company is
focused on advancing the clinical development of an improved oral
formulation of Cepharanthine to treat rare cancers and
infectious diseases. Compared to generic
Cepharanthine, PharmaDrug's
novel
formulation has been shown in rodent and non-rodent
models to
possess markedly superior bioavailability (more easily
absorbed). These findings support the
development of an orally administered formulation, and in so doing,
removes the undesirable requirement for frequent intravenous
dosing.
Cepharanthine
and Cancer
The
antineoplastic properties of Cepharanthine are widely
described in peer reviewed literature1,2.
Based on compelling
preclinical data in esophageal cancer and a streamlined path to
approval which comes by way of a recently granted FDA Orphan Drug
Designation, the Company continues its plans to pursue
Cepharanthine for this indication. In parallel, the Company will
initiate high throughput studies to screen a large panel of
additional cancers with the aim of identifying additional types of
cancer sensitive to the effects of Cepharanthine-alone
(monotherapy), or when combined with first and second-line
chemotherapy drugs. It is expected that these studies will provide
the mechanistic understanding to rationally define a clinical lead
program in oncology while also affording the opportunity to secure
additional intellectual property around novel findings.
Cepharanthine
and Covid-19
Recently, to
rapidly identify drug candidates and provide patients with 'off the
shelf' treatments for Covid-19, two independent research groups
screened approximately 3,000 already approved
agents in
differing cell culture models of
SARS-CoV-2 infection3,4
and have recently
published the results. In both cases, Cepharanthine
was identified as the most promising lead; showing greater potency
at inhibiting infection than existing clinical development
candidates remdesivir and chloroquine3.
Moreover, Cepharanthine was also found to block viral cell entry of
lab-attenuated SARS-CoV and the virus that causes Middle East
respiratory syndrome (MERS)4.
The anti-viral mechanism of action for Cepharanthine is mediated
primarily through direct binding to the virus spike protein; the
presence of which is required for viral entry into the cell. The
authors note that while interesting, the poor oral bioavailability
of generic Cepharanthine would necessitate intravenous
administration and would limit patient access3.
The Company intends to capitalize on these findings by evaluating
the benefit of their novel oral formulation of Cepharanthine in an
animal model of SARS-CoV-2 infection. As a potential oral antiviral
therapeutic agent to treat mild-moderate Covid-19, the Company will
proceed to initiate discussions with health regulators, such as the
FDA and Health Canada, to determine the appropriate next steps to
advance to human clinical studies that would position Cepharanthine
as a potential first-in-class therapeutic against coronaviruses and
future pandemics.
Daniel Cohen, CEO
of PharmaDrug commented, "We are extremely
excited about Cepharanthine and its immense potential. We are
working diligently to advance the drug for Esophageal cancer while
simultaneously assessing its potential in other rare cancers. We
are also determining our mode of action relating to the drug's
apparent potential in treating Covid-19."
The
Company would
like to make it clear that is
not making any express or implied claims that its product
(Cepharanthine) has the
ability to treat,
eliminate
or cure COVID-19 (SARS-2 Coronavirus) and/or
other
infectious diseases at this time.
About
PharmaDrug Inc.
PharmaDrug is a
specialty pharmaceutical company focused on the research,
development and commercialization of controlled-substances and
natural medicines such as psychedelics, cannabis and
naturally-derived approved drugs. The Company owns 80% of
Pharmadrug Production GmbH, a German medical cannabis distributor,
with a Schedule I European Union narcotics license and German EuGMP
certification allowing for the importation and distribution of
medical cannabis to pharmacies in Germany and throughout the EU.
The Company also owns 100% of Super Smart, a Dutch company building
a modern adult use psychedelic retail business with an elevated and
educational focus. PharmaDrug recently acquired Sairiyo
Therapeutics, a biotech company that specializes in researching and
reformulating established natural medicines with a goal of bringing
them through regulatory and research driven clinical
trials.
For further information, please
contact:
Daniel Cohen, Chairman and
CEO
dcohen@pharmadrug.co
(647) 202-1824
Caution Regarding
Forward-Looking Information:
THE CANADIAN SECURITIES
EXCHANGE HAS NOT REVIEWED NOR DOES IT ACCEPT RESPONSIBILITY FOR THE
ADEQUACY OR ACCURACY OF THIS RELEASE.
This press
release contains "forward-looking information" within the meaning
of applicable securities legislation. All statements, other than
statements of historical fact, included herein are
forward-looking
information. Generally, forward-looking information may be
identified by the use of forward-looking terminology such as
"plans", "expects" or "does not expect", "proposed", "is expected",
"budgets", "scheduled", "estimates", "forecasts", "intends",
"anticipates" or "does not anticipate", or "believes", or
variations of such words and phrases, or by the use of words or
phrases which state that certain actions, events or results may,
could, would, or might occur or be achieved. In particular, this
press release contains forward-looking information in relation
to: the timing
of the proposed non-clinical
and clinical manufacturing of Cepharanthine for the Company's rare
cancer and infectious diseases programs; the
ability to expedite
development timelines by leveraging SwRI's
existing
Cepharanthine
preclinical
data sets and manufacturing know-how; the
ability to advance clinical
development of an improved oral formulation of Cepharanthine to
treat rare cancers and infectious
diseases; the ability to obtain applicable approval for the use of
Cepharanthine to treat esophageal cancer; the timing and
potential results of the Company's plan to initiate
high throughput studies to screen a large panel of additional
cancers; the
Company's plans to evaluate the benefit
of its
novel oral
formulation of Cepharanthine in an animal model of SARS-CoV-2
infection and its
proposed discussions with regulators regarding same.
