Peregrine announces antiviral Tarvacin safe in hepatitis C patients

By Elaine Rigoli

Tampa, Fla., Feb. 27 - Peregrine Pharmaceuticals, Inc. announced Monday that Tarvacin Anti-Viral appeared safe and well tolerated in a phase l study in chronic hepatitis C-infected 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, according to a news release.

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 company said the data will support initiation of repeat dose and combination therapy trials that it 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 Anti-Viral.

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, the release said.

"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 chief executive officer, in a statement.

"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 Anti-Viral has shown promise in preclinical studies in a variety of antiviral and biodefense applications, the release said. 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.

Similar to their antiviral mechanism, anti-PS immunotherapeutics also bind to phospholipids exposed on tumor blood vessels in all solid cancers tested to date, and they have shown promise in a number of preclinical cancer models, the release said. Tarvacin Anti-Cancer is in phase l clinical trials for the treatment of advanced refractory solid tumor cancers.

Tustin, Calif.-based Peregrine is a biopharmaceutical company with a portfolio of innovative product candidates in clinical trials for the treatment of cancer and viral diseases.

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