Seoul, November 27, 2001 – Samsung Seoul Medical Center's clinical result on a Korean biotech start-up's new drug candidate developed for the prevention and treatment of Alzheimer's disease showed a remarkable improvement in cognitive functions as well as treatment of symptoms.
In particular, the result is gaining the focus of attention as the compound¡¯s protection against decline in memory and cognitive functions is hinting the possibility of development into a new Alzheimer drug. Memory and cognitive functions are critically related to the onset of Alzheimer's disease. The development of new drug will make way for a Korean biotech start-up to enter a $200 billion global Alzheimer market.
On November 27th, of Samsung Seoul Medical Center (Director, Jong-Chul Lee) announced that the result of administering INM176, a Korean herb extract, for three month to male and female test subjects ranging from 51 to 79 years of age with memory decline has shown drastically improvement in their symptoms and cognitive function.
According to the clinical research team led by SMC's neuropsychiatry specialist Dr. Doh-Kwan Kim, as a result of dividing 120 test subjects into two groups and administering 400mg of INM176 to one group everyday for 12 weeks, their ADAS-Cognition (Alzheimer's Disease Assessment Score-Cognition) scale has decreased an average of 4.48 points in comparison to the control group. The decrease in ADAS-cognition scale indicates an improvement in cognitive function and that symptoms of the disease have subsided.
In the cases of other existing Alzheimer drugs, similar clinical tests using Alzheimer¡¯s disease patients have only resulted in approximately 2-3 point decrease in the ADAS-Cognition level. Furthermore, INM176 has been shown to be more effective in the group experiencing a more serious memory decline. For this group, the ADAS-Cognition level was lowered by an average of 6.8 points.
"Despite twelve-week clinical trial, the researchers are so impressed by INM176 in its potential to treat the once believed to be untreatable disease", said Dr. D.K. Kim who led the clinical trials. "The results show that while subjects who took INM176 exhibited a significant improvement in cognitive functions, almost no side effect was observed. With the supplement of 6~12 month long-term clinical data, it would be possible to develop into a new drug", he further added.
INM176 is a natural compound discovered and developed jointly by Scigenic Co., Ltd. and Hallym University's Institute of Natural Medicines. Scigenic is currently using INM176 to develop a new drug both preventing and treating Alzheimer's disease. Hee Sul Lee, CEO of Scigenic said, "It is significant in that a compound developed in Korea has shown a supreme efficacy as a drug battling Alzheimer's disease. The results of this clinical test will no doubt provide an impetus to the research in the development of a new drug." "In the meantime, we plan to diversify our product mix so that INM176 is available in other forms such as food and nutriceutical to 60 million people who are suffering from the terrible disease", he explained commercialization plan of IMN176.
Scigenic has already commercialized and launched many functional food and dietary supplements using INM176 as an active ingredient. It is extracted from an herb commonly used in traditional Oriental medicine, and its aid in blood circulation, formation, psychiatric symptoms, as well as analgesic property have been widely recognized. SMC's recent clinical trial is credited as having used western medical methodology to prove traditional Asian medical knowledge that has been compiled for over thousands of years.
INM176's Effect Against Alzheimer's Disease Confirmed
* Chart 1: While the group that was administered with INM176 for 12 weeks has shown an improvement in memory function (as measure by ADAS-Cognition scale), control group exhibited a slight increase in the symptoms.
The result of the clinical test is significant because it not only confirmed the efficacy of INM176 against Alzheimer's disease, but also opened up the possibility of developing a drug with superior efficacy over existing drugs on the market.
This compound's supremacy becomes evident from the comparison of changes in ADAS-Cognition with existing drugs. ADAS-Cognition scale is generally used to measure the progression of Alzheimer's disease. It is composed of total 13 sections such as vocabulary recollection, dictation, composition ability, delayed recollection, naming objects, repetition behavior, and concentration/vagueness. The total score is calculated by adding the error points from each section. It ranges from 0 to 70 and higher score indicates the seriousness of accompanying symptoms.
According to SMC's clinical data, INM176-administered group's ADAS-Cognition scale before being given INM176 was an average of 21.52 (control group: 20.21). After 12 weeks of treatment with INM176, the group scored an average 17.04, resulting in a decrease of 4.48 points. On the other hand, placebo-control group saw its score increase 1.11 point from 20.21 to 21.32. While decrease in the score indicates an improvement in the overall condition, an increase indicates that progression of the disease is taking place (Chart1).
Comparing Efficacy with Existing Alzheimer's disease drugs
When comparing to other drugs, INM176's role in lowering the ADAS-Cognition scale by as much as 4.48 point poses a great significance.
