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AIkido Pharma Inc. Provides Update on Its Next-Generation Chemotherapeutic Treatment DHA-dFdC

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AIkido Pharma Inc. (Nasdaq: AIKI) announced progress on its next-generation chemotherapy drug DHA-dFdC, targeting pancreatic cancer. The company has successfully synthesized a key intermediate compound and is optimizing its solid lipid nanoparticle (SLN) delivery system. A new agreement with Parimer Scientific includes developing analytical methods and manufacturing processes for the drug. The 5-year survival rate for pancreatic cancer remains around 3%, underscoring the need for innovative treatments. The company aims to initiate preliminary biological testing soon.

Positive
  • Successful synthesis of a critical intermediate compound for DHA-dFdC.
  • Optimizing the solid lipid nanoparticle (SLN) drug delivery system.
  • Expanded agreement with Parimer Scientific to enhance manufacturing processes.
Negative
  • None.

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.

Forward-Looking Statements

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.

Contact:




Investor Relations:     



Hayden IR


Brett Maas, Managing Partner


Phone: (646) 536-7331


Email: brett@haydenir.com


www.haydenir.com



AIkido: 



Phone: 212-745-1373


Email: investorrelations@aikidopharma.com


www.aikidopharma.com





        

 

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SOURCE AIkido Pharma Inc.

FAQ

What progress has AIkido Pharma made on DHA-dFdC for pancreatic cancer?

AIkido Pharma confirmed the successful synthesis of a key intermediate compound for DHA-dFdC and is optimizing the SLN delivery system.

What is the significance of DHA-dFdC in treating pancreatic cancer?

DHA-dFdC represents a new second-line treatment option for advanced pancreatic cancer, which has a low survival rate.

What are the next steps for AIkido Pharma regarding its new drug?

The company plans to rapidly develop the drug incorporation process into the SLN particles and start preliminary biological testing.

What does the agreement with Parimer Scientific entail?

The agreement includes developing analytical methods, producing a batch scale-up process, and conducting stability testing for the drug.

What is the current status of pancreatic cancer treatment options?

The 5-year overall survival rate for pancreatic cancer remains around 3%, highlighting the need for effective new therapies.

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