SAN
FRANCISCO, CA -- February 17, 2022 -- InvestorsHub NewsWire
-- Oncology Pharma Inc. (OTC PINK:ONPH) - Oncology Pharma, Inc. ("The
Company") wants to expand on a previously announced press release
that included results of formulations and data on licensed
technology with NanoSmart Pharmaceuticals demonstrating the time
release characteristic that is expected to improve the safety and
localization profile of the eventual lead candidate
formulations.
The active pharmaceutical ingredient,
dactinomycin is an actinomycin antibiotic belonging to a class of
polypeptide antitumor antibody. It inhibits transcription by binding to
DNA at the transcription initiation complex and preventing
elongation of RNA chain by RNA polymerase. Dactinomycin has been
used both alone and in combination with other drug products to
treat a wide range of cancers. Specifically, it has demonstrated
clinical benefit for the treatment of pediatric and adult sarcomas
and is used routinely as part of standard treatment regimens in
clinical practice for the treatment of Ewing's Sarcoma.
The benefits of lipid nanoparticle drug
delivery are well understood. In addition to sequestering toxic drugs
from healthy tissues, the small particle size (100 nm – 400 nm
diameter range) enables passive accumulation of the drug at the
tumor sites. Passive accumulation occurs because blood
capillaries associated with tumors have enlarged "pores" between
the lining endothelial cells and nanoparticles are able to pass
through these "leaky" capillaries and enter the interstitial fluid
space within the tumor mass. Additionally, conjugation to polyethylene
glycol (PEG) protects the nanoparticle from being recognized and
detoxified by the liver.
Oncology
Pharma, Inc. has licensed and has financed the early feasibility
studies to date for this technology from NanoSmart and intends on
commercially developing, distributing and utilizing this product
and continuing the studies so that it can jointly bring this
product to market with the target of initially focusing on the
pediatric market. The Company believes the
pediatric market is under-served and it gives an edge to Oncology
Pharma as a pioneer in this critical market and allows Oncology
Pharma to be a significant participant in this well deserved
market.
Described
below are the results of the early studies we addressed
before:
Initial
Formulations
•
Tested for drug incorporation
(visual): > 95% drug incorporation.
•
50% remaining after 3 hours
(better than free-drug formulation).
•
However, formulation had
aggregation after several days in 4oC
storage. This is not optimal for formal development, but more
favorable solutions were found with further testing.
Series A-1
Formulation
•
Tested for drug incorporation
(spectrophotometer – quantitative measurement) – 100% drug
incorporated.
•
However, formulation had
aggregation after several days in 4oC
storage.
Series A-2
Formulation
•
Preparation showed
aggregation overnight at 4oC,
could not be filtered through 0.22 um membrane filter.
•
Decided to switch to natural
vs. hydrogenated oil to increase amount of drug incorporation and
to reduce aggregation (natural oil appears to aggregate less than
hydrogenated in storage).
•
Series B-1 Formulation
(natural oil)
•
Attempted to filter through
0.22 um filter. Filter clogged quickly, indicating significant
aggregation after formulation (prior to storage).
Series B-2
Formulation
•
Dilution and minor change to
B-1 formulation change and extrude 10X.
•
Showed 100% incorporation of
drug (visual).
•
Still visible aggregation
upon storage at
4oC
(approx. 50%) – still possible to filter through a 0.22 um
filter.
•
Upon additional research,
appears that repeated extrusion may impart additional energy to
nanoemulsion causing nanodroplets to aggregate. In addition, an ice
bath was not used during this prep which may be a
factor.
Series B-3
Formulation
•
B-2 formulation was extruded
3x through 400/200/100 nm membranes at room temperature.
•
B-3 formulation was possible
to filter trough 0.22 um filter without clogging
(see picture next
slide).
•
Increasing amount of glycerol
added to B-3 formulation did not improve formulation.
•
Drug release study conducted
at 37oC:
70% remaining after 1 hour,
35% remaining after 3 hours, 5% remaining after 6 hours. Improving
upon this is desirable, but this is workable as a time-release
formulation.
•
Submitting split samples for
physical characterization and initial analytical method
validation.
The proprietary nanoemulsion being
developed also has the novel potential to be stable during storage
for an extended period of time. This is in contrast to most lipid
nanoparticle formulations that typically have a very short
shelf-life once formulated. The nanoemulsion formulation can likely
be utilized for a broad range of cancer drugs that are lipophilic
(i.e. not water soluble), thus expanding the potential to license
additional drug formulations utilizing this same platform
technology, with each novel drug being safer and more effective
than the predicate drug formulation currently on the
market.
Advancement
continues to be made on the feasibility testing and initial
gathering of data of nanoemulsion formulations for
dactinomycin. Early
work continues to be promising with formulations demonstrating a
satisfactory level of nanoemulsion loading and retention of
dactinomycin. Studies
to assess the physical characterization of the formulations, as
well as quantitative performance measures (e.g., storage stability,
time-to-release, etc.) are underway.
ABOUT
ONCOLOGY PHARMA, INC.
ONCOLOGY
PHARMA, INC. (OTC PINK: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.
ABOUT
NANOSMART PHARMACEUTICALS, INC.
NanoSmart®
Pharmaceuticals is a privately-held California corporation that is
developing nanoparticle drug delivery platforms, including
utilization of anti-nuclear antibody (ANA) to enable targeted drug
delivery of existing drug therapies to areas of necrosis present in
virtually all solid cancer tumors.
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
SOURCE: Oncology
Pharma Inc.