Aphios Corporation, a longtime leader in the development of novel botanical pharmaceuticals and nutraceuticals, announced today that it has been awarded a Small Business Innovation Research (SBIR) Phase I grant from the National Center for Complementary & Integrative Health (NCCIH) of the National Institutes of Health (NIH). The grant assures’ Aphios’ continuing ability to advance the development of Zindol®, a novel botanical drug candidate derived from ginger for the treatment of chemotherapy-induced nausea and vomiting (CINV).

CINV remains one of the most common and most distressing side effects of cancer treatment, impacting up to 70% of adult patients receiving highly anti-nausea emetogenic chemotherapy drugs. Despite the availability of pharmaceutical 5-HT3 and NK-1 receptor antagonists, a significant number of patients continue to suffer profound, debilitating side effects, leading to a large number of patients refusing subsequent chemotherapy cycles. The consequences of these patient choices can be life-threatening.

Zindol® is a highly purified, standardized botanical drug derived from ginger that has been developed using Aphios’ patented SuperFluids™ extraction technology. Prior clinical studies of an earlier, patented dietary supplement formulation (Zindol® DS, ~30% purity) in more than 600 cancer patients demonstrated a highly significant reduction of nausea (p=0.003) and improved efficacy over Zofran® (Ondansetron) without adverse side effects. Zindol® DS has also shown efficacy in motion and morning sickness as well as nausea and vomiting associated with surgery and medications such as anti-obesity GLP-1 agonists and other drugs. It has also been used effectively by women during pregnancy. This most current in a long series of NIH awards will enable Aphios to develop a next-generation formulation of Zindol® (>90% purity of gingerols and shogaol, the proven bioactives), establish product stability and release criteria, and evaluate its activity in an innovative in vitro nausea assay.

“We are honored to receive this highly competitive NIH award at this time. It validates the near term and long term promise of Zindol® as a safer and more effective solution for patients undergoing chemotherapy and treatments for obesity,” said Dr. Trevor P. Castor PhD, President, Founder & CEO of Aphios Corporation and Principal Investigator of the project. He then added, “This most recent NIH support allows us to advance Zindol® toward clinical trials and ultimately provide cancer and obesity patients with a safe, effective and much-needed therapeutic option derived exclusively from a common food spice.”

If successful as anticipated based on prior research, Zindol® could eliminate the need for combinations of synthetic antiemetics, reduce treatment costs, and dramatically improve quality of life for millions of current and future cancer and obesity patients worldwide. Aphios plans to pursue Phase II IND-enabling toxicology studies and future Phase III clinical trials, with the goal of licensing the botanical drug to a strategic pharmaceutical partner to address the rapidly growing $3.4 billion antiemetics market that currently lacks a similar alternative.

About Aphios Corporation: Aphios Corporation is a biopharmaceutical company with over 25 years of developing green, enabling technology platforms for improving the discovery, development, and delivery of therapeutic products. With more than 85 issued patents, Aphios focuses on unmet medical needs in oncology, infectious disease, CNS disorders, and other major health challenges, as well as everyday quality of life challenges.

Funding Acknowledgment: Research reported in this press release is being supported by the National Center for Complementary & Integrative Health (NCCIH) of the National Institutes of Health (NIH) under Award Number R43AT013554. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

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CINV remains one of the most common and most distressing side effects of cancer treatment, impacting up to 70% of adult patients receiving highly anti-nausea emetogenic chemotherapy drugs.