PREVENTION OF TOXICITIES INDUCED BY TAXANES

Taxanes are chemotherapeutic agents used to treat various cancers. Taxanes are some of the most widely used chemotherapeutic agents and include paclitaxel, docetaxel, and cabazitaxel among others. Taxanes disrupt microtubule formation thereby preventing mitosis in rapidly growing cells. These actions create enormous oxidative stress and damage in both normal and cancerous cells.

Toxicities associated with taxanes, such as paclitaxel, include myelosuppression (low blood cell count), myalgia (muscle soreness), arthralgia (joint pain), peripheral neuropathy, mouth sores, hypersensitivity, nausea, vomiting, alopecia (hair loss), secondary malignancy (cancer), and many more. Furthermore, these side effects are often dose-limiting requiring a reduction in subsequent chemotherapy that may impact the overall success of the cancer treatment regimen.

Matrix Biomed, Inc.’s development program is directed to providing relief from toxicities associated with all taxanes. Specifically, Matrix Biomed, Inc. is  in the final development stages of clinical trials for the most widely used taxane, paclitaxel.

Matrix Biomed, Inc. is in the final stages of protocol development directed to the prevention of taxane-induced toxicities such as neuropathy. This protocol follows the framework of the mucositis protocol and treatment regimen giving Matrix Biomed, Inc. high confidence that the FDA will approve this study. Additional endpoints will be directed to the prevention and reduction of neutropenia and myelosuppression. MBM-02 has been shown to ameliorate and prevent mechanical hyperalgesia in a model of chemotherapy-induced neuropathic pain.

1. Objective: Prevention of Paclitaxel Induced Toxicities
2. Stage: Phase IIb
3. Study Population: Patients with stage 1-3 breast cancer receiving 12 week paclitaxel treatment
4. Number of Patients: 120 patients (1:1 Randomization; Tempol capsule v Placebo)

1. 1. Primary Endpoint: Reduction in neuropathy severity as measured by the modified Total Neuropathy Score.

1. Secondary Endpoints:
   1. Reduction in the incidence of premature chemotherapy discontinuation due to peripheral neuropathy by treatment group
   2. Reduction in the degree of peripheral sensory neuropathy in the two arms based on CTCAE v 5.0 grading
   3. Attenuation of the decrease in sensory nerve action potential on nerve conduction tests before and at the end of taxane-based chemotherapy
   4. Reduction in the incidence of grade 3 or 4 neutropenia as measured by the change in absolute neutrophil count