PREVENTION OF TOXICITIES INDUCED BY ANTHRACYCLINES

Anthracycline drugs are chemotherapeutic agents used to treat various cancers. Anthracyclines are some of the most widely used chemotherapeutic agents and include doxorubicin, epirubicin, daunorubicin, and idarubicin among others. Anthracyclines intercalate between DNA/RNA base pairs inhibit topoisomerase II thereby preventing replication of DNA and inhibiting rapidly growing cells. These actions create enormous oxidative stress and damage in both normal and cancerous cells.

Toxicities associated with anthracycline agents, such as doxorubicin, include neutropenia (low neutrophil count), anemia (low red blood cells), leukopenia (low white blood cells), pruritus (itchy skin), stomatitis (mouth inflammation), thrombocytopenia (low platelets), cardiotoxicity (damage to the heart), myelosuppression (low blood cell count), reduction in brain function and size, 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 anthracyclines. Specifically, Matrix Biomed, Inc.  is currently developing clinical trials for the most widely used anthracycline, doxorubicin.

Matrix Biomed, Inc. is finalizing a protocol for submission to the FDA for the prevention of anthracycline-induced cardiotoxicity in end stage breast cancer patients. Additional endpoints will be directed to the prevention and reduction of neutropenia and myelosuppression. TEMPOL has been shown to prevent and reduce doxorubicin-induced cardiotoxicity.

1. Objective: Prevention of Doxorubicin Induced Toxicities
2. Stage: Phase IIb
3. Study Population: Women with Breast Cancer Receiving Doxorubicin Treatment
4. Number of Patients: 120 (1:1 randomization Tempol capsules v Placebo)
5. Primary Endpoint: Reduction in Doxorubicin induced cardiotoxicity (damage to the heart)
6. Secondary Endpoints:
   1. Attenuation of the decrease in neutrophil count (white blood cell)
   2. Attenuation of the reduction in brain size and function

Noteworthy: The only approved compounds to prevent doxorubicin induced cardiotoxicity have substantial side effects and are limited to higher cumulative doxorubicin dose regimens. TEMPOL is well tolerated at the anticipated clinical dose for preventing doxorubicin induced toxicities. This study is designed to support FDA Breakthrough Therapy and Fast-Track Designations.