OXFORD BIOMEDICA GAINS FDA APPROVAL
FOR A PHASE II TRIAL OF TROVAX(R) IN RENAL CANCER
- Patient Recruitment to Commence Q3 2004-
Oxford, UK: 29 April 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(R), the Company's proprietary cancer vaccine, in patients with metastatic
renal cancer.
TroVax(R) 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(R) may halt or delay the progression of metastases so
increasing survival beyond the estimated median of 13 months. Using TroVax(R) 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(R) 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(R) 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(R)
with an immune stimulator such as IL2." |
