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 - 05:17AM
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.
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