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news.The FDA has recommended that Pro-Pharmaceuticals provide the chemistry, manufacturing and controls information in order to secure the approval of its cancer drug Davanat.
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Davanat is co-administered with 5-Fluorouracil (5-FU) to treat cancer patients. 5-FU is an FDA-approved chemotherapy drug that is used to treat various types of cancers, including colorectal, breast and gastrointestinal and is one of the most widely used chemotherapy drugs in the world.
Davanat is a target delivery technology that may enhance the safety and efficacy profile of a variety of FDA-approved drugs. The company is developing and expanding its pipeline of drug candidates using Davanat and 5-FU in combination with other chemotherapeutics and biologics, such as irinotecan and Avastin.
Pro-Pharmaceuticals is currently conducting two phase II trials that are evaluating Davanat with 5-FU in first line therapy in biliary and colorectal cancers. The company successfully completed a phase I trial for end-stage cancer patients with all solid tumors and a phase II colorectal cancer trial for end-stage patients.