Oncology Pharma Releases Further Feasibility Studies, Data and Capacities
Oncology Pharma Inc. (OTC PINK:ONPH) announced progress on studies under its Co-Development Agreement with NanoSmart Pharmaceuticals, focusing on enhancing safety and localization of dactinomycin formulations for cancer treatment. The B-3 formulation lacks large aggregates and is suitable for characterization studies. The company explores pediatric cancer applications, aiming for FDA approval post-Phase II trials. It also highlights a multidrug nanoemulsion platform for improved treatment efficacy. Oncology Pharma targets the underserved pediatric market, enhancing its competitive position.
- Advancements in B-3 formulation showing no visible aggregates, suitable for further studies.
- Potential FDA New Drug Application after successful Phase II trials.
- Exploring multiple pediatric cancer treatment applications.
- Development of a multidrug nanoemulsion delivery platform with enhanced safety and efficacy.
- Current negative operating cash flows necessitating additional funding.
- Potentially onerous terms of future financing could dilute shareholder value.
- Risks associated with licensing arrangements and joint ventures that may not yield anticipated benefits.
SAN FRANCISCO, CA / ACCESSWIRE / February 23, 2022 / Oncology Pharma Inc. (OTC PINK:ONPH) - Oncology Pharma, Inc. ("The Company") looks toward releasing further results of the studies under the Co-Development Agreement with NanoSmart Pharmaceuticals, demonstrating the feasibility and 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.
Our B-3 Formulation:
- Examination of 0.22 um filter post-filtration of B-3 formulation.
- No visible residue on filter indicates no large aggregates in formulation.
Likely all particle sizes are < 200 um - deemed suitable for proceeding to physical characterization studies.
- Adaptive Design to assess multiple pediatric cancers with superior study statistical powering.
- Allows enrichment of promising populations after interim analysis (i.e., mid-study ‘peeks' at the data).
- Enables potential for multiple pediatric indications for use.
- Can approach FDA with New Drug Application as early as after successful Phase II clinical study.
- Exploring simultaneous evaluation for European market (EMA pediatric approvals).
Multidrug Nanoemulsion Potential::
In addition, this proprietary nanoemulsion drug delivery platform has the capacity to incorporate two different drugs within the same nanoemulsion. Each drug is selected to target a different phase in the cell cycle of the tumor cell and thus increase cytotoxicity to the tumor while still having a better safety profile than the predicate free drugs. Oncology Pharma will continue to advance initial development work and nonclinical studies on its lead formulation(s), while exploring additional opportunities utilizing this nanoemulsion platform delivery system. Combination drug formulations have the potential to provide for very significant advantages over existing chemotherapy regimens, making such formulations high valuation opportunities.
Oncology Pharma 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 under-served market.
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.
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