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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
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.
About this update from Oncology Pharma Inc.
[{"type":"text","content":"SAN FRANCISCO, CA / ACCESSWIRE / September 13, 2021 / 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. (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.FORWARD LOOKING STATEMENTSCertain of the matters discuss...