EANS-Adhoc: Intercell and Romark join forces in combining therapies against Hepatitis C

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21.10.2010

» The companies are designing a treatment that combines Intercell's
investigational Hepatitis C vaccine, IC41, with Romark's antiviral drug,
nitazoxanide.
» A combination Phase II trial is expected to start in H1/2011.
» The trial will be sponsored by Romark. Intercell will provide the vaccine
candidate IC41.

Vienna (Austria), October 21, 2010 - Intercell AG (VSE; "ICLL") and Romark
Laboratories L.C. today announced plans to commence clinical trials of
Intercell's investigational therapeutic Hepatitis C virus (HCV) vaccine, IC41,
in combination with Romark's antiviral drug, nitazoxanide, during the first half
of 2011.

Intercell's vaccine candidate has demonstrated a sustained reduction of viral
load in chronic Hepatitis C (CHC) patients in a Phase II proof-of-concept trial.
Nitazoxanide is an oral therapy that targets host cell factors involved in HCV
replication and is not associated with viral mutations conferring resistance.
Nitazoxanide has been shown to induce sustained virologic response as
monotherapy in some patients chronically infected with HCV.

The planned European Phase II trial will include about 60 treatment-naïve
patients chronically infected with HCV genotype-1 in three treatment arms: (1)
IC41 plus nitazoxanide, (2) IC41 plus nitazoxanide and Pegasys® (peginterferon
alfa-2a) and (3) Pegasys and Copegus® (ribavirin), the current standard of care,
as an active control. The primary endpoint will be sustained virologic response
(no detectable HCV RNA 24 weeks after end-of-treatment).
The companies involved in the combination study will retain commercial rights
for their respective products.

"We are very pleased about this important next step in the development of our
vaccine candidate against Hepatitis C. The distinctly different mode-of-action
and the outstanding tolerability of both treatments create a joint approach in a
field that will continue to have high unmet medical need over the next decades,"
stated Gerd Zettlmeissl, CEO of Intercell.

"We are excited about this novel therapeutic approach for chronic Hepatitis C,"
said Jean-François Rossignol, M.D., Ph.D., Chairman and Chief Science Officer of
Romark. "There is an important need for novel therapies that offer improvements
in safety and efficacy compared to current standard therapy. Our development
program for nitazoxanide in combination with peginterferon addresses this need
and promises to change paradigms for therapy of chronic Hepatitis C. The planned
study of nitazoxanide in combination with Intercell's therapeutic vaccine
further underscores our commitment to being a leader in the development of
next-generation therapies."

Intercell's investigational therapeutic vaccine has been designed to restore an
effective immune response against HCV, which ultimately is deemed necessary for
sustained clearance of the virus. In a successful proof-of-concept trial
involving around 50 treatment-naïve genotype-1 CHC patients, an optimized
schedule of therapeutic vaccination achieved viral load reductions of more than
75% (0.6 log) in patients with high baseline RNA levels. Importantly, this
reduction was sustained for at least six months following the end of treatment.
As in previous trials with the vaccine from Intercell, vaccination was safe and
well tolerated with minimal side effects.

Nitazoxanide, the first of a new class of broad-spectrum antiviral drugs called
the thiazolides,1,2,3 is an investigational new drug for CHC. It is a potent
inhibitor of HCV in replicon studies,2 and laboratory studies indicate that it
does not induce viral mutations that confer drug resistance.3,4 Nitazoxanide is
synergistic with interferon and direct acting antivirals in replicon studies.2,5
In a clinical trial of nitazoxanide monotherapy in patients with genotype 4 CHC,
17% (4 of 23) patients achieved sustained virologic response (undetectable serum
HCV RNA 24 weeks after end of therapy), with all responders having low baseline
serum HCV RNA levels (<400,000 IU/mL).6 In other clinical trials, the addition
of nitazoxanide to peginterferon or peginterferon plus ribavirin was associated
with improvement in sustained virologic response rates without increasing the
toxicities associated with peginterferon and ribavirin.7,8 Romark is preparing
to initiate Phase III clinical trials of nitazoxanide plus peginterferon for
treatment of CHC.

