Jennerex, Inc. Receives EMEA Orphan Drug Designation for JX-594 for the Treatment of Hepatocellular Carcinoma

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Mon Oct 19, 2009 8:34am EDT

Jennerex, Inc. Receives EMEA Orphan Drug Designation for JX-594 for the
Treatment of Hepatocellular Carcinoma





SAN FRANCISCO, Oct. 19 /PRNewswire/ -- Jennerex, Inc. (San Francisco, CA and
Ottawa, Ontario), a clinical stage biotherapeutics company developing a
proprietary breakthrough product class of targeted oncolytic virus
therapeutics, today announced that the European Medicines Agency (EMEA) has
granted Orphan Drug Designation to Jennerex's product JX-594 for the treatment
of hepatocellular carcinoma (HCC), the most common form of liver cancer. 
JX-594 is expected to enter a Phase 3 pivotal trial in the second half of
2010.


European Orphan Drug Designation encourages the development of products that
demonstrate promise for the treatment of a life-threatening or chronically
debilitating condition affecting no more than five in 10,000 persons in the
European Union.  The designation criteria also specify that there is no other
satisfactory therapy for that indication and that if JX-594 is shown to be
effective in pivotal trials, it would represent a significant clinical benefit
to HCC patients.  Orphan Drug status for JX-594 entitles Jennerex to 10 year
market exclusivity in Europe if the Market Authorization Application (MAA) is
approved as well as potentially increasing reimbursement pricing. The
designation also confers special benefits, including eligibility for protocol
assistance and possible exemptions or reductions in certain regulatory fees
during development or at the time of application for marketing approval.


"This designation is an important step in the development of a potential
breakthrough treatment for this lethal disease," said David H. Kirn, M.D.,
President and Chief Executive Officer of Jennerex. "We look forward to working
closely with the European regulatory authorities to complete the global
development of JX-594 for the treatment of primary liver cancer."


About Hepatocellular Carcinoma
The treatment of advanced hepatocellular carcinoma represents a significant
unmet medical need.  HCC is responsible for about 90 percent of the primary
malignant liver tumors in adults.  Most cases of HCC are secondary to either a
viral hepatic infection (hepatitis B or C) or cirrhosis (alcoholism being the
most common cause of hepatic cirrhosis).  The usual outcome for patients is
poor, because only 10 to 20 percent of hepatocellular carcinomas can be
removed completely using surgery. If the cancer cannot be completely removed,
the disease is usually deadly within three to six months.


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.

Jennifer Cook Williams of Cook Williams Communications, Inc., +1-360-668-3701,
jennifer@cwcomm.org, for Jennerex, Inc.
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