Biosceptre has high confidence in the safety of BIL03s, in part as a result of pre-clinical toxicology studies and compassionate access patients treated in Australia under the TGA's Special Access Scheme.
The planned clinical trial, approved by the committee on 5th of January, would recruit between 12 and 42 patients with a range of late stage cancers and seek in a Phase I clinical trial to confirm safety and tolerability of BIL03s and provide indications of efficacy in humans.
CEO Gavin Currie said, "We are pleased that this clinical trial, building on significant preclinical data, has been conditionally approved, and believe that a successful clinical trial, our first for a systemic therapeutic product targeting nfP2X7, would provide further validation of our oncology therapy target. We are now seeking partners and external funding to progress BIL03s into clinic."
About Biosceptre:
Biosceptre is a Cambridge, UK headquartered biotechnology company focused on developing next generation cancer treatments targeting nfP2X7. Biosceptre's product pipeline includes systemic antibody-based therapeutics and vaccines to treat a range of cancer types, as well as a topical product for skin cancers. With the phase I trial of the topical product now completed, Biosceptre will be seeking potential partners for development funding and licensing, and will re-enter the clinic in 2017. For more, visit www.biosceptre.com.
Media Contact
Daniel Barton
media@biosceptre.com
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