REM-001 Therapy

Candidate & Indication Development Stage
Preclinical Phase 1 Phase 2 Phase 3 Market
REM-001 Cutaneous Metastatic Breast Cancer
Preclinical Phase
Phase 1 Phase
Phase 2 Phase
Phase 3 Phase
Market Phase
REM-001 Recurrent Basal Cell Carcinoma with Nevus Syndrome (BCNS) and Locally Advanced Basal Cell Carcinoma (laBCC)
Preclinical Phase
Phase 1 Phase
Phase 2 Phase
Phase 3 Phase
Market Phase
REM-001 Cutaneous Metastatic Cancers Other than CMBC (e.g., Lung, Ovarian and Colon)
Preclinical Phase
Phase 1 Phase
Phase 2 Phase
Phase 3 Phase
Market Phase

REM-001 Therapy consists of three parts, a laser light source, a light delivery device and the drug REM-001 (collectively, REM-001 Therapy). REM-001 is a second generation photosensitizer drug that has undergone late stage clinical development, and which we believe possesses multiple advantages over earlier generation PDT compounds. The lead indication for REM-001 Therapy is unresectable cutaneous metastatic breast cancer (CMBC), a disease that may affect individuals with advanced breast cancer and for which effective treatment options are limited. For this and similar cutaneous applications, the light delivery device is a simple and easy to use fiber optic wand that the physician employs to directly illuminate the tumor with light.

In four Phase 2 and/or Phase 3 clinical trials in CMBC patients, primarily targeting patients who had previously failed radiation therapy, REM-001 Therapy was able to reduce or eliminate a substantial number of the treated CMBC tumors. Specifically, our analysis of the data collected from these trials indicates that in approximately 80% of evaluable tumor sites treated with REM-001 Therapy, there was a complete response; meaning that follow-up clinical assessments indicated no visible evidence of the tumor remaining.

Indications

Our development plan for REM-001 Therapy is focused on the treatment of orphan cancer indications, particularly those where the tumor can be accessed with a light delivery fiber device, such as: