ImQuest Submits Investigational New Product Application To The Food And Drug Administration To Initiate HIV Therapeutic Clinical Trials With IQP-0410

Main Category: HIV / AIDS
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 08 Jan 2009 - 0:00 PDT

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ImQuest Life Sciences announced the successful submission of an IND application to the Food and Drug Administration to initiate human clinical trials for their lead pyrimidinedione HIV inhibitor IQP-0410. ImQuest anticipates initiating their Phase 1 studies in the first quarter of 2009. IQP-0410 is a novel small molecule inhibitor of HIV which primarily acts as a nonnucleoside reverse transcriptase inhibitor (NNRTI). The compound possesses a second mechanism of action which prevents the entry of HIV into target cells and significantly raises the potential genetic barrier to resistance with IQP-0410 therapy. Preclinical pharmacokinetic and toxicology studies have demonstrated the potential for once per day dosing and a high safety margin for the compound. IQP-0410 has been found to inhibit HIV replication at sub-nanomolar concentration levels and to have highly significant activity against all clinical virus strains evaluated as well as against multi-drug resistant virus strains obtained from patients failing long courses of therapy with currently approved RT and protease inhibitors. The compound is well suited for use as a component of primary HAART regimens as well as a salvage therapy option. Preclinical studies have also demonstrated the ability of the compound to be used in combination with all other approved HIV drugs.

"The submission of this IND represents a critical milestone in the therapeutic development of the pyrimidinedione class of molecules as potential new HIV drugs and an important success in the strategic drug development initiatives between ImQuest and Samjin Pharmaceutical Co. Ltd of Seoul, KOREA," said Dr. Robert W. Buckheit, Jr., Executive Vice President and Chief Scientific Officer of ImQuest Life Sciences. "We believe that IQP-0410 will be a new and novel addition to the armamentarium of HIV drugs available and provide HIV-infected individuals with a safe and effective alternative to current therapies."

ImQuest and Samjin have continued their strategic efforts to develop additional pyrimidinediones as next generation NNRTIs with an enhanced genetic barrier to resistance as well as efforts to develop a topical microbicide to prevent the sexual transmission of HIV. Additionally, ImQuest's development of Samjin's piperazine anti-tumor agents for the treatment of both solid and hematopoietic tumors has progressed to IND-enabling toxicology evaluations. These products are expected to enter human clinical trials in late 2009 and 2010.

ImQuest Life Sciences (http://www.imquest.com) in Frederick, Maryland specializes in the preclinical and clinical development of novel compounds for the treatment of infectious disease and cancer. ImQuest BioSciences (http://www.imquest.com) is a leading provider of anti-infective and anti-cancer drug and vaccine development services to the biotechnology and pharmaceutical industry. Established in 1968, Samjin Pharmaceutical Co. (www.samjinpharm.co.kr/eng) is dedicated to the manufacture, distribution and marketing of novel pharmaceuticals resulting in numerous international patents covering antiviral, anticancer, and metabolic candidate compounds. The company has recently expanded their scope to include stem cell research and the active pursuit of diabetic treatments.

ImQuest Life Sciences, Inc.
http://www.imquest.com