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.
top
|
