Ecofibre has reported positive results from studies testing CBD as a treatment for endometriosis and gynaecological cancers.
The ASX-listed firm’s Ananda Hemp division used organoid technology to obtain a collection of normal and damaged tissue samples and vaginal epithelial stem cells before treating them with different doses of Ananda CBD extract.
In endometriosis, it found the treatment eliminated damaged cells while preserving healthy tissues in a “significant” number of patients with a combination of vaginal cream and oral oil delivering the best outcomes. Results were seen within three to four weeks.
In endometrial and ovarian cancer, researchers found the extract, when combined as an adjunct, enabled a 20% decrease in the standard chemotherapy dose in humans and five times in organoid and patient-derived xenograph animal models.
In an update to investors, healthcare specialists and researchers, chief science officer Dr Alex Capano said endometriosis, which affects 11% of women in Australia, is associated with increased anxiety and decreased quality of life while costing billions of dollars in lost productivity every year.
She cited US research showing that 65% of patients suffering from the condition use opioids, rising to 84% at follow up.
“This is long-term opioid use and it’s really not the solution for endometriosis,” Capano said. “We need to do better with pain management, but we [also] need to do better with quality of life and disease management.”
Ananda Hemp is targeting the condition not only because of the number of women affected and the health and socioeconomic costs, but due to the lack of effective treatments currently available.
Capano said: “There are really not great treatment options outside of surgery, which is still controversial and doesn’t always work.
“From a commercialisation standpoint, endometriosis is prevalent so it’s not hard to recruit participants. There’s a serious need for safer and better therapies, and there’s not a lot of competition.”
The market is estimated to be worth around $4 billion by 2030.
More than 200 women have participated in the studies to date, which were led by Professor Pradeep Tanwar at the University of Newcastle’s Global Centre for Gynaecological Diseases.
The firm is planning to lodge a commercial Investigational New Drug application with the US Food and Drug Administration in the coming months. It will also start phase II clinical trials on endometriosis, with an eye on gynaecological cancers at the same time.
“As we’re doing that for endometriosis, we will be maturing the data and the IP for the oncology indications,” Capano said.
“Endometriosis, endometrial cancer and ovarian cancer are the top three indications that we’ve evaluated. We have the most supportive data and the IP to move forward with drug development in these.
“We need to show that proof of concept [for endometriosis] and then we can move on and pursue some of the more challenging indications.”
Capano said the path to approval was de-risked because of the firm’s use of organoids and their ability to be more predictive of human response.
It is yet to be confirmed whether the trials will take place in Australia, the US, or both.