Oncology Pharma, Inc. Has Received the Committed Funding to Perform All Necessary IND-Enabling Preclinical Work for Its First Lead Candidate, a Dactinomycin Nanoemulsion Drug Product
13 Septembre 2021 - 2:30PM
InvestorsHub NewsWire
September
13, 2021 -- InvestorsHub NewsWire -- Oncology Pharma, Inc.
(OTC
PINK:ONPH). In keeping with
management’s commitment to continue implementation of Oncology
Pharma’s (“the Company”) capital formation plan, the Company has
obtained, received and segregated all funds necessary to execute
the first phase of the development project of a nanoemulsion of
dactinomycin, with the initial tranche released as
scheduled.
Management
of Oncology Pharma felt it was important to select an experienced
team for this process. We are confident in the team that is
conducting this initial phase, as they have vast experience in drug
development. The team is made up of individuals that have a
specialty in biotech, pre-clinical development and regulatory
approval of numerous novel medical devices and pharmaceutical
products. They are experts in implementing highly effective
corporate culture and quality management infrastructure compliant
with US FDA and ISO regulations. The team has further
developed and implemented ISO (International Organization for
Standardization), GMP (Good Manufacturing Practices) and GLP (Good
Laboratory Practices) quality systems. Managed regulatory
applications for various medical product manufacturers (510(K), PMA
IND/IDE, etc.).
The primary
goal is to bring new pharmaceutical drug formulations to market
with a focused approach that aims to reduce overall costs and time
to commercialization. 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.
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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