Oncology
Pharma's Co-Development Agreement
Pursues Strategic and
Direct Objectives
August 23, 2021 --
InvestorsHub NewsWire -- Oncology Pharma, Inc. (OTC
PINK:ONPH) defines
its objective and
strategy for recently signed Co-Development deal. . The primary goal of the
Co-Development plan is to bring new pharmaceutical drug
formulations to market with a focused approach that aims to reduce
overall costs and minimize time and duration
to
commercialization.
Oncology Pharma is focusing
on rare childhood or
pediatric
cancers. Pediatric cancers are
traditionally underserved and very much in need of improved
therapies such as those being developed by Oncology
Pharma. The FDA provides an Orphan
Drug pathway to companies developing drugs targeted at rare
diseases, identified as those with less than 200,000 people in the
US. The Orphan Drug pathway
enables expedited review by the FDA and the potential for lower
number of patients needed in clinical studies.
Also, for
pediatric oncology products., there is a potential for
New Drug Approval after successful completion of Phase II clinical
studies, with Phase III data being able to be collected while in
the market. This incentive enables drug
companies to focus on rarer diseases and dramatically decreases the
potential costs and time to market approval. In order
to
encourageincentive
development
offor improved therapies for
these under-servedneeded rare
patient
populationss.Oncology
Pharma is focusing on pediatrics and non-clinical
studies. Pediatric medications
are
traditionally
underserved, and the FDA offers
opportunity
to facilitate
approval to get
to market efficiently. This market has a lower
barrier to entry and once the drug is shown to be safe and
effective, it can get to market quicker than if focused on
the adult human market and can be a
valuable steppingstone to leverage data and create an efficient
path. Non-clinical studies are
testing, which will be done that leads to an IND (Investigational
New Drug) result, moving the process
forward.
The
co-development project is for the development of
a dactinomycin
nanoemulsion
drug
product, a
targeted lipid nanoparticle formulation. Dactinomycin has been shown
to be effective in destroying cancer cells. However, the practical use of
the drug is very limited due to its high toxicity.
Encapsulating drugs
in lipid
nanoparticles
is known
to mitigate
toxicity and
is therefore
an excellent approach
to reformulate highly toxic
pharmaceutical substances.
Encapsulating tdactinomycin enables
the drug compounds enables
the localization
of the
drug at the
tumor site, which improves
the
safety and efficacy of
the the
dactinomycin.final
formulation. The nanoparticle that
encloses the API protects healthy tissues while traveling to its
target, and then slowly releases the drug over time. The end-result
is a superior safety and efficacy profile for any drug that is
adapted to our system.The nanoparticle that
encloses the APIdactinomycin
protects healthy
tissues while traveling to the tumorits target, and then slowly releases
the drug over time. Additionally, the nano-sized
particles "leak" through the blood vessels near the tumor and
localize the drug-filled nanoparticle at the tumor
site. HBy having the nanoemulsion particles release the medicine
slowly
over time
and at the tumor
site , enables the destruction of
the invading
cancer while minimizing negative effects on the rest of the
body.
Therefore, what wouldan otherwise be a toxic dose may be
administered more safely when delivered slowly over
time, so it focuses on destroying the
invading cancer while minimizing negative effects on the rest of
the body. . This approach provides
the potential to
give suitable
drug candidates a e
end-result is a superior safety and efficacy
profile. for any drug that is adapted
to our system.
There are a total of three
stages in the plan for which
fFunding
has been already been obtained and
and
committed to perform all necessary IND-enabling preclinical work
for the first lead candidate. , with and
incremental funds having been
funded,
and additional
funds that have been committed
andwhich are available
based on
performance. First stage
is
to generate an
overall plan, map out steps and procedures, which lays out what
needs to be utilized and how to move forward with
a timetable, assess costs, facilities,
groups to work with etc. The second stage involves
non-clinical trials and benchmark studies, which involves non-human
trials in a laboratory setting. Benchmarking is the
process of determining the best processes, strategies, and
techniques for achieving objectives. The final stage is
bringing the drug to market and commercialization.
