CAMBRIDGE, England--(BUSINESS WIRE)--Biosceptre, the oncology company developing antibody products that target the nf-P2X7 receptor, announces positive results from its Phase I trial to assess the safety and tolerability of BIL-010t (formerly known as BSCT (Anti-nf-P2X7) 10% Ointment), a topically administered, highly purified sheep antibody therapy, to treat Basal Cell Carcinoma (BCC).
The Phase I trial, conducted in the US, was an open-label, single-arm, multicentre study, to assess safety, tolerability, and levels of anti-drug antibodies in the patients' serum. The study enrolled 21 male and female patients, with a BCC lesion histologically confirmed within the previous four weeks, who self-applied the BIL-010t ointment for 28 days.
The results showed that BIL-010t was both safe and well tolerated, with very high levels of patient compliance. The only reported side effect, associated with treatment, was mild to moderate localised skin reactions. Levels of BIL-010t were generally undetectable in patients' blood serum, and gave no evidence of immunogenicity in the majority of patients.
Although efficacy was not a prescribed endpoint of the trial, it was noted that 65% of patients (13 out of 20) who completed the study had decreases in the size of their BCC lesions. The reductions ranged from 10% to 56% reduction in the size of the BCC during the course of treatment.
“The results from this trial are extremely encouraging for the potential of nf-P2X7 as an entirely new target to treat cancer,” said Gavin Currie, CEO of Biosceptre. “BIL-010t is our lead topical programme for BCC, a form of cancer that results in between 2 and 3 million new cases in the US each year. This therapy has the potential in many cases to replace expensive, and often disfiguring, surgery.”
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About Biosceptre www.biosceptre.com
Biosceptre has identified a pan-cancer target, present in many cancer types, and importantly not found in healthy tissue. Early research and initial evidence suggest that drugs directed at the nf-P2X7 target have the potential to redefine cancer therapy. To date, Biosceptre has completed a Phase I topical study of BIL -010t, in the US, and is starting Phase I development of its systemic product BIL-221s. The Company has raised AUD33m and will be raising further capital through both existing and new investors. Biosceptre has a rigorous, international patent portfolio extending to 2032, providing broad protection of the target and specific protection of antibody products. The Company is developing therapeutics and diagnostics to bind nf-P2X7, with the core of product development in topical and systemic cancer drugs. Biosceptreis also developing an immuno-oncology vaccine, through an existing collaboration, and is in discussions with developmental partners to develop diagnostic and imaging technologies to detect and monitor cancer. Biosceptre is supported by a world-class scientific advisory board, the members of which have been central in the development of numerous, highly successful, biotechnology companies and products. The Company has the team, capital, and plan to create substantial value from this unique, patent-protected, technology. The business is headquartered in Cambridge, UK with additional research facilities in Sydney, Australia.
Most cells in the body utilise the mechanism of apoptosis (programmed cell death) to self-destruct when functionality is lost, genetic errors occur, or simply with age. Alterations in the mechanisms associated with cell death, including apoptosis, are associated with the development of cancer. The P2X7 receptor, known as a purinergic receptor because it is activated by ATP, is a key receptor involved in cell death mechanisms and functions such as proliferation and migration. Alterations in this receptor and its function are believed to be involved in the formation and maintenance of a variety of different types of cancers.
Biosceptre’s technology is centered on P2X7, specifically nf-P2X7, a form of the receptor in which a critical function, the formation of a large transmembrane pore on prolonged activation, has been lost. This loss in function is important in mediating key aspects of the receptors involvement in the transition of cells to a cancerous state.