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OncoVEXGM-CSF

Melanoma

A 50 patient Phase II trial testing OncoVEXGM-CSF as stand alone therapy in patients with un-resectable stage IIIc and stage IV metastatic melanoma has generated ongoing and durable overall Objective Responses in multiple patients. The Objective Responses include multiple complete responses where patients progressing with metastatic disease on enrolment have been declared disease free following therapy. The full detailed Phase II results will be presented at ASCO on 1st June. An SPA to govern a Phase III study with a durable response primary endpoint will be submitted to the FDA in the first quarter of 2008. We expect to commence this Phase III study in the first quarter of 2009 and be in a position to report interim efficacy and safety data in first half of 2010 with a potential BLA filing later that year. The study is likely to involve some 360 patients. .

There were 7,700 deaths attributable to melanoma in the United States in 2005, according to the American Cancer Society and the incidence of the disease is rising. Prevalence of stage IV and stage III disease is 120,000 with median survival of 6 months to two years.

Head & Neck cancer

The Company has completed a Phase I/II study in the first line treatment of head & neck cancer in combination with chemo radiation.  It was observed that there was a clear correlation between the dose of OncoVEX used and the rate of complete pathological response at surgery.  No patient receiving treatment with OncoVEX has recurred locally in the head & neck region to date. The Company intends to meet with the FDA in the second half of 2008 to seek agreement on the design of a second pivotal Phase III clinical trial to be governed by a SPA in recurrent head & neck cancer. Only 50% of patients with recurrent head & neck cancer survive one year, even when treated with aggressive multi drug chemotherapy.

Pancreatic and Colo-rectal cancer

We are also currently concluding a dose escalating Phase I study in pancreatic cancer where local responses have been observed after titrating up to an efficacious dose level. Further, we expect to commence a Phase I/II study in metastatic colo-rectal cancer affecting the liver in the fourth quarter of 2008.  Approximately 75% of pancreatic cancer tumors are inoperable at the time of diagnosis and, even following chemotherapy and radiation, one-year survival rates are less than 50% and five-year survival rates are less than 5%. Furthermore, in approximately 25% of patients with metastatic colon cancer, metastases are confined to the liver. These liver tumors generally cannot be surgically removed, and treatment with other therapy (normally chemotherapy) generally has a limited impact on survival. Improved control of these liver metastases would therefore be expected to directly impact survival rates.

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