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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