Peregrine Pharmaceuticals, a biopharmaceutical company with a portfolio of clinical stage product candidates for viral diseases and cancer, announced that it will present top line data demonstrating that its first-in-class anti-viral compound Tarvacin antiviral appears safe and well-tolerated in a Phase l study in patients with chronic hepatitis C virus (HCV).

Initial results from the Phase l study will be presented at at the Strategic Research Institute's 2nd Annual "Viral Hepatitis in Drug Discovery and Development" conference in Boston, MA.

Tarvacin 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 l study were to determine the safety profile and distribution properties of Tarvacin in patients with chronic hepatitis C viral infections. The data will support initiation of repeat dose and combination therapy trials that the company expects to begin later this year.

In the ascending, single dose trial, 24 patients with chronic 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.

"Demonstrating the safety of the new approach is a critical step in developing a first-in-class therapeutic, so this Phase l data indicating that Tarvacin appears to be safe and well-tolerated is a key milestone for the program," said Steven W. King, president and CEO of Peregrine. "Completing this study ahead of schedule with the safety profile observed should help us to expedite advancing the Tarvacin Anti-Viral HCV clinical program into repeat dose and combination therapy studies this year."

Tarvacin has shown promise in preclinical studies in a variety of anti-viral and biodefense applications. Anti-PS agents attach to phospholipids found on the surface of virus particles, including HCV, influenza and other virus strains, as well as on the outer surface of human host cells infected with these viruses. Anti-PS immunotherapeutics are believed to work by helping stimulate the body's natural immune defenses to destroy both virus particles and infected cells.

The targeted phospholipids are not exposed on healthy cells, which are therefore not affected by anti-PS agents. Since the targeted phospholipids are derived from the host rather than from the virus itself, anti-PS immunotherapeutics are expected to have broad activity against a variety of virus strains and to be less subject to the development of anti-viral drug resistance.

"Tarvacin represents a completely new approach to treating HCV infections, and these initial positive safety data are promising," said Dr. Eliot W. Godofsky, principal investigator of the Phase l 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, it's potential for use in combination regimens to control and ultimately cure HCV warrants further investigation."

Single administration of anti-viral agents is not generally expected to have a significant effect on HCV viral titers as a result of rapid virus production and turnover. However, viral titer data are being collected as part of the Tarvacin study design and are currently being analyzed. These data will be discussed in an appropriate future scientific forum along with final safety data from the Phase I trial.

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.

03/24/06

Source
Peregrine.