Press Releases and News

United States Patent Office Issues Patent for Zindol®
September 27, 2013
Woburn, Mass. − Aphios Corporation is pleased to announce that United States Patent "Use of Gingerols for Cancer Patients Suffering from Nausea and Emesis Induced by Chemotherapy" No. 8,435,575 has been issued by the USPTO on May 17, 2013.

The issued patent is for Zindol, which is a highly purified ginger product that is standardized by the bioactive constituents, gingerols and shogaol, of ginger (Zingiber officinale, Roscoe). The patent covers the formulation, composition of the bioactive constituents in the formulation, excipients in the formulation designed to increase stability and bioavailability, use of the formulation and schedule of its use for nausea in cancer patients undergoing chemotherapy. The patent term extends to May 13, 2030.

"A successful Phase II/III clinical trial on Zindol as an adjuvant to conventional 5-HT3 anti-emetics has been completed," said Dr. Trevor P. Castor, President and CEO. "This randomized, placebo-controlled, double-blind clinical trial assessed the efficacy of Zindol in treating chemotherapy induced nausea in 576 cancer patients. All doses of Zindol significantly reduced acute nausea severity compared to the placebo. No significant adverse events were reported."

Dr. Castor continues that "These results are significant since most patients undergoing chemotherapy continue to experience nausea despite widespread use of 5-HT3 receptor antagonist anti-emetics and NK-1 antagonists as adjuvants." These anti-emetics appear to be no of benefit in terms of the incidence of nausea and have side effects. Zindol has shown efficacy in the treatment of this important problem associated with chemotherapy.

Zindol can dramatically improve the quality of life of cancer patients undergoing chemotherapy by reducing the incidence of nausea without clinically significant adverse effects. We plan 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.

Zindol will also be clinically developed for nausea caused by anesthesia after surgery, the first trimester of pregnancy, motion sickness in planes, cars and trains and at sea, and drugs for migraine headaches, Alzheimer's disease and other chronic diseases.

ABOUT APHIOS CORPORATION
Aphios® Corporation, a clinical-stage biotechnology company, is developing enhanced therapeutics for chronic, debilitating diseases and improving quality of life. Using advanced scientific and engineering techniques, we are developing green, enabling technology platforms for improving drug discovery and manufacturing, nanotechnology drug delivery, viral vaccines, and virus-free human plasma and biologics. Based on these platforms, Aphios is developing quality-of-life medicines for health maintenance and disease prevention, and enhanced therapeutics for the treatment of certain cancers and supportive care, infectious disease such as HIV, and CNS disorders such as Alzheimer's disease.

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