ImQuest Pharmaceuticals Receives FDA Approval to Initiate Clinical Trials of a Vaginal Gel for the Prevention of HIV Transmission to Women
July 16, 2014
Frederick, MD - July 16, 2014 - 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. 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.
About ImQuest Pharmaceuticals
ImQuest Pharmaceuticals is a leading drug discovery and development company with a highly focused strategy of developing a proprietary portfolio of novel agents for the prevention of infectious disease as well as products for Women's Health. The pipeline includes vaginal gels, dual vaginal/rectal DuoGels, films and intravaginal rings as prevention products and has significant efforts directed at the use of transdermal delivery of pharmaceutical products. The company has an exclusive development relationship with Samjin Pharmaceuticals with a right of first refusal to their products for the prevention and treatment of infectious disease. ImQuest Pharmaceuticals plans to strategically develop their topical microbicides product pipeline to provide prevention products to both men and women to inhibit the transmission of HIV and other sexually transmitted infectious (STI) organisms. ImQuest Pharmaceuticals' business model is to commercialize exciting new drugs with unique mechanisms of action both independently as well as in partnership with other pharmaceutical companies. For more information, visit www.imquestls.com.
About ImQuest BioSciences
ImQuest BioSciences is a preclinical contract research and development company that evaluates the potential of new and novel pharmaceutical products. ImQuest provides expert laboratory research services to define the efficacy and toxicity of pharmaceutical products and specialize in the development of drugs, vaccines and biologic products for the treatment and prevention of infectious disease, cancer and inflammatory disease. ImQuest is committed to earning our client's trust and building long term relationships through collaboration, unwavering commitment to quality science and consistent and effective communication. ImQuest has recently released the ImQuestSUCCESS platform which will significantly expedite the development of pharmaceutical products with enhanced probability for successful clinical development. ImQuest understands that each product and each client is unique and strives to provide effective solutions. For more information, visit www.imquestbio.com.Return to Press Releases