Pharmaceuticals' Partner ChronTech Initiates Phase II Clinical
Trial of Hepatitis C Virus DNA Vaccine Using Inovio's Electroporation
In Phase I trial 83% of patients showed undetectable hepatitis
C virus levels
Bell, Pa. -- March 14, 2011 -- Inovio Pharmaceuticals, Inc. (NYSE
Amex: INO), a leader in the development of therapeutic and preventive
vaccines against cancers and infectious diseases, announced today
that its partner, ChronTech Pharma AB (formerly Tripep AB), has
initiated a Phase IIb clinical study of its ChronVac-C DNA vaccine
for hepatitis C virus (HCV), delivered by Inovio's proprietary
electroporation DNA vaccine delivery technology, in combination
with standard of care.
In a Phase I clinical trial of ChronVac-C using Inovio's MedPulser
electroporation device the therapy resulted in a robust increase
in T-cell immune responses against HCV and was safe and well-tolerated.
Post-study observation of subjects who completed the protocol
and then entered into standard of care (SOC) treatment using interferon
and ribavirin showed a complete and rapid viral response (four
weeks) in 70% of those participants (5 of 7 patients). More significantly,
83% of the participants (5 of 6 patients) who were monitored for
an extended period of time, continued to be free of the virus
six months after they completed SOC. SOC treatment alone usually
results in about 40-50% of patients reaching undetectable virus
levels after six months of treatment.
This Phase II follow-on trial is an open-label, single-dose, randomized
trial of 32 patients to further explore the effect of the ChronVac-C
DNA vaccine administered by Inovio's MedPulser electroporation
delivery device. The therapy will be given two times, with four
weeks in between, followed by SOC treatment after the final vaccine
dose in treatment-naive chronic HCV infected genotype-1 subjects.
This trial will assess the level of immune responses, levels of
HCV viral load, and further assess the response to the delivery
technology. Twenty patients will receive ChronVac-C vaccine delivered
with Inovio's electroporation device; the 12-patient comparison
group will receive standard-of-care treatment alone. The study
has received approval from the Swedish Medical Products Agency
and local ethical committee.
we can repeat the Phase I results in this phase IIb study there
is certainly a possibility that vaccination with ChronVac-C before
drug therapy could become a part of the standard of care therapy
for patients with chronic hepatitis C-virus infection. In particular,
we hope that vaccination with this novel therapy will result in
a considerable shortening of the duration of interferon and ribavirin
treatment," said Anders Vahlne, CEO of ChronTech Pharma AB.
Dr. J. Joseph Kim, Inovio's president and CEO, said: "We
are encouraged by the phase I results showing the improved cure
rate in patients who received the HCV vaccine followed by a SOC
drug therapy. Any improvement to the HCV standard of care response
rates would be well-received by HCV patients and practitioners.
We are pleased to collaborate in this advancement of ChronVac-C,
using Inovio's innovative delivery technology, into Phase II."
About Inovio's Electroporation-Based Delivery Technology
Inovio's electroporation-based DNA delivery systems can increase
the cellular uptake of an agent by 1,000 times or more. When used
to deliver DNA vaccines, Inovio's systems can increase levels
of gene expression (i.e. production of the coded protein) and
immune responses by 100 times or more compared to plasmid DNA
delivered without other delivery enhancements. Inovio has recently
reported best-in-class immune responses with DNA vaccines for
cervical dysplasias/cancers and HIV. Inovio has also shown the
safety and tolerability of its electroporation devices in many
hundreds of patients and continues to advance device innovations
to further enhance the utility of these devices for mass vaccinations.
Inovio Pharmaceuticals, Inc.
is developing a new generation of vaccines, called DNA vaccines,
to treat and prevent cancers and infectious diseases. These SynCon
vaccines are designed to provide broad cross-strain protection
against known as well as newly emergent strains of pathogens such
as influenza. These vaccines, in combination with Inovio's proprietary
electroporation delivery devices, have been shown to be safe and
generate significant immune responses. Inovio's clinical programs
include HPV/cervical dysplasia and cancer (therapeutic), avian
flu (preventive), and HIV vaccines (both preventive and therapeutic).
Inovio is developing universal influenza and other vaccines in
collaboration with scientists from the University of Pennsylvania.
Other partners and collaborators include Merck, National Cancer
Institute, U.S. Military HIV Research Program, NIH, HIV Vaccines
Trial Network, University of Southampton, and PATH Malaria Vaccine
Initiative. More information is available at www.inovio.com.