The development of Zindol®, an enhanced ginger product, through a multi-center clinical trial will be orally presented and discussed on Wednesday, October 26, 2011 from 8:30 to 11:00 am EST in the Symposium on "Evaluating Drug Development Opportunities in Botanical Polymolecular Therapeutics" at the AAPS 2011 Meeting and Exposition.
Despite the widespread use of the 5-HT3 receptor antagonist anti-emetics, CINV continues to be reported by up to 70% of patients receiving chemotherapy. Furthermore, these antiemetics have been associated with significant adverse effects, such as sedation, extra-pyramidal side effects and hypotension (associated with dopamine antagonists), as well as headache, diarrhea or constipation. Desirable attributes in any substitute or additional antiemetic medication are both efficacy and the absence of clinically significant adverse effects.
"Zindol® is an enhanced ginger product that is standardized by the bioactive constituents of ginger, gingerols and shogaol," explains Dr. Castor.
"Aphios' scientists and engineers utilized a proprietary polarity-guided SuperFluids™ CXF fractionation technology to establish conditions for the isolation of the active ingredients of Zindol®," he continued. "The technology was then scaled-up for producing large quantities of the active ingredients utilizing patented SuperFluids™ CXP manufacturing technologies."
The enhanced ginger concentrate was then formulated to achieve a specific concentration of ginger bioactives with all-natural liquid excipients designed to maximize stability and bioavailability of bioactive constituents, and encapsulated in gel capsules (LiCaps™) by Capsugel, Inc., a former Pfizer subsidiary.
Researchers at the University of Rochester Medical School conducted a multi-site, Phase II/III randomized, placebo-controlled, double-blind clinical trial to assess the efficacy of Zindol® (ginger capsules) for chemotherapy-related nausea in 644 cancer patients. Cancer patients who experienced nausea were randomized into four arms: placebo and 3 dose-escalation arms taking ginger capsules equivalent to 0.5, 1.0 and 1.5 grams ginger. All patients received 5-HT3 receptor antagonist antiemetics on Day 1 of all cycles. Data from the clinical trial indicates that all ginger doses significantly reduced nausea with the middle and lowest doses giving the best results. Ginger caused no serious side effects in this study.
Aphios® Corporation is a green biotechnology company developing enabling technology platforms for improved drug discovery and manufacturing, nanotechnology drug delivery and pathogenic drug safety. Based on these platforms, Aphios® is developing enhanced therapeutic products for health maintenance, disease prevention and the treatment of certain cancers, infectious diseases such as HIV and influenza, and central nervous system disorders such as Alzheimer's Disease.