First patient received BRC-001, a cannabinoid therapeutic, in a clinical trial investigating supportive care in breast cancer at City of Hope.
City of Hope and Biopharmaceutical Research Company announce first patient has received BRC-001, a first-in-class cannabinoid therapeutic, in a clinical trial investigating supportive care in breast cancer
Researchers will evaluate whether the cannabinoid therapeutic candidate can address joint pain resulting from cancer treatment using aromatase inhibitors
This side effect has caused many breast cancer patients to discontinue treatment
LOS ANGELES and MONTEREY, Calif. — City of Hope®, one of the largest cancer research and treatment organizations in the United States, and Biopharmaceutical Research Company (BRC), a specialty pharmaceutical company developing proprietary cannabinoid therapeutics, announced today that the first patient has received BRC-001, an experimental supportive care therapy for breast cancer patients. City of Hope researchers are evaluating whether this cannabinoid therapeutic candidate could address joint pain (arthralgia) that is often a side effect of aromatase inhibitors, a type of hormone therapy used to treat postmenopausal women with breast cancer.
Aromatase inhibitors such as letrozole, anastrozole or exemestane are prescribed as standard of care for postmenopausal women with estrogen-receptor positive breast cancer to decrease breast cancer recurrence and mortality. About half of patients who take aromatase inhibitors experience joint pain, and many of these patients report severe symptoms. A significant number of patients discontinue cancer treatment due to this side effect. Currently, there is no approved treatment for aromatase inhibitor-induced arthralgia (AIIA). Patients often use over-the-counter, anti-inflammatory medications and other treatment options with limited efficacy for short-term pain management.
"This research to alleviate or eliminate side effects, such as joint pain, is part of City of Hope’s commitment to provide compassionate, individualized care,” said Lisa Yee, M.D., City of Hope professor of breast surgery and lead investigator of the trial. “We hope this work will yield innovative, FDA-approved therapies to help patients complete their lifesaving treatments.”
The clinical trial entitled “High Cannabidiol (CBD) Standardized Extract for Aromatase Inhibitor-Induced Arthralgia – A randomized controlled double blind clinical trial” is a randomized, placebo-controlled study at City of Hope’s Los Angeles cancer center. It is designed to assess the safety, tolerability and efficacy of a botanically derived proprietary formulation developed by BRC (BRC-001) when taken orally to address the symptoms of AIIA.
Yuman Fong, M.D., Sangiacomo Family Chair in Surgical Oncology at City of Hope, added, “Cannabis-derived medicines hold promise in alleviating symptoms of cancer and cancer therapy. They are potentially alternatives to opiates for pain relief, and alternatives to benzodiazepines for relief of anxiety and insomnia. We look forward to working with BRC in conducting trials to bring these medicines forward to help patients suffering from cancer.”