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Oncology Pharma Expands Feasibility Studies and Data

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SAN FRANCISCO, CA / ACCESSWIRE / February 17, 2022 / Oncology Pharma Inc. (OTC PINK: ONPH) – Oncology Pharma, Inc. (“The Company”) wishes to expand on a previously announced press release that included formulation results and technology data licensed with NanoSmart Pharmaceuticals, Inc. demonstrating the characteristic of time release which is expected to improve the safety and localization profile of potential lead candidate formulations.

The active pharmaceutical ingredient, dactinomycin is an actinomycin antibiotic belonging to a class of polypeptide antitumor antibodies. It inhibits transcription by binding to DNA at the transcription initiation complex and preventing RNA chain elongation by RNA polymerase. Dactinomycin has been used alone and in combination with other drugs to treat a wide range of cancers. Specifically, it has demonstrated clinical benefit for the treatment of pediatric and adult sarcomas and is used regularly 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 tissue, the small particle size (diameter range of 100 nm to 400 nm) allows passive accumulation of the drug at tumor sites. Passive accumulation occurs because tumor-associated blood capillaries have enlarged “pores” between lining endothelial cells and nanoparticles are able to pass through these “leaky” capillaries and enter the interstitial fluid space within tumor mass. Additionally, conjugation to polyethylene glycol (PEG) prevents the nanoparticle from being recognized and detoxified by the liver.

Oncology Pharma, Inc. has authorized and funded the first feasibility studies to date for this technology from NanoSmart and intends to commercially develop, distribute and use this product and continue studies so that it can put this product to market with the goal of initially focusing on the pediatric market. The Company believes that the pediatric market is underserved and this gives Oncology Pharma a pioneering edge in this critical market and enables Oncology Pharma to be a strong player in this well-deserved market.

Described below are the results of the first studies we have discussed before:

  • Initial formulations
    • Tested for drug incorporation (visual): >95% drug incorporation.

  • 50% remaining after 3 hours (better than drug-free formulation).
  • However, the formulation showed aggregation after several days in 4ohC storage. This is not optimal for formal development, but more favorable solutions have been found with further testing.
  • Formulation of the A-1 series
    • Tested for drug incorporation (spectrophotometer – quantitative measurement) – 100% drug incorporated.

  • However, the formulation showed aggregation after several days in 4ohC storage.
  • Formulation of the A-2 series
    • The preparation showed overnight aggregation at 4ohC, could not be filtered through a 0.22 µm membrane filter.

  • Decided to switch to natural oil over hydrogenated oil to increase amount of drug incorporation and to reduce aggregation (natural oil seems to aggregate less than hydrogenated oil in storage).
  • Formulation series B-1 (natural oil)
  • Attempt to filter through a 0.22 µm filter. Filter clogged quickly, indicating heavy aggregation after formulation (prior to storage).
  • Formulation of the B-2 series
    • Dilution and minor modification of formulation B-1, modification and extrusion 10X.

  • 100% drug incorporation (visual).
  • Aggregation still visible during storage at 4 o’clockohC (approx. 50%) – still possible to filter through a 0.22um filter.
  • After further research, it appears that repeated extrusion can impart additional energy to the nanoemulsion causing the nanodroplets to clump together. Also, an ice bath was not used during this preparation, which may be a factor.
  • Formulation of the B-3 series
  • Formulation B-2 was extruded 3x through 400/200/100 nm membranes at room temperature.
  • Formulation B-3 filtered through a 0.22 µm filter without clogging (see photo next slide).
  • Increasing the amount of glycerol added to Formulation B-3 did not improve the formulation.
  • 37-day drug release studyohVS :
    • 70% remaining after 1 hour, 35% remaining after 3 hours, 5% remaining after 6 hours. It is desirable to improve on this, but it is achievable as a sustained release formulation.
    • Submit split samples for physical characterization and initial analytical method validation.

The proprietary nanoemulsion under development also has the new potential to be stable during storage for an extended period. This contrasts with most lipid nanoparticle formulations which typically have a very short shelf life once formulated. The nanoemulsion formulation can likely be used for a wide range of lipophilic (i.e. non-water soluble) cancer drugs, thereby expanding the potential for licensing additional drug formulations using this same platform technology. -form, with each new drug being safer and more effective than the underlying drug formulation currently on the market.

Progress continues to be made on feasibility testing and initial data collection of nanoemulsion formulations for dactinomycin. Early work continues to show promise with formulations demonstrating a satisfactory level of nanoemulsion loading and dactinomycin retention. Studies to assess the physical characterization of the formulations, as well as quantitative performance measures (eg storage stability, release time, etc.) are ongoing.

ABOUT ONCOLOGY PHARMA, INC.

ONCOLOGY PHARMA, INC. (OTC PINK: ONPH) (the “Company”) is currently engaged in the research and development of therapies for oncology and prides itself on having a world-class advisory board that keeps the Company at the forefront of technology development in cancer research, biotechnology and healthcare.

ABOUT NANOSMART PHARMACEUTICALS, INC.

NanoSmart® Pharmaceuticals is a California-based private company that develops nanoparticle-based drug delivery platforms, including the use of antinuclear antibodies (ANA) to enable targeted drug delivery of existing drug therapies to areas of necrosis present in virtually all solid cancerous tumors.

FORWARD-LOOKING STATEMENTS

Certain of the matters discussed in this announcement contain forward-looking statements that involve significant risks and uncertainties in the Company’s business that may cause actual results to differ materially from those anticipated by the statements made herein. These risks and uncertainties include risks relating to licensing agreements and joint ventures, including the need to negotiate definitive agreements for the relationship; the possible inability to realize the expected benefits of business relationships and the costs of financing such business relationships. Other risks and uncertainties related to the Company include, among others, current negative operating cash flow and a need for additional financing to fund our operating plan; the terms of any other financing, which may be highly dilutive and may include onerous terms; unexpected operating costs and deficits, and lower-than-expected sales and revenues; the uncertain willingness and ability of customers to adopt new technologies and other factors that may affect future market acceptance; unfavorable economic conditions; adverse results of any legal proceedings; the volatility of our operating results and financial condition; failure to attract or retain qualified senior management, 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 potentially license to others patents and patent applications necessary to develop products; the Company’s ability to implement its long-term business plan for various applications of its technology; the Company’s ability to enter into agreements with all necessary marketing and/or distribution partners and with all strategic or joint venture partners; the impact of competition; obtaining and maintaining all necessary regulatory approvals applicable to applications of the Company’s technology; growth management; and, other risks and uncertainties. It is not a solicitation to buy or sell securities and does not purport to be an analysis of the financial condition of the Company.

CONTACTS:

For more information, please contact Oncology Pharma at:

One Sansome Street, Suite 3500
San Francisco, California 94104
Phone: 415-869-1038
Fax: 415-946-8801
website: www.oncologie-pharma.com
email: [email protected]

THE SOURCE: Oncology Pharma Inc.

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