euro adhoc: Intercell AG
Recruitment completed for
optimization trial of therapeutic Hepatitis C vaccine
Disclosure announcement transmitted by euro adhoc. The issuer is responsible for the content of this announcement.
Vienna (Austria), May 3, 2005 - Intercell AG (Vienna Stock Exchange: ICLL), today announced completion of recruitment in a new clinical trial of its therapeutic vaccine IC41 against Hepatitis C optimizing the route and frequency of vaccinations. The vaccine has been tested in a Phase II clinical trial in non-responders to Interferon/Ribavarin therapy, a very difficult to treat group. In this trial an induction of T-cells was observed in a subset of patients that was concomitant with a transient reduction of viral load (HCV RNA). The results of the completed Phase I and II trials were presented on April 14th at the conference of the European Association for the Study of the Liver (EASL) in Paris. The current follow up study has been designed to further increase the T-cell response that is pivotal to fight the infection by optimizing the route and the frequency of vaccinations. The new study is being performed at the General Hospital of Vienna, where Intercell´s IC41 Hepatitis C vaccine, is applied to over 50 healthy volunteers by administering up to 16 vaccinations at weekly intervals. Should results warrant, the study will be extended to chronic HCV patients with a less compromised immune system in 2006. The start of Phase III registration trials is planned for 2008, allowing entry into a market that is seen at greater EUR 3.5 bn per year in 2011. Prof. Michael Manns from the Medical University in Hanover states: "I am convinced that the achieved induction of T-cells in chronic non-responders patients as shown in Intercells Phase II study has paved the way to the development of a therapeutic vaccine for novel stand alone and combination treatments". Alexander von Gabain, CEO of Intercell, says: "We belong to the few pioneers working on new treatments against Hepatitis C. Our therapeutic vaccine in this field of high medical need is latest state of the art vaccine technology".
About IC41: IC41 is a fully synthetic vaccine designed for treatment of chronic HCV patients combining the T-cell adjuvant Poly-L-Arginine with 5 peptides, identified through studies of people with natural immunity to HCV or successful response towards Interferon/Ribavirin standard therapy. IC41 has completed Phase I and II trials confirming an excellent safety profile. IC41 is also being tested in combination with standard therapy in another Phase II trial. This trial is expected to be completed in 2006.
About HCV: HCV is a major cause of chronic liver disease, including cirrhosis and liver cancer. According to the World Health Organization (WHO), worldwide, approximately 170 million people are chronic HCV carriers (3% of the worlds population), including about 10 Million Europeans, 3.9 Million Americans and 2 Million Japanese are infected with HCV, and 35.000 new infections occur in the US alone each year. The high unmet medical need is underscored by the fact that each year 8,000 to 10,000 deaths and 1,000 liver transplantations are due to HCV in the US only. Currently, there is no vaccine against Hepatitis C and the infection can only be treated with a combination of Interferon and Ribavirin - a long-term therapy with limited efficacy and significant side effects. It gives rise to very high annual costs per patient. In 2002, worldwide sales of HCV drugs totalled at around EUR 2.8 bn, and demand is growing fast. The market is seen to be expanding to EUR 3.5 bn by 2006.
This communication expressly or implicitly contains certain forward-looking statements concerning Intercell AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Intercell AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Intercell AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.
The information contained herein is not for publication or distribution in the United States of America. This press release is not an offer of securities for sale in the United States. Securities may not be offered or sold in the United States absent registration or an exemption from registration under the U.S. Securities Act of 1933, as amended. Any public offering of securities to be made in the United States will be made by means of a prospectus that may be obtained from Intercell AG and that will contain detailed information about the company and management, as well as financial statements.
end of announcement euro adhoc 03.05.2005 08:00:45
Further inquiry note:
Mag. Katharina Wieser
Head of Corporate Communications
Tel. +43 1 20620-303
Börsen: Wiener Börse AG / official market