On January 25, 2024 GlycaNova AS, the Norwegian biotechnology company focused on structurally intact beta-glucans for human and animal health, reported that no serious or other adverse events have been reported to date in its pioneering placebo-controlled trial of LentinexHP, a proprietary immuno-modulatory beta-glucan, administered as a non-drug therapeutic supplement alongside chemotherapy in patients with late-stage colorectal cancer (Press release, GlycaNova, JAN 25, 2024, View Source;utm_medium=rss&utm_campaign=clinical-trial-update [SID1234639477]).
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LentinexHP is a novel beta-glucan derived from the shiitake mushroom and is produced by GlycaNova’s proprietary manufacturing process, which enables production of beta-glucans with high biological activity and high structural integrity, maintaining the triple helix structure found in nature.
The clinical trial of LentinexHP is approaching the halfway stage with 15 patients having now been treated out of a planned total of 36 patients. No serious, or other, adverse events have been reported to date, which was confirmed by an independent audit by a Clinical Research Associate (CRA). Also, there have been no deaths among the 15 patients, which include some on LentinexHP and some on placebo.
In addition, all patients who have completed the 12-week duration of the trial have elected to stay on the trial on LentinexHP during a 40-week follow-up period. Whilst data from the trial is still being collected, early indications are that patients on the trial have experienced an increase in energy, a reduction in fatigue and an overall improvement in the quality of life.
The trial is being conducted at the Specialised Hospital for Active Treatment in Oncology (SHATO) in Haskovo, Bulgaria, and is of a randomised, parallel group, placebo-controlled design. Recruitment of patients into the trial is ongoing, and the addition of a further clinical site in Bulgaria is being considered to increase the pace of enrolment.
The primary endpoint of the trial is quality of life of patients with stage 4 metastatic colorectal cancer and secondary endpoints include improved quality of life and overall survival after one year.
Patients on the trial are randomly assigned to receive either 2ml of LentinexHP, or placebo, taken orally, twice daily for 12 weeks. Quality of life questionnaires and other assessments are completed after six and 12 weeks. The primary endpoint of quality of life is assessed at week 12, and further secondary endpoints of quality of life are assessed at various times after 12 weeks. The secondary endpoint of overall survival will be measured after one year.
The rationale for conducting the trial is that the combination of a biologically active but non-toxic, non-drug therapeutic supplement, LentinexHP, brings the potential to reduce resistance to chemotherapy and to reduce toxicity to non-cancerous cells thereby improving patient outcomes. The Company has previously demonstrated1 that the mode of action of LentinexHP is to stimulate a number of immune system responses thereby augmenting the effects of chemotherapy.
Dr Bjørn Kristiansen, GlycaNova’s Founder and Chief Executive Officer, said:
"We are delighted to be approaching the halfway point in this pioneering clinical trial of LentinexHP, which is being given as a non-drug therapeutic supplement alongside chemotherapy in late-stage colorectal cancer. It is particularly encouraging that, with 15 patients having been dosed in the study, that there have been no serious or other adverse events and that there have been no patient deaths during the trial.
"Early indications are that patients are experiencing an increase in energy, a reduction in fatigue and an overall improvement in the quality of life. Enrolment into the trial is ongoing, and we look forward to the results of the trial in due course."