Oncology Pharma Announces: Initial Feasibility Study of the Nanoemulsion Drug Delivery System is Complete and Results Have Met the Threshold for Moving Forward To the Next Steps of Development
June 08 2022 - 8:17AM
InvestorsHub NewsWire
Oncology Pharma Announces: Initial Feasibility
Study of the Nanoemulsion Drug Delivery System is Complete and
Results Have Met the Threshold for Moving Forward To the Next Steps
of Development
SAN FRANCISCO, CA -- June 8, 2022 -- InvestorsHub NewsWire --
Oncology Pharma Inc. (OTC PINK: ONPH) - Oncology Pharma, Inc. ("The
Company") is pleased that the initial feasibility stage is complete
and results have met the threshold to move forward.
The formulation under development consisted of the active
pharmaceutical ingredient (dactinomycin) encapsulated in a
saturated lipid and combined with various emulsifiers, surfactants,
and stabilizers. The specific identity and ratios of these
ingredients, along with the processing methods and processing
parameters utilized, lead to formulations with very different
characteristics. Various qualitative assessments (described in the
previous section) were performed on the various iterations of the
formulations and included:
- Test for drug incorporation
- Test for release over time
The most promising formulation candidates (i.e., those which
demonstrated acceptable feasibility using qualitative assessments)
were forwarded to an analytical laboratory for initial
characterization, which included:
- Test for physical properties
- Tests for formulation drug concentration
During the feasibility stage of this project, the Company sought
to acquire research and development equipment, establish an
early-phase formulation laboratory, verify the capability of
developing lipid nanoemulsions, and identify some promising
formulations for further development. All goals were successfully
accomplished. The data provided a high-level overview of the
various formulations that were created and evaluated during this
feasibility stage.
Essentially, all of the specific aims under the scope of this
project were met. The capability to formulate nanoemulsions that
incorporate the active pharmaceutical ingredient, dactinomycin, was
demonstrated. Specifically, the Company identified two formulations
feasible for further development based on the following:
- The nanoparticle size was approximately 200 nm, which would
improve drug delivery at the tumor site.
- The nanoparticles did not aggregate during storage at 40 C,
which enables commercial viability.
- Dactinomycin incorporation in the nanoparticles was
approximately 100%
- Drug release-over-time study showed about 50% of the drug is
retained at 3 hrs.
- There is 1 mg dactinomycin in 4 ml of nanoemulsion, which is
within the range of standard dose administration.
The capability to be able to innovate and make progress in this
early stage demonstrates the Company's ability to identify
developmental goals and overcome formulation challenges to produce
a drug formulation with suitable characteristics for further,
formal nonclinical development. These characteristics include the
ability for the nanoemulsion to incorporate the majority of
available drug into the lipid nanoparticles, a demonstrated
release-over-time profile, and stability during storage.
Additionally, test methods were established at independent contract
laboratories to support basic formulation characterization and
accurately detecting the drug concentration in control and test
formulations in support of future nonclinical studies.
Oncology Pharma is committed to finding the path to further
development of our licensed technologies and developing the
financial model to see this through to the next phases. The Company
is reviewing feasibility of some initial applications to the FDA
that could enhance the development process.
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
Oncology Pharma (CE) (USOTC:ONPH)
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