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Sequoia Pharmaceuticals Presents Proof of Clinical Concept of SPI-452, a Novel Pharmacokinetic Enhancer
Date:2/9/2009

MONTREAL, Feb. 9 /PRNewswire/ -- Sequoia Pharmaceuticals presented positive results today from two phase 1 studies in healthy volunteers and preclinical studies on SPI-452, a novel pharmacokinetic enhancer (PKE) with no inherent antiviral activity. Pharmacokinetic enhancers increase drug levels of co-administered agents through inhibition of cytochrome P450 (CYP)-mediated drug metabolism. These increased drug levels can lead to improved efficacy, reduced pill burden, and reduced daily dosing. Because of the risk of developing drug resistance, there is a need for new PKEs that have no antiviral activity. The only currently available PKE for use in HIV therapy is ritonavir, a protease inhibitor that has inherent antiviral activity. SPI-452 was designed to be a potent inhibitor of CYP3A enzymes with no antiviral activity and an improved safety profile; thereby, enhancing treatment options for patients who would benefit from a PKE given as a stand-alone agent or as part of a fixed-dose combination. These data were presented at the 16th Conference on Retroviruses and Opportunistic Infections on Monday, February 9, 2009, in Montreal, Canada.

Pharmacokinetic data from a 2-week, repeat-dose, proof-of-clinical-concept study and a single ascending-dose, first-time-in-human study conducted in healthy volunteers demonstrated that SPI-452 substantially enhanced the exposures of three currently approved HIV protease inhibitors (PIs). SPI-452 was generally safe and well tolerated, with few side effects. Furthermore, there were no statistically significant changes in triglyceride and low- density lipoprotein (LDL) cholesterol levels in subjects receiving SPI-452 compared with placebo, which may indicate that SPI-452 has a favorable lipid profile, an attribute that is in increasing demand in the treatment of HIV. These first-time-in-human and proof-of-clinical-concept data support the further investigation of SPI-452 and validate the
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