There is an old saying that
"one man's medicine is another man's poison." This phrase teaches a
principle that toxicity is just a matter of dose and that with a
high enough exposure, even a normally beneficial substance can
become toxic at a high enough dose. Utilizing
a targeted
delivery system teaches the exact reverse of
this principle, namely that "one man's poison can be another man's
medicine." Once a drug can be shown to be
less toxic and safer through its Phase 1 trial,The first step
will
be to formulate an
existing FDA-approved active pharmaceutical ingredient
(dactinomycin) inside a nanoemulsion
formulation.
The
next step will
involve
assessing the lead drug formulation in nonclinical pharmacokinetic
and toxicokinetic safety studies. This is to determine if
the nanoemulsion
formulation is safer
than the free drug alone. With data accumulated
demonstrating a safer drug, the Investigational New Drug
application will be submitted to the US FDA, seeking
permission to move into human
clinical trials.
the FDA may allow drug
to go to market after Phase 2 trial, with no Phase 3
required.
Oncology Pharma's
Co-Development Agreement focuses on using dactinomycin nanoemulsion
drug product, intended for the treatment
of pediatric cancer. Utilizing the Nanoemulsion for the
targeted delivery system is expecting to allow a safe dose of the
drug to be delivered over time, so it may be safely
administered.
A modern-day
formulation that
incorporates a similar methodology idea of controlling and
limiting
the amounf
of a
substance to have something previously
labeled as toxic to something that may be used
safely would be Botox[JM1].
Botox is a drug made from a toxin produced by the bacterium
Clostridium botulinum. It's the same toxin that
causes a life-threatening type of food poisoning called
botulism. Doctors use it in small doses
to treat health problems and even clinics and spas are offering
Botox injections to eliminate facial wrinkles. In this case,
something that was otherwise toxic and deadly, is able to be
beneficially used when the amount present in the body is greatly
diminished, allowing for beneficial and effective
use.
Oncology Pharma has been
working very diligently to launch this initial
co-development project and is get this agreement
completed,
which has been accomplished, and is excited with the potential for
utilizing its licensed intellectual properties to help address a
virtually unmet
medical
need. with
the direction of the Ccompany. The first
stage of the plan has already begun and uUpdates will be made available
as news and data become relevant in the coming weeks and
months. .
ABOUT
ONCOLOGY PHARMA, INC.
ONCOLOGY PHARMA, INC.
(OTCPK:
ONPH) (the 'Company') is currently engaging in research and
development of therapeutics for oncology and prides itself for
having a world-class Advisory Board that keeps the Company in the
forefront of developing technologies in cancer research,
biotechnology, and healthcare.
FORWARD
LOOKING STATEMENTS
Certain of the
matters discussed in this announcement contain forward-looking
statements that involve material risks to and uncertainties in the
Company's business that may cause actual results to differ
materially from those anticipated by the statements made herein.
Such risks and uncertainties include risks related to licensing
arrangements and joint ventures, including the need to negotiate
the definitive agreements for the relationships; possible failure
to realize anticipated benefits of business relationships, and
costs of providing funding to these business relationships. Other
risks and uncertainties relating to the Company include, among
other things, current negative operating cash flows and a need for
additional funding to finance our operating plan; the terms of any
further financing, which may be highly dilutive and may include
onerous terms; unexpected costs and operating deficits, and lower
than expected sales and revenues; uncertain willingness and ability
of customers to adopt new technologies and other factors that may
affect further market acceptance; adverse economic conditions;
adverse results of any legal proceedings; the volatility of our
operating results and financial condition; inability to attract or
retain qualified senior management personnel, including sales and
marketing personnel; our ability to establish and maintain the
proprietary nature of our technology through the patent process, as
well as our ability to possibly license from others patents and
patent applications necessary to develop products; the Company's
ability to implement its long range business plan for various
applications of its technology; the Company's ability to enter into
agreements with any necessary marketing and/or distribution
partners and with any strategic or joint venture partners; the
impact of competition; the obtaining and maintenance of any
necessary regulatory clearances applicable to applications of the
Company's technology; management of growth; and, other risks and
uncertainties. This is not a solicitation to buy or sell securities
and does not purport to be an analysis of the Company's financial
position.
CONTACTS:
For additional
Information, please contact the Oncology Pharma at:
One Sansome Street,
Suite 3500
San
Francisco, CA 94104
Phone:
415-869-1038
Fax:
415-946-8801
website:
www.oncology-pharma.com
email:
info@oncology-pharma.com