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Jennerex Publishes Promising Results From Cancer Clinical Trial Of JX-594 In Lancet Oncology
Jennerex, Inc. (San Francisco, CA and Ottawa, Ontario), and its South
Korean partner Green Cross Corp., announced that Phase I clinical
trial results from its first-in-class lead product JX-594 were published in
the premier journal Lancet Oncology. The majority of these end- stage
patients with solid tumors had objective tumor destruction and responses
following treatment with the cancer biotherapeutic. Half of the
JX-594-treated patients survived for more than eight months, well beyond
their life expectancies of three to four months, and four patients with
tumor responses survived for 11 to over 18 months. Results were especially
promising for liver and lung cancer patients. Importantly, treatment with
JX-594 was shown to be well-tolerated. A Phase II clinical trial is now
underway for JX-594 in liver cancer. The world-wide liver cancer market is
estimated at over one billion dollars per year.
"These clinical results with JX-594 are a major step forward for this
novel therapeutic approach that Jennerex is pioneering. We are excited by
the potential to help the more than ten thousand patients each year who
develop liver cancer in the U.S. alone. These desperate patients represent
a huge unmet medical need since few effective therapies are available for
them. Our team here at UCSD is extremely excited to be a lead site for the
current Phase II trial of JX-594 for liver cancer," said Dr. Tony Reid,
M.D., Ph.D., Associate Professor and Director of Clinical Investigation at
the University of California, San Diego Moores Cancer Center.
"After years of methodical design and development to optimize our
products, these results in end-stage patients powerfully validate our
commitment to this breakthrough approach. The clinical results were
remarkably similar to what we predicted based on extensive lab testing of
JX-594. This peer-reviewed publication in a Lancet journal represents a
major advance for JX-594 and the rest of our pipeline," said David Kirn,
M.D., President & CEO of Jennerex. "We especially want to express our
extreme gratitude to the doctors, the patients and their families, and our
partners at Green Cross who have all pioneered this treatment with us."
Dr. B. G. Rhee, Executive Vice President, Corporate Development at
Green Cross, said "Based on these promising clinical results with our
partners at Jennerex, we are in the process of opening the Phase II liver
cancer trial at world-renowned liver cancer hospitals in South Korea."
Jennerex collaborated closely with medical and scientific research teams in
South Korea at Dong-A University and Pusan National University Hospitals,
and at the Ottawa Health Research Institute, Ottawa, Canada.
Phase I-II Liver Cancer Study
As reported in the Lancet Oncology publication, 14 patients with a
variety of treatment-refractory cancer types (e.g. liver, colon, lung) in
the liver were treated every three weeks with JX-594 by ultrasound-guided
intratumoral injection. Patients had advanced cancers that had failed all
available therapies and were therefore considered terminal. Treatment was
well-tolerated during dose-escalation up to the maximum-tolerated dose,
with the expected mild to moderate flu-like symptoms; no severe toxicities
due to treatment were reported up to these doses. Cancer destruction and
objective evidence for efficacy were reported in the majority of patients,
including all three with primary liver cancer and patients with lung and
colon cancers. Tumor responses were achieved in evaluable patients by
objective criteria including RECIST (Response Evaluation Criteria in Solid
Tumor) (response in 30 percent of patients, stable disease in 60 percent of
patients) and Choi criteria (response in 80% of patients). Tumor responses
were associated with long-term survival in many patients, including four
who survived for 11 to over 18 months. Mechanism-of-action of JX-594 was
validated in patients by demonstration of tumor-specific replication and
tissue destruction with JX- 594, in addition to high-level active
expression of the GM-CSF protein in the blood of patients. These results
led to the initiation of a Phase II liver cancer trial that is now open in
the U.S., and will shortly begin enrolling patients at sites in South Korea
and Canada, as well.
About JX-594
JX-594 is a cancer biotherapeutic, currently in Phase II trials, from a
proprietary class of targeted and armed oncolytic poxviruses. Tumor
destruction and safety was shown in patients with diverse cancer types in
three Phase I trials; treated patients were end-stage and had no effective
therapies available. JX-594 multiplies selectively within cancer cells,
leading to their destruction. These newly created copies of JX-594 are then
released and are able to infect and eradicate other tumor cells both
locally and in distant sites in the body. This cycle of JX-594 replication,
cancer cell destruction, release and spread is then repeated. Normal cells
are not affected by JX-594 resulting in safety and tolerability. The
poxvirus strain backbone of JX-594 has been used safely in millions of
people as part of a worldwide vaccination program against smallpox. This
strain naturally targets cancer cells due to common genetic defects in
cancer cells. JX-594 was engineered to enhance this natural safety and
cancer-selectivity by deleting its thymidine kinase (TK) gene, thus making
it dependent on the cellular TK expressed at persistently high levels in
cancer cells. To enhance product efficacy, JX-594 is also engineered to
express the GM-CSF protein. GM-CSF complements the cancer cell lysis work
of the product candidate, leading to a cascade of events resulting in tumor
necrosis, tumor vasculature shutdown and an anti-tumoral immune attack.
About Jennerex
Jennerex is a clinical-stage biopharmaceutical company focused on the
development and commercialization of first-in-class, breakthrough targeted
oncolytic products for cancer. The company's lead product JX-594, currently
in an international Phase II trial for primary liver cancer, demonstrated
promising Phase I efficacy and safety results in patients with a diverse
array of common large market cancers. Jennerex's products target, attack
and eradicate cancers through a novel and potent oncolytic mechanism that
is dependent on highly-specific replication of the company's poxviruses in
cancer cells. These products simultaneously stimulate the body's immune
response to the cancer. Of note, this mechanism of action and the results
in patients to date put the company's product class in a leadership
position. Jennerex's position is in marked contrast to gene therapy and
standard cancer vaccine approaches. For more information about Jennerex and
the company's robust pipeline and three clinical-stage products, please
visit http://www.jennerex.com.
About Green Cross Corporation
Green Cross is a leader in the Korean biotechnology and pharmaceutical
industries. Green Cross is now an internationally recognized biotechnology
company developing several vaccines and therapeutic proteins. Green Cross
will become the only seasonal influenza vaccine manufacturer in South Korea
and also is developing avian influenza vaccine. In its vaccine business,
Green Cross has successfully developed one of the earliest vaccines against
Hepatitis B (Hepavax), the first Epidemic Hemorrhagic Fever vaccine and the
world's second chicken pox vaccine. Green Cross is developing anticancer
drugs such as Greenstatin (anti-angiogenic peptide) and modified PEG-G-CSF
for neutropenia.
Jennerex
http://www.jennerex.com
Jennerex publicã promitator Rezultate din studiile clinice de Cancer Din JX-594 În Lancet Oncology - Jennerex Publishes Promising Results From Cancer Clinical Trial Of JX-594 In Lancet Oncology - articole medicale engleza - startsanatate