A cannabinoid-centric American biotechnology company is entering the next phase of a trial focusing on improving the quality of life for cancer patients.
Naples, Florida-based Enveric Biosciences has received approval from the Israeli Ministry of Health to begin Phase ½ of its triple combination cannabidiol (CBD) treatment for glioblastoma (GBM).
Glioblastoma and the Brain
The most common malignant brain tumor, GBM is a quick-spreading and aggressive type that starts in the brain and invades nearby tissue.
GBM risk factors include prior therapeutic radiation, hereditary cancer syndromes like Lynch syndrome, decreased susceptibility to allergy, and impaired immune response.
Left untreated, GBM can cause death in under six months.
Enveric lead asset EV101 investigates the safety and efficacy of synthetic CBD when administered by itself or together with clomiphene and temozolomide to patients with recurrent or progressive GBM.
Enveric is conducting the study at the Davidoff Institute of Oncology, Rabin Medical Center in Peta Tikva, Israel under Principal Investigator Dr. Tali Siegal.
“Glioblastoma is a highly aggressive form of cancer with a very poor overall survival rate, particularly for those with recurrent GBM, which is the target group for this study,” says Enveric CMO Robert Wilkins, M.D. “Our goal with this study is to enhance the existing treatment’s efficacy through adding CBD to create a new standard of care, potentially improving and extending glioblastoma patients’ quality of life.”
Glioblastoma and CBD
Phase 1 of Enveric’s GBM study focuses on determining the CBD-temozolomide combination’s maximum tolerated dose (MTD).
To rule out toxicity, up to 24 participating patients will also receive clomiphene.
When the MTD of CBD, clomiphene, and temozolomide are determined, Enveric will apply them to the trial’s Phase 2 to determine initial efficacy.
Enveric says it expects to recruit an additional 40 patients and randomize them into two open-label treatment arms.
Arm 1 will consist of patients treated with the MTD determined during the dose-finding phase for synthetic CBD oil with temozolomide.
Arm 2 will consist of patients treated with the MTD determined during the dose-finding stage for synthetic CBD oil with temozolomide and clomiphene.
Enveric says involved patients will continue treatments for up to 24 months from the start of the therapy unless unacceptable toxicities, patient consent withdrawal, or death occur.