May 26 2009
Aphios Corporation, a biotechnology company that is developing enabling technology platforms including nanotechnology drug delivery platforms such as phospholipid nanosomes, biodegradable polymer nanospheres, and protein and crystal nanoparticles for the improved delivery and targeting of poorly water-soluble anticancer drugs, therapeutic proteins and siRNA molecules, today announced that the results of a Phase II/III clinical trial of Zindol® for cancer chemotherapy induced nausea will be presented at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO) being held from May 29 to June 02, 2009 in Orlando, FL. Zindol® is an enhanced ginger product.
Despite the widespread use of the 5-HT3 receptor antagonist antiemetics, post-chemotherapy nausea and vomiting continue 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. A desirable attribute in any substitute or additional antiemetic medication is 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 shogaols. 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®. 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 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 side effects in this study, but patients should consult with their physicians before use.
The results of the clinical trial study entitled "Ginger for chemotherapy-related nausea in cancer patients: A URCC CCOP randomized, double-blind, placebo-controlled clinical trial of 644 cancer patients," will be orally presented and discussed on Saturday, May 30, 2009 from 1:00 to 4:00 p.m. in the Patient and Survivor Care session (Level 2, West Hall F5) of ASCO, Orlando, FL.