Positive Interim Results for JX-594 Randomized Phase 2 Liver Cancer Trial Presented at Major International Conference (EASL)
-- Data Demonstrate Increased Survival with Full Dose JX-594 in Advanced Liver Cancer Patients -- -- Phase 3 Study to Begin in 2010 --
SAN FRANCISCO and VIENNA, April 19 /PRNewswire/ -- Jennerex,
Inc. (San Francisco, CA and Ottawa, Ontario), a clinical-stage
cancer biotherapeutics company, today announced the presentation of
positive interim data from its randomized Phase 2 clinical trial
using JX-594 for the treatment of advanced hepatocellular carcinoma
(HCC), or liver cancer, at the 45th Annual Meeting of the European
Association for the Study of the Liver (EASL) in Vienna,
Austria.
The study results, presented today by the Principal Investigator
Jeong Heo, M.D., Ph.D., and titled "Randomized Phase II clinical
trial of intratumoral injection of JX-594, a targeted
multi-mechanistic oncolytic poxvirus, in patients with
hepatocellular carcinoma," demonstrated increased survival for the
full dose JX-594 treated group versus the low dose group (10% of
full dose), at both six and 12 months. Based on Kaplan-Meier
analysis, the six month survival of patients treated at low dose
and full dose was 48% and 75%, respectively and 12 month survival
was 18% and 75% for low and full dose, respectively. In addition,
the full dose JX-594 group had superior survival when compared to
historical controls including patients treated with sorafenib
(Nexavar®). The data also showed that, of 17 JX-594 treated
patients evaluated after eight weeks, disease was controlled in 15
(88%) patients (objective radiographic response or stable disease).
Fifty percent of evaluable patients achieved a Choi (necrotic)
response on dynamic contrast-enhanced MRI scan. Treatment was
typically associated with transient flu-like symptoms generally
lasting less than 24 hours. No patients had treatment discontinued
due to toxicities.
"The preliminary data presented today at EASL are very
encouraging and validate our clinical experience with JX-594 in
patients with advanced HCC who have failed other therapeutic
regimens. Patients treated with JX-594 appear to live longer with
an improved quality of life," said Dr. Heo. "Because JX-594 works
through a three-pronged mechanism of action--attacking cancerous
cells through cell lysis, immune stimulation and vascular
disruption -we believe it offers a new and promising therapeutic
modality for the treatment of liver cancer patients."
Jennerex's Phase 2 clinical trial, which has enrolled 24
patients to date, is evaluating the use of JX-594 to treat patients
with advanced, primary liver cancer refractory to standard
therapies. The multi-national study is currently enrolling patients
at clinical sites in the United States, Canada and South Korea.
Patients are randomized to receive JX-594 at one of two dose levels
given three times intratumorally at two-week intervals. Primary
endpoints of the trial are disease control at eight weeks evaluated
by Choi response and Response Evaluation Criteria in Solid Tumors
(RECIST).
"We are pleased to be reporting such promising interim results
today at EASL, a meeting that attracts leading hepatologists from
around the world focused on the discovery of new treatments for
hepatocellular carcinoma," said David H. Kirn, M.D., president and
chief executive officer of Jennerex. "We look forward to reporting
full results from this trial following its completion. We
anticipate opening our pivotal Phase 3 clinical trial evaluating
JX-594 in combination with sorafenib for first-line therapy of
advanced HCC later this year."
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 and immunotherapeutic poxviruses. Tumor destruction and
safety was shown in patients with diverse cancer types in 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 biotherapeutics 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 randomized Phase
2 clinical trial for patients with primary liver cancer,
demonstrated promising Phase 1 efficacy and safety results in
patients with a diverse array of common 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 not only cause cancer cell lysis thereby killing through
replication, they simultaneously shut off the blood supply to
tumors, as well as stimulating the body's immune response to the
cancer. Jennerex, Inc. is headquartered in San Francisco and has
manufacturing and research activities based at the Ottawa Hospital
Research Institute in Ottawa, Canada. For more information about
Jennerex and the Company's pipeline of three clinical-stage
products, please visit www.jennerex.com.
Source: Jennerex, Inc.
CONTACT: Jennifer Cook Williams of Cook Williams Communications,
Inc.,
+1-360-668-3701, or jennifer@cwcomm.org, for Jennerex,
Inc.
Web Site: http://www.jennerex.com/
Posted: April 2010
