On the 21st of February Biosceptre’s proposed Phase I clinical trial for BIL06v (anti-cancer vaccine) was granted conditional approval by the Bellberry Ethics committee. Biosceptre is now proceeding to take BIL06v into a Phase I trial in late Q2 or early Q3 2018.
Biosceptre has high confidence in the safety of BIL06v, in part as a result of pre-clinical studies and compassionate access patients treated in Australia under the TGA’s Special Access Scheme.
The planned clinical trial will recruit between 20 and 30 patients from a basket of late stage cancers and seeks to confirm safety, tolerability and immunogenicity of BIL06v. The planned clinical trial will also seek to identify early indications of efficacy in humans.
CEO Gavin Currie said “Having recently closed entry to our Series A fund raising round, we are pleased that this fully funded clinical trial, building on significant preclinical data, has been conditionally approved. We consider that a successful clinical trial, our first for a systemic therapeutic product targeting nfP2X7, will provide further validation of nfP2X7. We are hopeful for first patient recruitment in Q2 2018.”