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 emetogenic 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 16^th century, practitioners of both Indian (Ayurvedic) and traditional Chinese medicine have used ginger (Zingiber officinalis, Roscoe) to treat gastrointestinal 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 and 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 shogaols, of ginger. 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. Raw materials utilized were organic grown and SuperFluids™ carbon dioxide was utilized to selectivity extract and concentrate gingerols and shogaols. The extracts are thus free of potentially toxic organic solvents, and have been tested to be free of pesticides, herbicides and other contaminants. The enhanced ginger concentrate is then formulated to achieve a specific concentration of gingerols and shogaols with all-natural liquid excipients designed to maximize the stability and bioavailability of the bioactive constituents. The golden-brown formulation is then encapsulated under cGMP conditions into gel capsules (LiCaps®) with a nitrogen head by a premier CRO, Capsugel, Inc., a Pfizer subsidiary.

Zindol® is currently in a multi-center Phase II/III, 708-patient, dose-finding, placebo-controlled, randomized clinical trial, managed by the University of Rochester Medical Center, for nausea in cancer patients undergoing chemotherapy. The primary objective of the clinical trial is to determine if Zindol™ is more effective than placebo in controlling chemotherapy-related nausea at cycle 2 or 3 in participants given a 5-HT₃ receptor antagonist antiemetic plus dexamethasone (or the equivalent dose of IV methylprednisolone) on day 1 of chemotherapy. The secondary objectives are to: determine the most effective dose of Zindol® for control of chemotherapy-related nausea; identify any adverse effects of Zindol® given for control of chemotherapy-related nausea; determine if Zindol® is more effective than placebo in controlling chemotherapy-related anticipatory nausea; determine if Zindol® is more effective than placebo in maintaining participants’ quality-of-life (QOL) during the four days following chemotherapy; and determine if Zindol® is more effective than placebo in controlling chemotherapy-related nausea at cycle 3 or 4 in participants given a 5-HT₃ receptor antagonist antiemetic plus dexamethasone (or the equivalent dose of IV methylprednisolone) on day 1.

Home l Company | Infectious Diseases | Oncology | Nutraceuticals | Product Pipeline | Purchase Products | Technology Platforms | Equipment |Patents | Press Releases | Contact Aphios