Oxford
BioMedica Gains FDA Approval
for a Phase II Trial of Trovax® in Renal Cancer
Patient
Recruitment to Commence Q3 2004
Oxford
BioMedica (LSE :OXB.L), the leading gene therapy company
announces today that the US Food & Drug Administration
(FDA) has approved an Investigational New Drug (IND) application
to evaluate TroVax®, the Company’s proprietary
cancer vaccine, in patients with metastatic renal cancer.
TroVax
will be tested in combination with the standard treatment
interleukin-2 (IL-2), an immune stimulator, in
patients whose median survival is approximately 13 months.
Safety and immunogenicity will be the primary goals, but
patients will be monitored for clinical benefit including
increased survival. The trial will be conducted at the
Columbia Presbyterian Medical Center in New York and patient
recruitment
is expected to start in Q3 2004. The study should be complete,
as far as the primary end-points are concerned, within
approximately twelve months of initiation.
There
were an estimated 31,900 new cases of renal cancer in the
US in 2003 (source: American
Cancer Society, Cancer
Facts and Figures for 2003). More than half of these patients
have metastatic disease (secondary cancer). After surgical
removal of the primary tumour, treatment with IL-2 has
been shown to have some benefit, suggesting that the tumours
may
be responsive to immunological strategies. The rationale
for this trial is that the immune response induced by TroVax
may halt or delay the progression of metastases so increasing
survival beyond the estimated median of 13 months. Using
TroVax in combination with IL-2 may enhance that response.
There
is a great need for additional therapies for renal cancer
as the prognosis for patients is poor with current
treatments. The regulatory strategy for the development
of TroVax will involve seeking fast track approval and
opening discussions about product registration if early
data are encouraging.
Commenting
on the approval Oxford BioMedica’s
Chief Executive, Professor Alan Kingsman said: "We
are delighted to be able to take TroVax into the USA in
an
indication that has real unmet medical need.
We
expect patient recruitment to be faster than we have seen
in previous trials and we are excited about testing TroVax
with an immune stimulator such as IL2."
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