Adial Pharmaceuticals Announces Positive Pre-Clinical Data for PNV2 as a Drug Candidate for Triple Negative Breast Cancer
30 November 2021 - 1:00AM
Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW)
(“Adial” or the “Company”), a clinical-stage biopharmaceutical
company focused on developing therapies for the treatment and
prevention of addiction and related disorders, today announced
positive pre-clinical data for PNV2 in an animal model of triple
negative breast cancer (TNBC). Based on the strength of this data,
Purnovate, Inc., a wholly owned subsidiary of Adial
Pharmaceuticals, Inc., plans to advance PNV2 as the lead compound
for its cancer program.
PNV2 was tested in a metastatic breast cancer
model with the primary endpoint being the amount of cancer
metastases into the lungs after 28 days following orthotopic
implantation of breast cancer.
Study highlights:
- Luciferase-engineered triple-negative breast cancer (TNBC)
cells MDA-MB-231 were implanted in the mammary fat pad in female
mice.
- Tumors grew over 28 days and were treated intratumorally three
times a week.
- An active group (n=10) was treated with PNV2 in solution and a
control group (n=10) was treated with only the solution.
- Metastasis into the lungs was then determined by measuring the
amount of luciferase activity, which indicates the amount of cancer
in the lungs.
- In the control group, 30% of the mice had large,
well-established secondary tumors (i.e., metastatic, invasive
tumors) in their lungs with luciferase activity of greater than
1585 AU in each mouse, while the PNV2 group appeared to have no
large secondary tumors in the lungs of any mouse and luciferase
activity of not more than 356 AU in any mouse.
Dr. Julien Dimastromatteo, Purnovate’s Vice
President, Research, commented, “This pre-clinical data is
encouraging, as we seem to have demonstrated a reduction in
metastases and cancer invasion into the lungs following treatment
with PNV2. This data confirms prior research on the anti-cancer
properties of adenosine analogs. However, historically, the
solubility of these compounds has been a barrier to developing an
effective therapy. This latest research around PNV2 is particularly
exciting as we believe we have overcome the solubility challenges.
We plan to conduct additional pre-clinical research with a goal of
advancing PNV2 into clinical trials in 2022.”
William Stilley, Adial’s Chief Executive
Officer, stated, “The Purnovate adenosine platform continues to
demonstrate broad potential across a wide range of indications and
is exceeding expectations. We are especially encouraged by this
latest data in triple negative breast cancer following the recent
pain data. We look forward to aggressively pursuing the full
potential of the Purnovate Adenosine Platform and are evaluating
the best strategy to achieve full value for our shareholders from
the Platform, while we remain laser focused at Adial on obtaining
our Phase 3 data on AD04 for treatment of Alcohol Use
Disorder.”
PNV2 has been tested to be more than 1000-fold
selective over the adenosine A1 receptor, which is known to have
cardiovascular and central nervous system effects that have limited
the usefulness of adenosine analogs as treatments. Historically,
when selectivity has been achieved over the A1 receptor, water
solubility has decreased, making effective tissue distribution in
the human body (made largely of water) difficult to achieve.
However, PNV2 has demonstrated solubility more than 50 times
greater than other known selective adenosine compounds of the same
class. Solubility is often an important characteristic of
successful drug candidates, and Purnovate believes solubility is a
particularly important characteristic in determining the drug
development potential of molecules of this class.
About Purnovate, Inc.
Purnovate, Inc., a wholly owned subsidiary of
Adial Pharmaceuticals, Inc., is a pharmaceutical development and
chemistry company focused on inventing and developing selective,
potent, stable, and soluble adenosine analogs to treat diseases and
disorders such as pain, cocaine addiction, inflammation, infectious
disease, cancer, asthma, and diabetes. Additional information is
available at www.purnovate.com.
About Adial Pharmaceuticals,
Inc.
Adial Pharmaceuticals is a clinical-stage
biopharmaceutical company focused on the development of treatments
for addictions. The Company’s lead investigational new drug
product, AD04, is a genetically targeted, serotonin-3 receptor
antagonist, therapeutic agent for the treatment of Alcohol Use
Disorder (AUD) and is currently being investigated in the Company’s
landmark ONWARD™ pivotal Phase 3 clinical trial for the potential
treatment of AUD in subjects with certain target genotypes, which
are to be identified using the Company’s proprietary companion
diagnostic genetic test. A Phase 2b clinical trial of AD04 for the
treatment of AUD showed promising results in reducing frequency of
drinking, quantity of drinking and heavy drinking (all with
statistical significance), and no overt safety concerns (there were
no statistically significant serious adverse events reported). AD04
is also believed to have the potential to treat other addictive
disorders such as Opioid Use Disorder, gambling, and obesity. The
Company is also developing adenosine analogs for the treatment of
pain and other disorders. Additional information is available at
www.adialpharma.com.
Forward Looking Statements
This communication contains certain
"forward-looking statements" within the meaning of the U.S. federal
securities laws. Such statements are based upon various facts and
derived utilizing numerous important assumptions and are subject to
known and unknown risks, uncertainties and other factors that may
cause actual results, performance or achievements to be materially
different from any future results, performance or achievements
expressed or implied by such forward-looking statements. Statements
preceded by, followed by or that otherwise include the words
"believes," "expects," "anticipates," "intends," "projects,"
"estimates," "plans" and similar expressions or future or
conditional verbs such as "will," "should," "would," "may" and
"could" are generally forward-looking in nature and not historical
facts, although not all forward-looking statements include the
foregoing. The forward-looking statements include statements
regarding plans to advance PNV2 as the lead compound for our cancer
program, having overcome the solubility challenges of selective
adenosine compounds and solubility being a particularly important
characteristic in determining the drug development potential of
molecules of this class, plans to conduct additional pre-clinical
research with a goal of advancing PNV2 into clinical trials in
2022, aggressively pursuing the full potential of the Purnovate
Adenosine Platform and the potential of AD04 to treat other
addictive disorders such as Alcohol Use Disorder, Opioid Use
Disorder, gambling, and obesity. Any forward-looking statements
included herein reflect our current views, and they involve certain
risks and uncertainties, including, among others, our ability to
advance PNV2 into clinical trials and achieve similar results as
those achieved in preclinical studies, our ability to commence
clinical trials of PNV2 in 2022, our ability to enroll patients
within the timelines anticipated and complete clinical trials on
time and achieve desired results and benefits as expected, our
ability to obtain regulatory approvals for commercialization of
product candidates or to comply with ongoing regulatory
requirements, regulatory limitations relating to our ability to
promote or commercialize our product candidates for specific
indications, acceptance of our product candidates in the
marketplace and the successful development, marketing or sale of
our products, our ability to maintain our license agreements, the
continued maintenance and growth of our patent estate, our ability
to establish and maintain collaborations, our ability to obtain or
maintain the capital or grants necessary to fund our research and
development activities, and our ability to retain our key employees
or maintain our Nasdaq listing. These risks should not be construed
as exhaustive and should be read together with the other cautionary
statement included in our Annual Report on Form 10-K for the year
ended December 31, 2020, subsequent Quarterly Reports on Form 10-Q
and current reports on Form 8-K filed with the Securities and
Exchange Commission. Any forward-looking statement speaks only as
of the date on which it was initially made. We undertake no
obligation to publicly update or revise any forward-looking
statement, whether as a result of new information, future events,
changed circumstances or otherwise, unless required by law.
Contact:Crescendo Communications,
LLC David
Waldman / Natalya
Rudman Tel:
212-671-1021 Email:
adil@crescendo-ir.com
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