Date: 2012-10-10
Type of
information: Halting of the trial
phase: 2
Announcement: halting of the trial
Company: Oxford BioMedica (UK)
Product: TroVax® (MVA-5T4)
Action
mechanism:
- immunotherapy product/therapeutic vaccine. TroVax® is a therapeutic vaccine that stimulates the immune system to destroy cancerous cells expressing the 5T4 tumour antigen which is present on most solid tumours. The product comprises a modified vaccinia virus Ankara (MVA) vector, encoding the 5T4 antigen. Vaccinia viruses are commonly used as delivery systems for the development of antigen-specific vaccines.
Disease: progressive hormone refractory prostate cancer (HRPC)
Therapeutic
area: Cancer - Oncology
Country: USA
Trial
details:
Latest
news:
- Oxford BioMedica, a gene-based biopharmaceutical company, has announced that it plans to close the Phase II study in the United States (US) to assess the activity of TroVax® (MVA-5T4) in patients with progressive hormone refractory prostate cancer (HRPC). TroVax® continues to have an active Phase II development programme in other indications led by academic collaborators in the UK.
This US study has been initiated in September 2010. Since then, the prostate cancer treatment landscape in the US has changed with new products available and other clinical trials targeting the same indication. As such, competition for suitable patients with HRPC has been high and recruitment into the study has been much slower than originally anticipated with 26 patients recruited to date. Whilst early data from this study are encouraging, the Board has made a strategic decision to close the US trial in order to focus on investigator-led Phase II studies, currently in the UK.
Although the study will close prior to completion of patient recruitment, and therefore any unverified preliminary data should be interpreted with caution, initial data indicate:
A trend towards increased time to disease progression in patients who received TroVax® plus chemotherapy drug docetaxel versus those who received docetaxel alone;
Importantly, these data validate the observation that Oxford BioMedica’s pre-treatment biomarker can identify patients most likely to benefit from treatment with TroVax®:
- As with prior studies, HRPC patients with a favourable biomarker profile mounted stronger 5T4 immune responses; and
- Furthermore, the biomarker score was associated with the time to disease progression in patients treated with TroVax® plus docetaxel.
- Oxford BioMedica’s partners at Cardiff University has recently initiated a Phase II trial to assess the safety and immunological activity of TroVax® in patients with inoperable metastatic colorectal cancer . The Company expects two further investigator-led Phase II studies in mesothelioma and ovarian cancer to be initiated in the UK by academic collaborators in Q4 2012. Securing a development or financial partner for TroVax®’s future late-stage development remains a key strategic priority for the Company and discussions with interested parties are ongoing.
Is
general: Yes
