Botanical Drug for Chemotherapy Induced Nausea and Vomiting

PROJECT SUMMARY Nausea and vomiting are among the most distressing side effects of chemotherapy. This unmet need is acute in the adult and pediatric populations undergoing chemotherapy and is the reason why up to 50% of patients refuse subsequent chemotherapy treatment. Despite the widespread use of the 5-HT3 and NK-1 receptor antagonist antiemetics, chemotherapy induced nausea and vomiting (CINV) continues to be reported by up to 70% of adult patients receiving highly emetogenic chemotherapy agents. These synthetic antiemetics are expensive and burdened with significant side effects. Additionally, an off-label anti-psychotic olanzapine is finding frequent use as a rescue medication despite its serious adverse side effects. There is a high unmet need for improved products to treat CINV without adverse side effects. To meet this unmet medical need, we are developing a botanical drug based on ginger which has been used for centuries, from Aisa to Egypt and North America to manage gastrointestinal stress. The overall goal of this proposal is to develop a highly purified and standardized ginger product, Zindol, as a botanical drug product for the treatment of CINV. In Phase I, we plan to develop and manufacture an improved, highly purified active pharmaceutical ingredient (API) of Zingiber Officinale as well as a formulated drug product (FDP) in gelatin capsules, characterize these products, conduct stability studies and establish release criteria. We will also perform an innovative in vitro nausea assays to define and control manufacturing. In Phase II, we will scale manufacturing, conduct IND-enabling in vivo toxicology and pharmacology GLP studies, meet with the FDA and establish the regulatory pathway for conducting clinical trials. In Phase III, we plan to conduct clinical trials on Zindol® for the treatment of nausea and emesis in adults undergoing chemotherapy, and license the botanical drug with strategic corporate partners to address the $3.4B marketplace.