A Phase 1 clinical trial demonstrates nfP2X7 targeted antibodies provide a novel, safe and tolerable topical therapy for BCC

Abstract

Background

Expression of P2X₇, an ATP gated calcium channel, increases cancer cell proliferation and invasiveness. A variant of P2X₇ (termed nfP2X₇), in which a normally hidden epitope (E200) is exposed for antibody binding, is observed in a variety of different cancers.

Objectives

To investigate the safety, tolerability and pharmacokinetics and assess indicative efficacy of a novel antibody ointment as a therapeutic for BCC.

Methods

An open label, Phase 1 clinical trial was undertaken at 3 dermatology clinics to evaluate the safety and tolerability of topical administration of an ointment containing 10% sheep polyclonal anti-nfP2X₇ antibodies (BIL010t) to primary BCC lesions twice daily for 28 days. Twenty one patients with primary BCC lesions at least 0.5cm² in area and less than 2.0cm in diameter were enrolled. The primary endpoints were safety, tolerability and pharmacokinetics (PK).Change in lesion size after treatment was determined and histology was performed on pre-treatment and End of Treatment (EOT) biopsies.

Results

Compliance was very high, with treatment being well-tolerated. The most common adverse events were treatment site erythema, pruritus, dryness and pain. There was no evidence of systemic penetration of the sheep antibody. Lesions were measured prior to and after 28 days treatment, with 65% of patients showing a reduction in lesion area, 20% no change and 15% an increase. Histopathology of post-treatment excision of lesion sites showed 8 patients with stable disease, 9 with partial response and 3 with complete response.

Conclusions

Antibodies against nfP2X₇ (BIL010t) provide a novel, safe and well tolerated treatment for BCC.

This article is protected by copyright. All rights reserved.

http://ift.tt/2k2Yu1g