Biosceptre, the oncology company developing antibody products that target the nf-P2X7 receptor, announced positive results from its Phase 1 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 1 trial, conducted in the US, was an open-label, single-arm, multicenter 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 localized 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 program for BCC, a form of cancer that results in between two and three million new cases in the US each year. This therapy has the potential in many cases to replace expensive, and often disfiguring, surgery.”
Date: July 23, 2014
Filed Under: Drug Discovery