First patient dosed in clinical trial of LentinexHP in late-stage colorectal cancer
Pioneering placebo-controlled trial of a novel beta-glucan dietary supplement administered alongside chemotherapy
GlycaNova AS, the Norwegian biotechnology company focused on structurally intact beta-glucans for human and animal health, announces that the first patient has been dosed in a pioneering clinical trial of LentinexHP, a proprietary immuno-modulatory beta-glucan, administered as a food supplement alongside chemotherapy in patients with late-stage colorectal cancer.
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.
Beta-glucans have been widely studied in East Asia, where medicinal mushrooms have been used in traditional medicine for thousands of years. In 1985, a beta-glucan from shiitake mushrooms was approved in Japan as an adjuvant for stomach cancer therapy and beta-glucans have also been approved in China for treating multiple cancer types1.
The primary endpoint of the LentinexHP trial is quality of life of patients with stage 4 metastatic colorectal cancer and secondary endpoints include overall survival after one year. Colorectal cancer is the third most prevalent cancer worldwide, according to the International Agency for Research on Cancer2, and remains an area of high unmet need with limited treatment options.
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 of 36 patients. All patients are expected to be dosed by the autumn of this year and the final read out from the study is expected around the end of 2024.
Patients on the trial will be randomly assigned to receive either 2ml of LentinexHP, or placebo, taken orally, twice daily for 12 weeks. Quality of life questionnaires and other assessments will be completed after six and 12 weeks. The primary endpoint of quality of life will be assessed at week 12, and further secondary endpoints of quality of life will be 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 dietary 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 demonstrated3 that the mode of action of LentinexHP is to stimulate a number of immune system responses thereby augmenting the effects of chemotherapy.
GlycaNova selected stage 4 colorectal cancer for the trial owing to earlier studies showing activity of its beta-glucans against solid tumours including colorectal cancer cells and because of the poor outcomes and limited treatment options in this cancer type, which was associated with more than 935,000 deaths worldwide in 20204.
The regulatory pathway for LentinexHP, on the basis of positive results from the current clinical study, is expected to be relatively straightforward as LentinexHP is a dietary supplement, or potentially a medicinal food, rather than a pharmaceutical drug. The regulatory pathway will be confirmed once the results of the current trial have been received.
The Company’s strategy of advancing LentinexHP as a dietary supplement rather than as a prescription medicine is to accelerate the route to market of the product and to maximise access for patients.
Dr Stoil Boychev, Oncologist, Cancer Specialist at SHATO and Principal Investigator of the trial, said:
“I am hopeful that LentinexHP will improve the condition of our patients and will become a great anti-cancer therapy. SHATO has been a centre of oncology research and treatment in Bulgaria for more than 70 years and we are excited to explore new treatment options where limited options are currently available. This trial, which uses a dietary supplement with a benign side effect profile as an adjunct to chemotherapy, is potentially a very important step in improving the quality of life of patients with colorectal cancer.”
Dr Bjørn Kristiansen, GlycaNova’s Founder and Chief Executive Officer, said:
“We are delighted that the first patient has been dosed in this pioneering clinical trial of LentinexHP, which is being given as a dietary supplement alongside chemotherapy in late-stage colorectal cancer. The start of the trial, which follows earlier clinical and pre-clinical work, moves us forward in our quest to provide an effective adjunct therapy in solid tumour cancers to meet a very significant unmet medical need.
“I would like to thank the SHATO hospital, and the Principal Investigator Dr Stoil Boychev, for their commitment to this novel trial, the final results from which are expected around the end of next year.”
For further information, please contact:
GlycaNova +47 408 87 803
Dr Bjørn Kristiansen, Founder and CEO
Buchanan – media enquiries +44 20 7466 5000
Mark Court / Jamie Hooper
Notes to editors
GlycaNova is an innovative Norwegian biotechnology company focused on the modulation of the immune system using proprietary beta-glucans, which are undenatured and retain their triple helix, three-dimensional structure. GlycaNova has shown that its structurally intact, undenatured beta-glucans are significantly more bioactive than denatured beta-glucans.
Beta-glucans are a type of naturally occurring carbohydrate with known therapeutic potential.
GlycaNova’s intellectual property includes a proprietary manufacturing process, based on fermentation, to produce beta-glucans from medicinal mushrooms such as shiitake and reishi. This process enables the production of large quantities of beta-glucans with high biological activity and high structural integrity.
GlycaNova is developing an exciting pipeline of beta-glucans for human and animal health including an adjunct therapy in cancer treatment, LentinexHP, and novel feedstuff additives for salmon, shrimp, chicken and pig farming. The Company has launched two consumer healthcare products: the nutritional supplement Lentinex for immune system support and the emollient cream Ganodex for the symptomatic treatment of psoriasis, eczema and other skin conditions.
GlycaNova, whose intellectual property is protected by an extensive patent estate, was founded in 2009 and is based in Fredrikstad, Norway. Further information is available at: https://glycanova.com
LentinexHP is an experimental 1, 3 beta-glucan derived from the mycelium of the shiitake mushroom, Lentinula edodes, and manufactured through GlycaNova’s novel manufacturing process. LentinexHP differs from the Company’s commercially available product Lentinex by having a higher fraction of high molecular weight beta-glucan molecules.
- 1 Laiza Steimbach, Ariela Victoria Borgmann, Gabriella Giandotti Gomar, Lucas Ventura Hoffmann, Renata Rutckeviski, Diancarlos Pereira de Andrade, Fhernanda Ribeiro Smiderle. Fungal beta-glucans as adjuvants for treating cancer patients – A systematic review of clinical trials. Clinical Nutrition 40 (2021) 3104-3113. https://www.clinicalnutritionjournal.com/article/S0261-5614(20)30650-6/fulltext
- International Agency for Research on Cancer. https://www.iarc.who.int/cancer-type/colorectal-cancer/
- 3 Jean-Michel Gaullier, Jowita Sleboda, Erik Snorre Øfjord, Elling Ulvestad, Minna Nurminiemi, Cecile Moe, Tor Albrektsen, Ola Gudmundsen. Supplementation with a soluble beta-glucan exported from shiitake medicinal mushroom, Lentinus edodes (Berk.) singer mycelium: a crossover, placebo-controlled study in healthy elderly. International Journal of Medicinal Mushrooms, 13(4): 319–326 (2011).
- Global Cancer Observatory https://gco.iarc.fr/today/data/factsheets/cancers/10_8_9-Colorectum-fact-sheet.pdf