Oxford BioMedica shares may have crashed after TroVax failed to reach its targets in a late-stage trial in renal cancer, but it is not all doom and gloom for the UK biotechnology firm.
The stock slumped last week after Oxford BioMedica revealed that the independent data safety monitoring board for the 733-patient Phase III TRIST study of TroVax in renal cancer has recommended that the trial should continue but that further vaccinations be discontinued, following its fourth interim review. The DSMB advised that TroVax administered according to the protocol will not meet the predefined primary efficacy endpoint, “but there is important scientific merit and more to be learned by additional follow-up of all patients.”
However, the Oncology Clinical Trials Office, part of Oxford University, says that it remains committed to the QUASAR V Phase III trial it is coordinating for TroVax in colorectal cancer. OCTO added that the DSMB’s stance on TRIST “does not impact on our enthusiasm to progress the QUASAR V TroVax study”.
It added that “from both a scientific and clinical perspective we feel that TroVax should be tested in the adjuvant setting of colorectal cancer and remain committed to the study”. It is expected to enrol approximately 3,000 patients and has been designed with a primary endpoint of three-year disease-free survival. The funding of QUASAR comes from a variety of sources, including the UK Medical Research Council and the Department of Health, though Oxford BioMedica and partner Sanofi-Aventis have yet to decide how to procced with the Trovax programme.
Analysts are also saying that the firm still has much to look forward to. Robin Davison at Edison Investment Research acknowledges that Oxford BioMedica has clearly suffered a major setback to TroVax, “which will, optimistically, delay approval by three years – to 2013 – in our view”.
He added that the company “also faces significant uncertainty until the reaction of Sanofi is known”. However, given the share price reaction, “which has predictably fallen to little above cash,” there is now “an attractive, albeit high-risk, recovery story built around salvaging some useful data from TRIST”. Mr Davison added that the firm can also focus accelerating development of the Parkinson’s disease treatment ProSavin.
