REM-001: A Proprietary Late Stage Photodynamic Therapy (PDT) Platform
REM-001 is a second-generation photodynamic therapy (PDT) photosensitizer agent which has undergone late stage clinical development in previous clinical trials showing a complete response in approximately 80% of evaluable tumor sites.
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. Our 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.
Our development plan for REM-001 Therapy is focused on the treatment of rare or unmet cancer indications, particularly those where the tumor can be accessed with a light delivery fiber device, such as CMBC.
REM-001 has been granted orphan drug designations for the treatment of recurrent basal cell carcinoma nevus syndrome (BCCNS) and ovarian cancer. In addition, the FDA has granted a fast track designation for REM-001 in CMBC.