Jennerex Completes the Treatment of First Patient Cohort in Phase 1 Trial with Intravenous Delivery of JX-594 Oncolytic Virus



    
    12 Patient Trial Targets Advanced Solid Tumors, Including Lung Cancer

    
    SAN FRANCISCO, Oct. 15 /CNW/ -- Jennerex, Inc. (San Francisco, CA and
Ottawa, Canada) today announced the completion of treatment for the first
patient cohort in the Phase 1 cancer clinical trial of its targeted poxvirus
JX-594, delivered by intravenous (IV) infusion. No significant toxicities were
reported, and treatment was well-tolerated.
    The Phase 1 IV trial involves treatment of patients with advanced,
metastatic solid tumors refractory to standard therapy. Patients receive
treatment at one of five dose levels in a sequential dose-escalating design;
the first cohort has now been treated safely. Once the maximum tolerated dose
is defined, an additional three to six patients will be enrolled at that dose
level. The trial is being conducted initially at clinical sites in the United
States, and will subsequently open at sites in Canada.
    "We're very excited to have this trial open and enrolling with our lead
product, JX-594. The safe delivery of JX-594 through intravenous
administration is a major milestone for our Company," said David H. Kirn,
M.D., President and Chief Executive Officer of Jennerex. "IV therapy allows
treatment of major market cancers including non-small cell lung cancer. These
data confirm the safety and feasibility of systemic dosing and tumor targeting
that were reported in liver tumor patients treated previously."
    The primary objective for this trial is to determine the maximum
tolerated and/or feasible dose of JX-594 administered IV. In addition, IV
delivery of JX-594 to solid tumors will be evaluated. An estimated total of 12
to 15 patients will be treated.
    
    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 Biotherapeutics was established in San Francisco and in Ottawa
in 2006 with Dr. David Kirn (CEO) in San Francisco and Dr. John Bell (CSO)
from the Ottawa Health Research Institute/University of Ottawa. 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.




For further information:

For further information: David H. Kirn, President & CEO of Jennerex,
Inc., +1-415-281-8886, cell, +1-415-847-7326, dkirn@jennerex.com Web Site:
http://www.jennerex.com

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