OncoVEXGM-CSF

Melanoma

The OPTiM (OncoVEX Pivotal Trial in Melanoma) Phase 3 study with OncoVEXGM-CSF in previously treated patients with Stage III and Stage IV melanoma has initiated. The study has commenced recruiting patients in the U.S. with sites in the United Kingdom and Germany due to open later in the year. Further details on this study can be found at www.oncovexgmcsf.com and at www.clinicaltrials.gov.

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 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. An SPA to govern a Phase III study with a durable response primary endpoint was agreed with the FDA in April 2008.

Updated survival data from the Phase II study in metastatic melanoma presented at the 2009 American Society of Clinical Oncology (ASCO) Annual Meeting, June 1, 2009. Abstract (number 9035) entitled "Phase II clinical trial with a second generation, GM-CSF encoding, oncolytic herpes virus in unresectable metastatic melanoma."

We expect to 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 middle of 2009 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.

Results presented in an abstract (number 6018) entitled, "Phase I/II dose escalation study of OncoVexGM-CSF and chemoradiotherapy (CRT) in untreated stage III/IV squamous cell cancer of the head and neck (SCCHN)" at the 2009 American Society of Clinical Oncology (ASCO) Annual Meeting, 1 June 2009.

Pancreatic and Colo-rectal cancer

In a dose escalating Phase I study in pancreatic cancer local responses were observed in all patients after titrating up to an efficacious dose level.  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%.

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