About Hepatitis C

HCV is a major cause of chronic liver disease, including cirrhosis and liver
cancer. According to the World Health Organization (WHO), approximately 170
million people worldwide are chronic HCV carriers (3% of the world's
population), including about 10 million Europeans, 3.9 million Americans and 2
million Japanese. 35,000 new infections occur in the United States alone each
year. The substantial unmet medical need is underscored by the fact that each
year 8,000 to 10,000 deaths and 1,000 liver transplants in the United States are
due to HCV.
Currently, there is no vaccine against HCV available, and the infection can only
be treated with a combination of interferon and ribavirin - a long-term therapy
with limited efficacy and substantial side effects. It also gives rise to high
treatment costs for patients. In 2002, worldwide sales of HCV drugs totaled
around EUR 2.8bn, and demand has since grown significantly. The market has been
seen to expand to about EUR 3.5bn by 2006.

About Romark Laboratories

Romark Laboratories, L.C. (www.romark.com) is a privately owned
biopharmaceutical company committed to the discovery and development of
innovative new small molecules for treating infectious diseases and cancers.
The Company is developing a new class of broad-spectrum antiviral drugs called
the thiazolides. The first thiazolide, nitazoxanide, is in late-stage clinical
development as a treatment of chronic hepatitis C and influenza. Other new
thiazolides are expected to enter clinical development in 2011.
Romark markets Alinia® (nitazoxanide) tablets, 500 mg and Alinia® (nitazoxanide)
for Oral Suspension, 100 mg/5 mL in the United States.

----------------------------------
1 Rossignol JF. Thiazolides: A new class of antiviral drugs. Expert Opin Drug
Metab Toxicol. 2009;5:667-674.
2 Korba BE, Montero AB, Farrar K, et al. Nitazoxanide, tizoxanide, and other
thiazolides are potent inhibitors of hepatitis B virus and hepatitis C virus
replication. Antivir Res. 2008;77:56-63.
3 Korba BE, Elazar M, Lui P, et al. Studies of the potential for hepatitis C
virus resistance to nitazoxanide or tizoxanide. Antimicrob Agents Chemother.
2008;52:4069-4071.
4 Yon C, Viswanathan P, Rossignol JF, Korba BE. Resistance to nitazoxanide is
associated with alterations in the host and not the virus in HCV replicon-
containing cultures. Submitted for publication.
5 Korba BE, Elazar M, Liu P, et al. Potential role for nitazoxanide in
combination with STAT-C agents for the inhibition of HCV replication without
the development of resistance. Hepatology. 2008;48(suppl):356A.
6 Rossignol JF, Kabil SM, El-Gohary Y, Elfert A, Keeffe EB. Clinical trial:
randomized, double-blind, placebo-controlled study of nitazoxanide
monotherapy for the treatment of patients with chronic hepatitis C genotype
4. Aliment Pharmacol Ther. 2008;28:574-580.
7 Rossignol JF, Elfert A, El-Gohary Y, et al. Improved virologic response in
patients with chronic hepatitis C genotype 4 treated with nitazoxanide plus
peginterferon alfa-2a with or without ribavirin. Gastroenterology.
2009;136:856-862.
8 Rossignol JF, Elfert A, Keeffe EB. Treatment of chronic hepatitis C using a
4-week lead-in with nitazoxanide before peginterferon plus nitazoxanide.
J Clin Gastroenterol. 2010;44:504-509.

Further inquiry note:
Intercell AG
Lucia Malfent
Vice President, Global Head Corporate Communications
Tel. +43 1 20620-1303
[email protected]
end of announcement euro adhoc
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issuer:      Intercell AG
             Campus Vienna Biocenter  3
             A-1030 Wien 
phone:       +43 1 20620-0
FAX:         +43 1 20620-800
mail:        [email protected] 
WWW:         www.intercell.com
sector:      Biotechnology
ISIN:        AT0000612601
indexes:     ATX Prime, ATX

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