Clinical Trial to Investigate Cannabis Supportive Care for Breast Cancer

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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.

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“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.

“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.”

About City of Hope

City of Hope’s mission is to make hope a reality for all touched by cancer and diabetes. Founded in 1913, City of Hope has grown into one of the largest and most advanced cancer research and treatment organizations in the U.S., and one of the leading research centers for diabetes and other life-threatening illnesses. City of Hope research has been the basis for numerous breakthrough cancer medicines, as well as human synthetic insulin and monoclonal antibodies. With an independent, National Cancer Institute-designated comprehensive cancer center that is ranked top 5 in the nation for cancer care by U.S. News & World Report at its core, City of Hope’s uniquely integrated model spans cancer care, research and development, academics and training, and a broad philanthropy program that powers its work. City of Hope’s growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and cancer treatment centers and outpatient facilities in the Atlanta, Chicago and Phoenix areas. City of Hope’s affiliated group of organizations includes Translational Genomics Research Institute and AccessHope.

About Biopharmaceutical Research Company

Biopharmaceutical Research Company (BRC) is a specialty pharmaceutical company focused on developing proprietary cannabinoid therapeutics to address high unmet medical needs. BRC’s therapeutics are polymodal and contain major and minor cannabinoids at strictly defined and proprietary ratios. The company is developing a pipeline of treatments addressing pain and neurological and inflammatory conditions. BRC is registered with the Drug Enforcement Administration and is based in Monterey, CA.

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