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Intercell AG Announces First Subject Enrolled in a Phase II Trial for the Further Development of Its Investigational Vaccine Enhancement Patch to Improve Pandemic Influenza Prevention in Collaboration With U.S. Department of Health and Human Services (HHS

Posted on: Thursday, 28 May 2009, 13:40 CDT

- Phase II clinical trial investigating the effectiveness of Intercell's Vaccine Enhancement (VE) Patch in combination with an injectable H5N1 pandemic influenza vaccine started today in the U.S.

- The study is fully funded by HHS - this is the second study conducted under a 5 year USD 128 m contract with the HHS

- Intercell's VE Patch may reduce the dosage and improve protection against an H5N1 pandemic influenza outbreak with only a single dose vaccine application

VIENNA and GAITHERSBURG, Md., May 28 /PRNewswire/ -- Intercell AG (VSE: ICLL) today announced that it has advanced its efforts to develop its VE Patch to improve prevention of H5N1 pandemic influenza with the start of a Phase II clinical trial. The randomized and blinded study aims to determine the optimal dosage of both Intercell's VE Patch and the H5N1 influenza vaccine injected concomitantly, when combined with each other in a single dose regimen. The trial will be conducted in the U.S. and is expected to enroll 500 subjects at six study sites.

"The commencement of this Phase II study represents an important milestone in the clinical development of our VE Patch technology and in the partnership with HHS for use of our technology in providing potentially improved Pandemic Influenza vaccines," stated Thomas Lingelbach, COO of Intercell AG and CEO of Intercell USA. "The recent H1N1 influenza situation certainly highlights again the important global public health need in this arena. If we achieve our goal to achieve full protection with only a single dose plus patch this means an enormous logistical advantage making PanFlu immunization feasible."

The H5N1 pandemic influenza vaccine tested in the study comprises Intercell's VE Patch and an injectable H5N1 influenza vaccine manufactured by Solvay Biologicals, B.V. (Netherlands).

In 2008 Intercell announced the results of a first clinical trial where the VE Patch was combined with an injectable H5N1 influenza vaccine, also manufactured by Solvay Biologicals B.V. The data revealed that a single 45-microgram dose of the H5N1 influenza vaccine, when administered with the Intercell VE Patch containing 50-microgram LT adjuvant, was sufficient to provide an immune response seen to be protective in 73% of the vaccines. This was a statistically significant improvement when compared to the subjects receiving the H5N1 influenza vaccine alone. Thus this was the first time that a single dose of H5N1 pandemic influenza vaccine met the level of protection suggested in U.S. Food and Drug Administration guidance that a pandemic vaccine needs to achieve immune response levels in at least 70% of the vaccine recipients in order to be considered protective.

About Pandemic Influenza

Three major influenza pandemics have occurred in the 20th century leading to the death of more than 50 million people globally. By U.S. government estimates, pandemic influenza has a greater potential to cause deaths and illnesses than virtually any other natural health threat.

About Intercell's Vaccine Enhancement Patch

Intercell believes that its VE Patch when applied in conjunction with an injectable vaccine has the potential for the development of improved vaccine products. Preclinical studies with different vaccines and the Phase I/II clinical study results using the VE Patch with an injectable H5N1 Influenza vaccine suggest that this strategy may be used for other injectable vaccines which are already approved or in development where improved immunogenicity, decreased antigen doses, or fewer immunization visits are desired.

About Intercell AG

Intercell AG is an innovative biotechnology company that develops novel vaccines for the prevention and treatment of infectious diseases with substantial unmet medical needs. Intercell's vaccine to prevent Japanese Encephalitis is the Company's first product on the market.

The Company's technology platforms include an antigen-discovery system, adjuvants and a novel patch-based delivery system (Vaccine Patch, Vaccine Enhancement Patch). Based on these technologies, Intercell has strategic partnerships with a number of global pharmaceutical companies, including Novartis, Merck & Co., Inc., Wyeth, and Sanofi Pasteur.

The Company's pipeline includes a Travelers' Diarrhea Vaccine Patch (Phase II concluded), a Pseudomonas vaccine candidate (Phase II), a Vaccine Enhancement Patch to prevent Pandemic Influenza in combination with an injected vaccine, a vaccine program for S. aureus, which is being developed with Merck & Co., Inc. (Phase II/III), as well as a vaccine candidate for Pneumococcus (Phase I). In addition, three other products focused on infectious diseases are in pre-clinical development.

Intercell is listed on the Vienna stock exchange under the symbol "ICLL" (U.S. level one ADR symbol "INRLY").

For more information, please visit: www.intercell.com

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.

SOURCE Intercell AG

Source: PR Newswire

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