Virax Holdings Limited, (ASX: VHL), advises that Transgene SA of Strasbourg, France, reported that its therapeutic vaccine TG4010 showed promising preliminary Phase IIb data in advanced non-small cell lung cancer when used as an adjunct to first line chemotherapy. TG4010 uses Virax’s Co-X-Gene™ technology under the stated License Agreement between the Company and Transgene. Transgene said the trial confirmed the favourable safety profile of TG4010 when associated with chemotherapy and that based upon local evaluations, results are so far showing a positive trend in favour of the combination of TG4010 with the chemotherapy.

Virax’s CEO, Larry Ward, said “the data is encouraging. Transgene are making great progress with both this product and their therapeutic vaccine, TG4001, for the treatment of pathologies relating to human papilloma virus (HPV) infection that can lead to cervical cancer. The advancement of both Transgene products into late stage development exemplifies the intrinsic value of the Co-X-Gene™ technology intellectual property and the Transgene Sublicense. We look forward to the presentation by Transgene of the full trial data for TG4010 later in the year.”

The Transgene Press release is attached below.


About Virax
Virax, based in Melbourne, Australia, is a biopharmaceutical company engaged in the discovery and development of novel immunotherapeutic products for the treatment of chronic infectious diseases and cancer. The Company’s lead product, VIR201, an HIV/AIDS immunotherapeutic (therapeutic vaccine), recently cleared by the U.S. FDA to begin Phase II trials, has completed two successful clinical trials in Australia with additional international studies planned. The Company has also submitted an application to the South African regulatory authority (MCC) to conduct a Phase I/IIa trial of VIR201. Funding for the African trial has been contributed by a consortium of global and South African resource companies led by BHP Billiton.

In March 2007 Transgene (Eurolist Paris: FR0005175080) executed a Licence Agreement with the Company for access to Co-X-Gene™ technology for use in two of Transgene’s immunotherapeutic products. These are TG4001 – a treatment for pathologies relating to human papilloma virus (HPV) infection that can lead to cervical cancer - and TG4010 – a treatment for non-small cell lung cancer. This was reported to the ASX in the Company’s announcement of 13 March 2007 and is referred to as the “Transgene Sub-licence”. Both TG4001 and TG4010 are in advanced development with Phase III trials of TG4001 planned for 2008 and Phase IIb studies of TG4010 currently underway. Transgene has licensed TG4001 to the pharmaceutical company Roche for treatment of HPV related pathologies.

For further information contact:
Dr Larry Ward
CEO, Virax Holdings Limited
Melbourne, Australia
(03) 9854 6230

John Morrison
CFO, Virax Holdings Limited
Melbourne, Australia
(03) 9854 6230

TRANSGENE’S THERAPEUTIC VACCINE TG4010 SHOWS
PROMISING PRELIMINARY PHASE IIb DATA IN
ADVANCED NON-SMALL CELL LUNG CANCER

Strasbourg, France, January 10th, 2008 - Transgene (Euronext Paris: FR0005175080) announces promising preliminary data from the Phase IIb trial evaluating its therapeutic vaccine TG4010 (MVA-MUC1-IL2) as an adjunct to first line chemotherapy in patients with advanced non-small cell lung cancer (NSCLC).

This on-going trial is a randomized, open label and controlled study designed to assess the efficacy of TG4010 in combination with cisplatin and gemcitabine compared to the chemotherapy regimen alone. The trial completed the enrolment of 148 patients at the end of May 2007 and was conducted in 27 centres located in France, Poland, Germany, and Hungary. The patients had NSCLC expressing MUC1, either stage IIIB with effusion or stage IV, and had not received prior systemic treatment for their advanced disease. Half of the patients received the combination regimen (TG 4010 vaccine plus chemotherapy) and the other half of the patients received chemotherapy alone.

The trial confirmed the favourable safety profile of TG4010 when associated to chemotherapy: most adverse events observed so far were considered related to chemotherapy as well as to the underlying disease. Hematological toxicity was equivalent in both treatment groups. Most frequent adverse events related to TG4010 were injection site reactions and asthenia, which are classical vaccine associated reactions.

Based on the local evaluations performed at investigation centres, results so far are showing a positive trend in favour of the combination of TG4010 with the chemotherapy. These results nevertheless remain subject to a centralised review process that is presently on-going.

"We report today encouraging trends on the preliminary results of our Phase IIb trial with TG4010 in non-small cell lung cancer” said Philippe Archinard, Chief Executive Officer of Transgene. “We expect to present data during the second quarter of this year and final data by the fourth quarter of 2008.”

About TG4010 cancer vaccine
TG4010 (MVA-MUC1-IL2) uses the Modified Vaccinia Ankara virus vector, a poxvirus that combines distinguishing advantages for an optimized systemic vaccination:

• MVA is a highly attenuated strain which has been tested extensively in humans as a smallpox vaccine and is known to strongly stimulate the immune response to antigens.
• MUC1 is a major tumor-associated antigen that provides a viable target for vaccination.
  
• TG4010 expresses the entire MUC1 gene sequence and has the potential to generate an immune response to all antigenic epitopes of MUC1.
• The sequence coding for the cytokine Interleukin 2 (IL2) is included to help stimulate specific T-cell response.
  

About previous TG4010 clinical data
Non-controlled Phase II data are available at: http://www.transgene.fr/us/pdf/communique_presse/communiques_divers_2005/PR-US_17- 05-2005_ASCO_POUMON.pdf


About Transgene
Transgene is a France-based biopharmaceutical company dedicated to the development of therapeutic vaccines and immunotherapeutic products in oncology and infectious diseases. The company has one product which has completed Phase II trials (TG4001/R3484), two compounds in Phase II trials (TG4010 and TG1042) and one compound in Phase I studies (TG4040). Transgene has concluded a strategic partnership agreement with Roche for the development of its TG4001/R3484 therapeutic vaccine to treat HPV-mediated diseases. Transgene has bio-manufacturing capacities for viral-based vectors and technologies available for out-licensing. Additional information about Transgene is available on the Internet at www.transgene.fr.


Cautionary note regarding forward-looking statements
This press release contains forward-looking statements referring to the encouraging trends on preliminary results of one of Transgene’s therapeutic vaccine candidates. However, because these results are preliminary, are based on local evaluations performed at the clinical trial centres and are subject to an additional centralised review process by evaluation experts, there can be no certainty that they will be confirmed. This additional centralised review may lead to a different evaluation of the results, positive or negative. Clinical testing and successful product development depend on a variety of factors, including the timing and success of future patient enrolment and the risk of unanticipated adverse patient reactions. Results from future studies with more data may show less favourable outcomes than prior studies, and there is no certainty that product candidates will ever demonstrate adequate therapeutic efficacy or achieve regulatory approval or commercial use. For further information on the risks and uncertainties involved in the testing and development of Transgene’s product candidates, see Trangene’s Document de référence on file with the French Autorité des marchés financiers on its website at http://www.amf-france.org and Transgene’s website at http://www.transgene.fr .

Investor contacts:
Transgene
Philippe Poncet, Chief Financial Officer
Phone: + 33 3 88 27 91 21

Press contacts:
Capital MS&L
Mary Clark
Anna Mitchell
Phone: +44 20 7307 5330
anna.mitchell@capitalmsl.com