Synthesis of Critical Chemical Intermediate for Drug Confirmed
NEW YORK, Oct. 28, 2020 /PRNewswire/ -- AIkido Pharma Inc. (Nasdaq: AIKI) ("AIkido" or the "Company") today provided an update on its preclinical work on its next-generation chemotherapeutic, DHA-dFdC, and the solid lipid nanoparticle (SLN) drug delivery system to treat pancreatic cancer, which the Company has licensed from the University of Texas at Austin.
Pancreatic cancer is the 4th leading cause of cancer deaths in the US and, partly because most cases are diagnosed at an advanced stage, the 5-year overall survival rate for those cases has remained only around 3%. See Sci Rep 10, 7048 (2020). The Company is developing its drug product as an orally administered second-line treatment to target advanced pancreatic cancer.
The Company confirmed this week the successful synthesis of a critical intermediate compound for DHA-dFdC. Purification and isolation of this key intermediate were also completed and verified. The Company is also in the process of optimizing the SLN delivery vehicle with respect to particle size and stability.
In addition, the Company recently expanded upon its agreement with Parimer Scientific to immediately begin manufacturing activities including the following:
Developing analytical methods for both raw materials and final drug product,
Producing an optimized process for batch scale-up of the drug,
Producing and delivering 20,000 mg of final drug product to be used in toxicology studies,
Performing initial short-term and long-term stability testing in the selected bulk container closure using ICH Q1A(R2) Stability Testing of New Drug Substances and Products,
Creating a drug substance reference standard, and
Establishing drug purity per the relevant FDA standards.
Under the expanded agreement, the final drug product will be manufactured using at minimum GLP practices per 21 CFR 58 and following the recommendations in the FDA's ICH Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.
Dr. Richard T. Pace, Principal Scientist at Parimer Scientific commented, "We are very gratified to have confirmed isolation of the crucial chemical intermediate for this drug. These results strongly indicate that developing a scalable process for drug manufacture will be achievable."
Anthony Hayes, CEO of AIkido stated, "These are the results we have been hoping for and they greatly increase my optimism about the scalability of this product. We plan to rapidly develop the process of drug incorporation into the SLN delivery particles and start preliminary biological testing, which should begin this quarter."
About AIkido Pharma Inc.
AIkido Pharma Inc. was initially formed in 1967 and is a biotechnology company with a diverse portfolio of small-molecule anti-cancer therapeutics. The Company's platform consists of patented technology from leading universities and researchers and we are currently in the process of developing an innovative therapeutic drug platform through strong partnerships with world renowned educational institutions, including The University of Texas at Austin and Wake Forest University. Our diverse pipeline of therapeutics includes therapies for pancreatic cancer, acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). In addition, we are constantly seeking to grow our pipeline to treat unmet medical needs in oncology.
Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Company's filings with the SEC, not limited to Risk Factors relating to its business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.
Brett Maas, Managing Partner
Phone: (646) 536-7331
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SOURCE AIkido Pharma Inc.