Heidelberg's fosalvudine to enter Ph II

German drugmaker Heidelberg Pharma GmbH has successfully completed the first clinical Phase I study of its investigational antiretroviral fosalvudine tidoxil in HIV-1 patients.

The open-label, single-dose study investigated the safety, tolerability and pharmacokinetics of orally-administered fosalvudine and, according to its principal investigator, Pedro Cahn, the agent proved to be "safe and well-tolerated at all dose levels tested." Heidelberg added that no serious adverse occurrences or other clinically relevant side effects were reported. Fosalvudine plasma concentrations were reached that exceeded the concentrations required to inhibit replication of HIV-1 clinical isolates in human cells in vitro. The firm noted that the agent is its third drug candidate now entering Phase II clinical trials.