Aphios Corporation

Zindol®

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 highly emetic chemotherapy agents, such as cisplatin, carboplatin and doxorubicin. 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 would be the absence of clinically significant adverse effects.

Since the 16th century, practitioners of both Indian (Ayurvedic) and traditional Chinese medicine (TCM) have used ginger (Zingiber officinale Roscoe) to treat gastro-intestinal upsets such as nausea and excessive flatulence. North American folklore also recognizes the ability of ginger to relieve gastrointestinal upsets including nausea. Ginger is believed to be the only herb that can prevent symptoms of motion sickness.

Ginger has been approved for that use by Germany’s Commission E, the agency responsible for regulating the use of herbal products in that country. Ginger has recently been studied scientifically for its effect on nausea and vomiting associated with motion sickness, surgery and pregnancy. Ginger is listed as a GRAS (generally regarded as safe) food by the U.S. FDA.

Zindol® is an enhanced ginger product that is standardized by the bioactive constituents, gingerols and shogaol, of ginger. Aphios’ scientists and engineers utilize polarity-guided Super-Fluids™ [SFS] CXF fractionation technology to establish conditions for the isolation of the active ingredients of Zindol® [US Patents 5,854,064; 6,569,640]. The technology is then scaled-up to manufacture the active pharmaceutical ingredients utilizing patented SFS-CXP manufacturing tech-nologies [US Patents 5,440,055; 5,750,709].

We use organically grown ginger and SuperFluids™ carbon dioxide to selectively extract and concentrate gingerols and shogaol. These extracts are thus free of potentially toxic organic solvents, and are tested and certified to be free of pesticides, herbicides and other contaminants.

The enhanced ginger concentrate is then formulated to achieve a specific concentration of gingerols and shogaol with all-natural liquid excipients designed to maximize the stability and bioavailability of the bioactive constituents [US Patent Pending]. The golden-brown formulation is then encapsulated into gel capsules (LiCaps™) with a nitrogen head by Capsugel, Inc., a subsidiary of Pfizer following cGMP.

Zindol® was recently evaluated in a multi-center, 644-patient, dose-finding, placebo-controlled, randomized Phase II/III clinical trial as an adjunctive therapy to conventional 5-HT3 anti-emetics for nausea in cancer patients undergoing chemo-therapy. This successful clinical trial was managed by the University of Rochester.