Cingles Info

Clinical Trial Results Show That Peregrine's First-In-Class Anti-Viral Agent
Tarvacin(TM) Is Safe And Well-Tolerated In HCV Patients
Article Date: 28 Feb 2006 - 0:00am (UK)
Peregrine Pharmaceuticals, Inc. (PPHM), a biopharmaceutical company with a
portfolio of innovative, clinical stage product candidates for viral diseases
and cancer, today announced that it will present top line data demonstrating
that its first-in-class anti-viral compound Tarvacin(TM) Anti-Viral appeared
safe and well-tolerated in a Phase l study in chronic hepatitis C virus (HCV)
infected patients. Initial results from the Phase l study will be presented at
1:50 pm EST today at the Strategic Research Institute's 2nd Annual "Viral
Hepatitis in Drug Discovery and Development" conference in Boston.
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 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 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.
"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 Anti-Viral 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.
Similar to their anti-viral 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.
Tarvacin Anti-Cancer is in Phase l clinical trials for the treatment of advanced
refractory solid tumor cancers.
About Peregrine
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio
of innovative product candidates in clinical trials for the treatment of cancer
and viral diseases. The company is pursuing three separate clinical trials in
cancer and anti-viral indications with its lead product candidates Tarvacin(TM)
and Cotara(R). Peregrine also has in-house manufacturing capabilities through
its wholly owned subsidiary Avid Bioservices, Inc. ( http://www.avidbio.com ),
which provides development and bio-manufacturing services for both Peregrine and
outside customers. Additional information about Peregrine can be found at
http://www.peregrineinc.com.
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