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 / ACCESSWIRE / June 8, 2022 / 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.
For additional Information, please contact the Oncology Pharma at:
SOURCE: Oncology Pharma Inc.
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