Rare Disease Report

FDA Grants Marijuana-Based AML Treatment Orphan Drug Designation

JULY 26, 2017
Mathew Shanley
Medicanja Limited’s marijuana-based chrysoeriol, a drug intended to treat acute myeloid leukemia (AML), has recently been granted orphan drug designation by the U.S. Food and Drug Administration (FDA).
The official announcement was made at a press conference held by Henry Lowe, Ph.D., founder of Medicanja Ltd, at his wellness resort, Eden Gardens, in Kingston, Jamaica.
In AML, abnormal myeloblasts, or unipotent stem cells are produced by the bone marrow. Fatigue, recurrent infections and easy bruising are all typical symptoms of the cancer, and both the blood and bone marrow are affected. It is most frequently diagnosed in older adults.
Lowe first presented his research findings at the 2017 Global Health Catalyst Summit at Harvard Medical School in April. The drug was developed by his Maryland-based company, Flabocure Biotech LLC. Per a report from Global Voices, despite the potential payday that selling the drug to “big pharma” could earn him, he hopes to make enough money to simply continue his research and prep the retail market within the next 3 years.
Jamaican Prime Minister Andrew Holmes and Technology Minister Dr Andrew Wheatley were both in attendance for the press conference, but Holmes was sure to err on the side of caution while congratulating Lowe “because cannabis and the (medication) that could potentially come from it are still not recognized in many countries, and some countries still consider it illegal”.
Lowe has been using the time after the orphan drug designation to call for assistance in funding the research and development of chrysoeriol.
Lowe has not yet specified how chrysieriol helps AML patients, nor has he produced any preclinical or clinical data to support the drug’s potential use in AML patients.
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