This
forward-looking information reflects the Company's current beliefs
and is based on information currently available to the Company and
on assumptions the Company believes are reasonable. These
assumptions include, but
are not limited to the ability
of the Company to successfully execute on its plans
for the Company and Sairiyo;
the ability
to complete the studies referenced herein nd
the results
thereto; the ability to obtain required regulatory approvals
and the
Company's continued response and ability to navigate the COVID-19
pandemic being consistent with, or better than, its ability and
response to date.
Forward-looking
information is subject to known and unknown risks, uncertainties
and other factors that may cause the actual results, level of
activity, performance or achievements of the Company to be
materially different from those expressed or implied by such
forward-looking information. Such risks and other factors may
include, but are not limited to: general business, economic,
competitive, political and social uncertainties; general capital
market conditions and market prices for securities; the actual
results of the Company's future operations; competition; changes in
legislation affecting the Company; the ability
to obtain and maintain required permits and approvals,
the timing
and availability of external financing on acceptable terms; lack of
qualified, skilled labour or loss of key individuals; risks related
to the COVID-19 pandemic including various recommendations, orders
and measures of governmental authorities to try to limit the
pandemic, including travel restrictions, border closures,
non-essential business closures, service disruptions, quarantines,
self-isolations, shelters-in-place and social distancing,
disruptions to markets, economic activity, financing, supply chains
and sales channels, and a deterioration of general economic
conditions; and a deterioration of financial markets that could
limit the Company's ability to obtain external financing.
A
description of additional risk factors that may cause actual
results to differ materially from forward-looking information can
be found in the Company's disclosure documents on the SEDAR website
at www.sedar.com.
Although the Company has attempted to identify important factors
that could cause actual results to differ materially from those
contained in forward-looking information, there may be other
factors that cause results not to be as anticipated, estimated or
intended. Accordingly, readers should not place undue reliance on
forward-looking information. Readers are cautioned that the
foregoing list of factors is not exhaustive. Readers are further
cautioned not to place undue reliance on forward-looking
information as there can be no assurance that the plans, intentions
or expectations upon which they are placed will occur. Such
information, although considered reasonable by management at the
time of preparation, may prove to be incorrect and actual results
may differ materially from those anticipated.
The
Company's securities have not been registered under the U.S.
Securities Act of 1933, as amended (the "U.S. Securities Act"), or
applicable state securities laws, and may not be offered or sold
to, or for the account or benefit of, persons in the United States
or "U.S. Persons", as such term is defined in Regulations under the
U.S. Securities Act, absent registration or an applicable exemption
from such registration requirements. This press release shall not
constitute an offer to sell or the solicitation of an offer to buy
nor shall there be any sale of the securities in the United States
or any jurisdiction in which such offer, solicitation or sale would
be unlawful.
Forward-looking
information contained in this press release is expressly qualified
by this cautionary statement. The forward-looking information
contained in this press release represents the expectations of the
Company as of the date of this press release and, accordingly, are
subject to change after such date. However, the Company expressly
disclaims any intention or obligation to update or revise any
forward-looking information, whether as a result of new
information, future events or otherwise, except as expressly
required by applicable securities law.
References:
1) Bailly C. Cepharanthine: An
update of its mode of action, pharmacological properties and
medical applications. Phytomedicine. 2019 Sep;62:152956. doi:
10.1016/j.phymed.2019.152956. Epub 2019 May 10. PMID: 31132753;
PMCID: PMC7126782.
2) Rogosnitzky M, Danks R.
Therapeutic potential of the biscoclaurine alkaloid, cepharanthine,
for a range of clinical conditions. Pharmacol Rep.
2011;63(2):337-47. doi: 10.1016/s1734-1140(11)70500-x. PMID:
21602589.
3) Ohashi H, Watashi K, Saso W,
Shionoya K, Iwanami S, Hirokawa T, Shirai T, Kanaya S, Ito Y, Kim
KS, Nomura T, Suzuki T, Nishioka K, Ando S, Ejima K, Koizumi Y,
Tanaka T, Aoki S, Kuramochi K, Suzuki T, Hashiguchi T, Maenaka K,
Matano T, Muramatsu M, Saijo M, Aihara K, Iwami S, Takeda M,
McKeating JA, Wakita T. Potential anti-COVID-19 agents,
cepharanthine and nelfinavir, and their usage for combination
treatment. iScience. 2021 Apr 23;24(4):102367. doi:
10.1016/j.isci.2021.102367. Epub 2021 Mar 26. PMID: 33817567;
PMCID: PMC7997640.
4) Chen CZ, Xu M, Pradhan M,
Gorshkov K, Petersen JD, Straus MR, Zhu W, Shinn P, Guo H, Shen M,
Klumpp-Thomas C, Michael SG, Zimmerberg J, Zheng W, Whittaker GR.
Identifying SARS-CoV-2 Entry Inhibitors through Drug Repurposing
Screens of SARS-S and MERS-S Pseudotyped Particles. ACS Pharmacol
Transl Sci. 2020 Oct 19;3(6):1165-1175. doi:
10.1021/acsptsci.0c00112. PMID: 33330839; PMCID:
PMC7586456.