Investigation of the Safety and Tolerability of BSCT (Anti-nf-P2X7) 10% Ointment

An Open-Label Phase 1 Investigation of the Safety and Tolerability of BSCT (Anti-nf-P2X7) 10% Ointment When Applied Twice Daily for 28 Days in Male and Female Patients With Basal Cell Carcinoma

This is a Phase 1, open-label, single-arm, multicenter study to assess the safety and tolerability of BSCT (anti-nf-P2X7) 10% Ointment in subjects with BCC.

The purpose of the trial was to determine the safety and tolerability of BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days in male and female patients with BCC; and to determine the steady-state pharmacokinetics (PK) of the active pharmaceutical ingredient (total sheep Immunoglobulin G [IgG]) when BSCT (anti-nf-P2X7) 10% Ointment is applied twice daily to BCC lesions. This was an open-label, single-arm, multicenter Phase 1 study that enrolled 21 BCC patients.

Inclusion Criteria:

• Male or female adults ≥ 18 years of age;
• One primary histologically confirmed BCC lesion, not located on the hand or foot, suitable for surgical excision, with a minimum area of 0.5 cm2 and a maximum diameter of 2.0 cm (histological diagnosis made no more than 4 weeks prior to the Screening visit.
• Willing to refrain from using non-approved lotions or creams on the BCC treatment site and surrounding area during the treatment period and from washing the treated area for at least 8 hours following each application of study medication;
• Ability to follow study instructions and likely to complete all study requirements;
• Written informed consent obtained, including consent for biopsy tissue to be examined and stored by the central dermatopathologist;
• Written consent to allow photographs of the BCC lesion to be used as part of the study data;
• For females of childbearing potential, a negative pregnancy test at Screening and use of an acceptable form of birth control.

Exclusion Criteria:

• Pregnant, lactating, or planning pregnancy during the study;
• Presence of known or suspected systemic cancer;
• Histological evidence of squamous cell carcinoma (SCC) or any tumor other than BCC in the biopsy specimen;
• Histological evidence of severe squamous metaplasia, infiltrative, desmoplastic, or micronodular growth patterns in the biopsy specimen;
• Evidence of dermatological disease or confounding skin condition within the 25-cm2 treatment area, eg, SCC, actinic keratosis, rosacea, psoriasis, atopic dermatitis, eczema, or xeroderma pigmentosa;
• Concurrent disease or treatment that suppresses the immune system;
• Chronic medical condition that in the judgment of the investigator would interfere with the performance of the study or would place the patient at undue risk;
• Known sensitivity to any of the ingredients in the study medication;
• Treatment with systemic chemotherapeutic agents (eg, methotrexate, paclitaxel) within the 6 months prior to the Baseline visit;
• Use of systemic retinoids within the 6 months prior to the Baseline visit;
• Treatment with systemic immunomodulators or immunosuppressants within the 6 months prior to the Baseline visit;
• Use of topical immunomodulators within 2 cm of the target treatment area within the 4 weeks prior to the Baseline visit;
• Treatment with topical agents for the treatment of BCC or actinic keratosis within 2 cm of the target treatment area within the 4 weeks prior to the Baseline visit:
• Treatment with liquid nitrogen, surgical excision or curettage within 2 cm of the target treatment area during the 4 weeks prior to the Baseline visit;
• Clinically significant abnormalities as noted in the screening ECG, physical examination, or laboratory test results;
• Evidence of current chronic alcohol or drug abuse which, in the investigator's opinion, might interfere with the subject's adherence to protocol requirements;
• Current enrollment in an investigational drug or device study or participation in such a study within 4 weeks of the Baseline visit;
• In the investigator's opinion, evidence of unwillingness, or inability to follow the restrictions of the protocol and complete the study.