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

On September 12, 2024 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, reported that the first patient has received BRC-001, an experimental supportive care therapy for breast cancer patients (Press release, City of Hope, SEP 12, 2024, View Source [SID1234646543]). 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.

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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.

"Cannabis-derived therapeutics are one of the most promising treatments to address underserved pain conditions. BRC has developed a proprietary therapy with unique properties to address joint pain in breast cancer patients taking aromatase inhibitors. We look forward to providing a therapy for these patients that allows them to complete a full course of treatment," said George Hodgin, CEO and founder of BRC, the industry leader in federally compliant cannabinoid therapeutics development.

"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."