Regulatory clearance for start of patient recruitment in 120-patient Phase II trial of TroVax in patients with late-stage breast cancer
Oxford BioMedica, a gene therapy company, announces that the Southwest Oncology Group (Swog), a US clinical trials cooperative group, has received regulatory clearance to commence a Phase II trial of Oxford BioMedica's cancer immunotherapy, TroVax, in patients with late-stage breast cancer.
The US National Cancer Institute is sponsoring the trial and is responsible for the principal costs.
In June 2006, Swog submitted the trial plan to the US Food and Drug Administration and no issues were raised by the FDA.
In August 2006, the study was submitted to the US Recombinant DNA Advisory Committee and was similarly accepted, which means that the trial can now commence.
The targeted population for this study will be late-stage (Stage III and IV) breast cancer patients who have received standard therapy and have either minimal residual disease or no evidence of disease.
These patients are at high risk of relapse.
The current published literature indicates a median progression-free survival of 18 to 22 months for this patient group.
Approximately 120 patients will be enrolled in this open-label trial.
Patients will receive monthly injections of TroVax for three months, followed by booster immunisations at six, nine and 12 months.
Key endpoints will include immunological response rates to the 5T4 tumour antigen and progression-free survival versus historical controls.
Swog, which is responsible for all aspects of the trial, could commence patient enrolment before the end of 2006 in centres in the USA.
The trial is expected to complete in approximately two to three years.
Should this trial prove successful, Swog may conduct a Phase III trial in the same setting.
This is the first trial of Oxford BioMedica's cancer immunotherapy, TroVax, in patients with breast cancer.
The 5T4 tumour antigen, which is targeted by TroVax, is broadly distributed across most solid tumours.
Previous studies have shown that high levels of the 5T4 tumour antigen are present on over 80% of breast cancer cases.
To date, approximately 150 patients have been treated with TroVax in ten clinical trials in colorectal, renal and prostate cancer.
Oxford BioMedica plans to start a Phase III trial (TRIST) in renal cell carcinoma in the second half of 2006.
Commenting on the progress of Swog towards starting the Phase II trial in breast cancer, Oxford BioMedica's chief medical officer Mike McDonald said: "We are delighted that the Southwest Oncology Group is committed to evaluate TroVax as a potential treatment for breast cancer".
"Given what we know of the product's safety profile and the anti-cancer immune response that it stimulates, we are hopeful that TroVax can delay relapse of disease in this population of advanced-stage patients." +++ Debbie King writes: I was wondering where we stand with the Trovax.
And how soon this will be rolled out to all the breast cancer patients.
Please let me know this would give so much hope to me and others with breast cancer. Thanks Debbie King
