I couldnt see the auto announcment. So I am putting it here:14...

I couldnt see the auto announcment. So I am putting it here:

14 February 2011
ASX Code: VHL
VIRAX ANNOUNCES EXCLUSIVE LICENSE WITH TRANSGENE FOR NOVEL SKIN CANCER IMMUNOTHERAPEUTIC TREATMENT

Key Points
?Virax and Transgene have entered into an exclusive Licensing Agreement for Virax to develop TG1042 skin cancer treatment product
?The worldwide Licensing Agreement is a major potential opportunity for Virax in the Australian and global market for the treatment of skin cancer
?Virax plans to move rapidly to a Clinical Trial with TG1042 in 2011
?Trials to be conducted in Australia to take advantage of world-leading skin cancer trial resources


Australian bio-pharmaceutical company Virax Holdings Limited (ASX:VHL) is pleased to announce that it has signed a worldwide exclusive License Agreement with leading French biopharmaceutical company Transgene (Eurolist Paris: FR0005175080) for Virax to develop Transgene?s TG1042 a clinical-stage skin cancer immunotherapy product.
Virax plans to now move rapidly into Phase I/IIa Clinical Trials for TG1042 in 2011 (subject to receiving the necessary regulatory approvals). The trials will be conducted in Australia in order to take advantage of the country?s world-leading skin cancer trial resources.
Transgene has previously conducted Phase II trials with TG1042 in patients with cutaneous B-cell lymphoma, a rare form of skin cancer. These trials showed TG1042 to be safe and well-tolerated and also showed very promising biological activity against the tumours. The positive finding of biologic activity in this orphan indication is particularly encouraging, as Virax plans to conduct its clinical trials in the much-larger Basal Cell Carcinoma (BCC) market. Specifically, Virax will target in patients with nodular BCC in its trials.
Virax sees a major protential market for TG1042 is as an alternative to surgery, or as an adjunct treatment in conjunction with surgery to minimise the chance of recurrence.
The principle commercial terms of the License Agreement for TG1042 under which Virax has acquired rights to TG1042 include the following:

?Global licence;
?Right to Sub-licence;
?Milestone payment to be paid to Transgene on first product approval;
?Royalty to be paid to Transgene on sales of TG1042 by Virax;
?Portion of Virax net receipts from sub-licensing to be paid to Transgene;
?No upfront license fee;

Under the Agreement, Transgene will assist Virax with technology transfer in order to facilitate the clinical trials process and will also provide an appropriate amount of clinical grade TG1042 for the planned clinical trials to be conducted in Australia. This is an important feature of the License Agreement and will enable Virax to pursue its aggressive clinical development plan for TG1042.
Virax will shortly begin the process of raising capital to fund the clinical trials in Australia. Virax also plans to enhance the efficiency of the trial funding process by accessing Australian Government programs that reward investment in novel research and development through tax credit incentives.
Virax CEO Dr Larry Ward said, ? Virax believes TG1042 is an exciting opportunity that fits perfectly the criteria we were seeking for an in-licensed product. It is an immunotherapeutic in a market that is large, growing and in need of new approaches to treatment. Skin cancer is an area especially top of mind for Australians. TG1042 is a clinical stage product that has already shown efficacy in another skin cancer indication. The availability of TG1042 that has been manufactured and tested allows us to move rapidly into the clinic.?
The program represents a major potential opportunity in the Australian and Global market. In Australia, non-melanoma skin cancers such as BCC occur three times more frequently than all other cancers combined. This already high incidence is expected to increase as the population ages further. Nodular BCC is a common form of BCC. Other regions with high incidence of BCC are USA, UK, Europe and Scandinavia.
Virax has assembled a panel of Australian skin cancer experts to review the Company?s plans for TG1042 and advise on the most appropriate clinical development program for this novel therapeutic.
Professor Rod Sinclair from the Department of Dermatology at Saint Vincent?s Hospital in Melbourne, commented, ?Nodular BCC occur predominantly on the head and neck. Of these about one quarter can be classified as difficult surgeries due to their size or anatomical location (e.g. close to eyelids). Surgery on the face may produce a scar that is cosmetically disfiguring. There is a clear need for alternative treatments such as immunotherapy for these difficult surgeries?
The TG1042 project builds on the technical expertise within Virax, in that it will utilise live viral vectors and cytokines to modulate the immune response against cancer cells. Virax has considerable experience in the development of such novel therapeutics through previous trials it has conducted in Australia with its VIR201 immunotherapeutic vaccine for the treatment of HIV/AIDS,. This regulatory and development experience will be helpful in the development of TG1042.

Skin Cancer Facts and Figures from Cancer Council Australia:
1.Skin cancers account for up to 80% of newly diagnosed cancers
2.Two in three Australians will be diagnosed with skin cancer by age 70
3.Skin cancer accounts for over 1 Million GP consultations each year in Australia
4.Nearly 450,000 people are treated for one or more non-melanoma skin cancers each year
5.Australia has one of the highest incidences of skin cancer in the world, nearly 4 times the incidence in the US and Western Europe
6.Skin cancer is the most expensive cancer in Australia

About TG1042 skin cancer immunotherapeutic product
TG1042 is an adenoviral vector expressing interferon-gamma. It has been tested previously in humans in skin cancer indications for the treatment of cutaneous lymphomas (via intratumoral injection), where it has shown highly promising results in Phase I and Phase II Clinical Trials.
In Phase I Trials, patients with advanced cutaneous T-cell lymphoma (CTCL) and multi-lesional cutaneous B-cell lymphoma (CBCL), treatment with TG1042 induced a high overall response rate of local clinical responses.
In Phase II Clinical Trial of Intra-lesional administration of TG1042 (Adenovirus-interferon-gamma), patients with relapsing primary cutaneous B-cell lymphomas, the primary endpoint was met in the first step of the Phase II trial as measured by overall response rate.
This treatment was highly promising and on this basis was awarded Orphan Drug status by the European medical regulatory body, European Medicines Agency (EMA) for the treatment of Cutaneous T cell Lymphomas. In addition, the prior human testing of the product has significantly lowered the technical risk of the project in nodular BCC.
Skin cancers such as BCC and melanoma are huge problems in Australia. Australia is the premier location to conduct trials in BCC and melanoma, and the ability of Virax to run the trials in Australia is one of the strategic reasons underpinning the Transgene licence to Virax.