‘Gut Flora Transplantation Clinical Study Group of Experts
〜Aiming for easier access to treatment, we are challenging research and development.
Pharmacist, Doctor of Engineering Goro Tsukamoto: Former Director and General Manager of Drug Discovery Research Institute, Bell Boss, Former Visiting Professor, University of Pittsburgh, USA, Former Professor, Nagaoka University of Technology
The world’s first migraine drug, invented by Dr. Goro Tsukamoto, whose life’s work is the research and development of new drugs, was reported on NHK TV and in newspapers, and two other new drugs have been introduced to the world. We asked Dr. Tsukamoto, who has been serving as an auditor since the establishment of this research group, about the possibility of transplanting intestinal bacteria (plexus), which he admits is “comparable to a groundbreaking new drug.
–Please tell us about your hopes for the possibility of transplanting intestinal bacteria (plexus).
In recent years, transplantation of intestinal bacteria (plexus) has been researched and developed in many countries, but no reliable method is known. However, several years ago, Dr. Makoto Shimizu, a clinical laboratory technician in our laboratory, invented and developed a new method of transplantation of intestinal bacteria (plexus). The novelty of this method can be seen from the fact that it has been patented in Japan and an international patent is pending. At today’s convention, clinical research results on children with autism spectrum disorder using this method will be presented, and you can look forward to extremely interesting results. However, it is still some time before this new drug is available for general use.
–You say that “it takes time,” but how much time is needed exactly? And why does it take so long?
It is well known that research and development of new drugs takes time, and it is difficult to comprehend, but let me briefly explain. The time it takes for a new drug candidate to be discovered and invented is not so simple that it can be clearly stated, but if I had to guess, it would be 5-15 years. If a candidate is lucky enough to be discovered and successfully passes through non-clinical trials (various tests using non-human subjects), it will then proceed to clinical trials (clinical trials) to determine whether it is effective and safe for humans, which generally takes 3 to 7 years. The results of these trials are used to make a decision as to whether or not the drug is safe and effective for humans. If the results are acceptable, the drug is submitted to the Ministry of Health, Labour and Welfare for review, and after passing the review, the Pharmaceutical Affairs and Food Sanitation Board, composed of academic experts and others, deliberates on the drug, and once the Minister of Health, Labour and Welfare grants approval, the drug can be manufactured and sold as a pharmaceutical product. This process takes one to two years. Therefore, assuming that our current specific clinical research is completed as projected, the total time required for the next “clinical trial and review” would be 4 to 9 years, but this is a typical number of years, and we hope to release the product to the market in 4 years or less at the earliest.
— So, finally, please tell us about the future prospects of the Intestinal Flora Transplantation Clinical Study Group.
The “method of using the proprietary nanobubble technology for the transplantation of intestinal bacteria (plexus),” which was developed based on the knowledge, experience, and technology unique to Shimizu clinical laboratory technicians, has many applications in order to deliver intestinal bacteria (plexus) in a more natural way to patients, rather than the conventional transplantation using saline solution. The method is based on the knowledge, experience, and technology of clinical examination techniques unique to clinical technicians. Once the current approval for use in the treatment of autism spectrum disorder is obtained, new themes will start one after another.
Thanks to the team effort of many doctors led by Dr. Zen Tanaka, a professional medical doctor, the advisory board of Hamaguchi, Shima, Otani, and Ishihara, led by Dr. Saiko Iwasaki, a professional in pharmaceutical research and development, and other top specialists such as Dr. Taiichi Katayama of Osaka University and Dr. Kenji Tsuchiya of Hamamatsu University School of Medicine, we are now in the present. The future of this research group is bright and will continue to grow.
As a chemist whose life’s work has been in drug discovery, I am grateful to have encountered a revolutionary biologic drug and its technology, the Intestinal Bacteria Delivery System (abbreviated as iBDS), which is not a so-called biologic drug (a protein produced by an organism is the main drug), but is truly a drug that uses the intestinal bacteria (plexus) itself as the drug.
The 7th Annual Conference [Report] is here.