SciClone: SCV-07 demonstrates oral bioavailability

By E. Janene Geiss

Philadelphia, Sept. 15 - SciClone Pharmaceuticals, Inc. said Friday phase 1 data indicates that SCV-07 taken orally was safe and led to circulating plasma concentrations similar to those obtained in previous phase 1 studies using a subcutaneous injection of SCV-07.

Importantly, SCV-07 taken orally resulted in only 10% plasma level variability between all volunteers in this study, demonstrating highly predictable plasma concentrations after oral dosing of this drug, the San Mateo, Calif., pharmaceutical company said in a news release.

The pilot study was designed to evaluate the oral availability of SCV-07 in healthy volunteers. A total of 24 volunteers were randomized into one of three groups receiving SCV-07 in an oral tablet, subcutaneous injection, or sublingual liquid dose at the beginning of each week for a three-week period. During the day after dosing, blood levels of SCV-07 were measured for each volunteer. In overall results, SCV-07 showed sufficient oral availability versus subcutaneous injection. SCV-07 did not show sublingual availability.

These results provide the company with a solid platform from which to compare different dosing regimes in future human studies and to evaluate alternate indications in its ongoing animal model studies.

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