Peregrine antiviral demonstrates safety in hepatitis patients

Tarvacin Anti-Viral is the first in a new class of anti-phosphotidylserine (PS) immunotherapeutics that targets and binds to cellular components that are normally not present on the outside of cells, but which become exposed on certain virally infected cells and on the surface of enveloped viruses. Tarvacin helps stimulate the body’s immune defenses to destroy both the virus particles and the infected cells.

The primary goals of the phase I study were to determine the safety profile and distribution properties of Tarvacin in patients with chronic hepatitis C viral infections.

In the ascending, single dose trial, 24 patients infected with chronic hepatitis C virus (HCV) who had either failed or who no longer responded to standard-of-care treatment were administered Tarvacin. The drug was well tolerated, with no serious adverse events reported at any of the four dose levels tested, and no potential dose limiting toxicities were observed. Reported adverse events were mild, infrequent, transient and likely not drug-related.

This data will support initiation of repeat dose and combination therapy trials that Peregrine expects to begin later this year.

“Tarvacin represents a completely new approach to treating HCV infections, and these initial positive safety data are promising,” said Dr Eliot Godofsky, principal investigator of the phase I study. “While there are a number of new HCV drugs in development, Tarvacin’s unique mechanism has the potential to combat the virus in a novel way. In addition, its potential for use in combination regimens to control and ultimately cure HCV warrants further investigation.”

Based on the good safety observed in the highest dose of Tarvacin tested, Peregrine may assess one additional dose level by adding another cohort to the existing HCV study through a protocol amendment. This addition is not expected to affect the timing of the new studies now being planned.