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news.ImQuest Pharmaceuticals was recently notified by the US Food and Drug Administration of the approval of its Investigational New Drug (IND) application to study the safety in Phase 1 clinical trials of its vaginal gel containing the nonnucleoside reverse transcriptase HIV Inhibitor IQP-0528.
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Preclinical studies have shown that IQP-0528 is highly effective against virus strains found throughout the world, prevents HIV transmission in cultured cells, causes sterilization of cultures infected with HIV, and acts in concert with other approved HIV drugs to inhibit the virus. The IQP-0528 vaginal gel is being developed with the goal of preventing the sexual transmission of HIV to women throughout the world.
ImQuest plans to evaluate the safety of the IQP-0528 vaginal gel in a Phase I clinical trial at medical centers in the United States and expects to begin recruiting women for the trial by the end of the year. This marks the company’s first product to receive FDA approval for clinical trials.
"The approval of our IND by the FDA is a major and highly significant milestone for ImQuest’s Women’s Health and Prevention programs focused on the protection of susceptible women from infection," said Dr. Robert Buckheit, Jr., President and Chief Scientific Officer of ImQuest. "In light of the unique properties of IQP-0528 we anticipate that the IQP-0528-containing gel will be a highly successful prevention agent and will be a first step towards our development of subsequent prevention and women’s health products."
ImQuest Pharmaceuticals developed the HIV inhibitor in partnership with Samjin Pharmaceutical Co. Ltd of Seoul Korea. Preclinical testing was conducted by ImQuest BioSciences of Frederick, Maryland using the company’s newly launched ImQuestSUCCESS™ platform, which enables the rapid identification of drug candidates with a high probability of clinical success early in the discovery and development process. Development of ImQuest’s prevention products has been supported in part by the National Institutes of Health and the International Partnership for Microbicides, which is funded by The Bill and Melinda Gates Foundation and The United States Agency for International Development (USAID).
The company plans to submit a second IND to the FDA for approval to test IQP-0528 in a DuoGel™ formulation for protection of both vaginal and rectal virus transmission to men and women early next year – a product which will represent a major advancement for microbicide products in the pharmaceutical industry.