Joanna Cosgrove, Contributing Editor04.08.13
More than 70% of adults and 58% of children receiving chemotherapy report nausea and vomiting as a side effect of the treatment. Despite the availability of many pharmaceutical anti-emetic options, the effectiveness of these medicines can be hit or miss depending on the patient’s individual needs. On the heels of a series of successful clinical trials, Woburn, MA-based Aphios Corp. recently announced that its ginger-based Zindol product has been awarded a patent for combating the nausea and emesis brought on by chemotherapy.
Despite the widespread use of 5-HT3 receptor antagonist anti-emetics such as Palonosetron, chemotherapy-induced nausea continues to be a debilitating byproduct for adult patients and children receiving highly emetogenic chemotherapy. What’s more, the anti-emetics are associated with significant adverse effects such as sedation, extra-pyramidal side effects and hypotension as well as headache, diarrhea and constipation.
According to Aphios, there was a real need for an anti-emetic medication that didn’t deliver “clinically significant adverse effects,” so the clinical stage biotechnology company sought to develop its own solution, having already experienced success in the development of enhanced therapeutic products for health maintenance, disease prevention and the treatment of certain cancers, infectious diseases and neurological disorders such as Alzheimer’s disease.
The company’s Zindol product is a highly purified and standardized ginger product. “Our scientists and engineers utilized proprietary polarity-guided SuperFluids CXF fractionation technology to establish conditions for the isolation of the active pharmaceutical ingredients and then scaled-up production of gingerols using proprietary SuperFluids CXP manufacturing technology,” said the company’s Dr. Trevor P. Castor, president and CEO.
Aphios recently completed a successful Phase II/III clinical trial on Zindol as an adjuvant to conventional 5-HT3 anti-emetics. “This randomized, placebo-controlled, double-blind clinical trial assessed the efficacy of Zindol in treating chemotherapy induced nausea in 576 cancer patients,” explained Dr. Castor. “All doses of Zindol significantly reduced acute nausea severity compared to the placebo. No significant adverse events were reported.”
Zindol’s newly minted patent is titled, “Use of Gingerols for Cancer Patients Suffering from Nausea and Emesis Induced by Chemotherapy.”
The company plans to conduct a “pivotal” Phase III clinical trial on Zindol for the adjunctive treatment of nausea in adults undergoing chemotherapy, file an NDA and then initiate a clinical program in a pediatric population. In the interim, the product will be made available as a dietary supplement under the brand name Zindol DS. Zindol will also be developed for nausea caused by surgery, pregnancy, motion sickness and drugs.
Despite the widespread use of 5-HT3 receptor antagonist anti-emetics such as Palonosetron, chemotherapy-induced nausea continues to be a debilitating byproduct for adult patients and children receiving highly emetogenic chemotherapy. What’s more, the anti-emetics are associated with significant adverse effects such as sedation, extra-pyramidal side effects and hypotension as well as headache, diarrhea and constipation.
According to Aphios, there was a real need for an anti-emetic medication that didn’t deliver “clinically significant adverse effects,” so the clinical stage biotechnology company sought to develop its own solution, having already experienced success in the development of enhanced therapeutic products for health maintenance, disease prevention and the treatment of certain cancers, infectious diseases and neurological disorders such as Alzheimer’s disease.
The company’s Zindol product is a highly purified and standardized ginger product. “Our scientists and engineers utilized proprietary polarity-guided SuperFluids CXF fractionation technology to establish conditions for the isolation of the active pharmaceutical ingredients and then scaled-up production of gingerols using proprietary SuperFluids CXP manufacturing technology,” said the company’s Dr. Trevor P. Castor, president and CEO.
Aphios recently completed a successful Phase II/III clinical trial on Zindol as an adjuvant to conventional 5-HT3 anti-emetics. “This randomized, placebo-controlled, double-blind clinical trial assessed the efficacy of Zindol in treating chemotherapy induced nausea in 576 cancer patients,” explained Dr. Castor. “All doses of Zindol significantly reduced acute nausea severity compared to the placebo. No significant adverse events were reported.”
Zindol’s newly minted patent is titled, “Use of Gingerols for Cancer Patients Suffering from Nausea and Emesis Induced by Chemotherapy.”
The company plans to conduct a “pivotal” Phase III clinical trial on Zindol for the adjunctive treatment of nausea in adults undergoing chemotherapy, file an NDA and then initiate a clinical program in a pediatric population. In the interim, the product will be made available as a dietary supplement under the brand name Zindol DS. Zindol will also be developed for nausea caused by surgery, pregnancy, motion sickness and drugs.
