Jennerex Treats First Patients in Phase 2 JX-594 Trial for Liver Cancer



    
    Armed Poxvirus selectively destroys tumor cells

    Alliance with Rex Medical Announced for use of Quadra-Fuse Multi-pronged
    Injection Needles

    
    SAN FRANCISCO and YONGIN, South Korea, Jan. 12 /CNW/ -- Jennerex, Inc.
(San Francisco, CA and Ottawa, Ontario), and its South Korean partner Green
Cross Corp., today announced treatment of the first five patients in a Phase 2
primary liver cancer clinical trial using its targeted and armed poxvirus
JX-594. No significant toxicities were reported, and enrollment of patients
onto the trial is continuing.
    The Phase 2 trial involves treatment of patients with advanced, primary
liver cancer refractory to standard therapies. Patients are randomized to
receive treatment at one of two dose levels. The 30-patient, multi-national
trial is being conducted at clinical sites in the United States, South Korea
and Canada.
    "We're very excited to have this trial open and enrolling with our lead
product, JX-594, which has the potential to revolutionize the treatment of the
more than 10,000 patients each year who develop liver cancer in the U.S.
alone. The numbers of patients with liver cancer in the EU, Japan and Asia are
even higher. These desperate patients represent a huge unmet medical need
since few effective therapies are available for them," said David H. Kirn,
M.D., President and Chief Executive Officer of Jennerex.
    "We have already treated four patients with JX-594 in Korea and are
anxious to see the efficacy of JX-594 in these late stage liver cancer
patients," said B.G. Rhee, Ph.D., Executive Vice President of Green Cross.
    The primary objective for this trial is to study the efficacy of
treatment with JX-594 at two different dose levels in preventing tumor
progression, as measured by modified RECIST criteria at eight weeks from
initiation of treatment in patients with unresectable primary hepatocellular
carcinoma. In addition, safety and tolerability, as well as tumor response and
progression-free survival, of JX-594 administered at the two dose levels will
be evaluated. Up to 30 total patients will be treated.
    
    New Alliance for Use of Quadra-Fuse, Multi-pronged Injection Needles
    
    Jennerex also announced today an alliance with Rex Medical, a
manufacturer of advanced multi-pronged needles, for the targeted intratumoral
administration of JX-594.  Jennerex shall exclusively use Rex Medical
Quadra-Fuse needles ("QF Needles") for intratumoral injections of JX-594 in
clinical development, and Rex Medical shall work collaboratively with Jennerex
to effectively apply this technology to JX-594 clinical development.
    "We are excited to be collaborating with Rex Medical, the market leader
in this field, for application of Quadra-Fuse needle technology with JX-594.
This is the first needle designed for optimizing therapeutic delivery of
fluids/agents into target tissue zones. This innovative multi-pronged design
allows us to precisely target distribution of JX-594 for optimal therapeutic
effect. The result is an innovative and potentially landmark combination of a
highly targeted biotherapeutic agent with a sophisticated medical device for
targeted delivery," stated Dr. Kirn.
    
    About JX-594
    
    JX-594 is a cancer biotherapeutic product, currently in Phase 2 trials,
from a proprietary breakthrough class of targeted and armed oncolytic
poxviruses. Tumor destruction and safety was shown in patients with diverse
cancer types on three Phase 1 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. 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 2 trial for primary liver cancer, demonstrated
promising Phase 1 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 recombinant
Factor VIII and Factor IX for hemophilia, Hepatitis B Immunoglobulin
monoclonal antibody for liver transplantation, anticancer drugs such as
Greenstatin (anti-angiogenic peptide) and modified PEG-G-CSF for neutropenia.
For more information about Green Cross, please visit
http://www.greencross.com.
    
    About Rex Medical
    
    Rex Medical, LP, based in Conshohocken, Pennsylvania, is a privately held
medical device company specializing in the development, manufacturing and
marketing of minimally invasive medical devices targeted towards the oncology,
cardiovascular, venous access, and endosurgery markets.




For further information:

For further information: Samantha Miller, MSc. MBA, VP Corporate
Development of Jennerex, Inc., +1-415-281-8886, smiller@jennerex.com Web Site:
http://www.jennerex.com                 http://www.greencross.com

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