In the case of a Japanese pharmaceutical company's drug that dominates 82% of the $670 million global market, the 12-week clinical trial generated an ADAS-Cognition scale difference of only 2.25 between the treated and the control group. Another multinational pharmaceutical company's Alzheimer drug resulted in an ADAS-Cognition scale difference of 3.2.
Though the SMC's clinical trial was an comparative study against other Alzheimer drugs, when examining the clinical data of different FDA-approved drugs on the market it is evident that Scigenic's INM176 outperformed in the area of improving memory and cognitive functions.
SMC's Neuropsychiatrist D.K. Kim who led the clinical trial said, "While the length of the trial was limited to 12 weeks, subjects who were administered with INM176 showed a major improvement in cognitive function without any serious side effects." "With the results of a long-term clinical trial, I feel that there is great potential in developing INM176 as a new drug," he added.
Research team also recognized that INM176's safety is quite impressive. According to the clinical data, common side effects such as nausea and vomiting which are associated with the use of existing medicines were not prevalent in INM176.
Scigenic's psychiatric specialist, Dr. Jae-Gyoung Kim said, "The existing Alzheimer drugs are acetylcholineesterase inhibitors that alleviate some of the symptoms, thereby slowing the progression of the disease. Similarly, the medical community has longed for the introduction of a new drug with a different mechanism that would fundamentally treat the illness. The result obtained from this clinical trial has opened up the possibility of INM176's development into a new drug, and it will certainly be a good news for everyone", Dr. Kim explained the significance of INM176 clinical trial.
Global Alzheimer¡¯s disease Drug Market
The current global Alzheimer¡¯s disease drug market is dominated by Ariceptâ, developed by Japan¡¯s Eisai Co. In year 2000 alone, the size of global Alzheimer market reached $670 million, of which Ariceptâ generated an overwhelming $550 million in sales. In addition to Ariceptâ, Cognexâ (Parke Davis) and Excelonâ (Novartis) are also poised to challenge the achievement made by the market leader.
The above drugs are acetylcholine esterase inhibitors that prevent enzymes from breaking up the neurotransmitter acetylcholine in the brain. While they are effective in slowing memory loss and alleviating the symptoms, thereby retarding the progression of the disease these drugs are considered to be far short of fundamentally treating the disease.
On the other hand, INM176 has a mechanism completely different from any other Alzheimer drugs. Studies to date have shown that it blocks the formation of a neurotoxin, beta-amyloid, in the brain, while protecting the brain cell with its powerful antioxidant property.
Although much research has been done on ascertaining the cause of the disease, beta-amyloid¡¯s role in the onset of Alzheimer¡¯s disease has been regarded as the pathological hallmark. Similarly, effectively blocking beta-amyloid from harming neurons is thought to be the key to conquering the disease.
SMC¡¯s INM176 Clinical Trial Method
1. Selecting Subjects of Study
- From May 2 to August 20, 2001, a total of 299 people between the ages of 51 to 79 who visited SSMC were given a memory test to be preliminarily selected as subjects of the study.
- Those who scored less than 25 in the K-MMSE (Korean Mini-Mental State Exam) or shown to be in a high risk for Alzheimer¡¯s type dementia after the 7-minute screening test were presumed to be experiencing handicap and thus were selected as the subjects of the study.
- Any subject with mental disability or illness, history of brain stroke, currently under medical treatment for dementia-related symptoms, and those who scored over 5 points in Hachinski Ischemia Scale were all excluded from the study.
- The 107 people who satisfied the above conditions were then randomly divided into placebo and INM176 group.
2. Study Design
- After the subjects were randomly divided into two groups, the INM176 group was labeled ¡°A¡± and the placebo group, ¡°B¡±.
- At the beginning of the study, comprehensive scientific and neurological exams were conducted on the test subjects including blood and urine test, biochemical test, and genetic test to check for large formation of apolipoprotein E.
- Using a double blind placebo controlled method, subjects were administered with INM176 for 12 weeks.
- Subjects made 5 visits (initial, 2nd, 4th, 8th, 12th week) during which researchers verified the intake and evaluated side effects.
- Neuropsychological evaluations were made on the first and 12th week to exam the effect of INM176.
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Scigenic Co., Ltd.
Scigenic Co., Ltd. is a biotechnology incubation company that specializes in new drug discovery and development. While the company is in the process of registering as a new drug, INM176, a compound proven effective in the prevention and treatment of Alzheimer¡¯s disease, other successful projects such as painkiller, anticancer, and arthritis treatment are also in the pipeline.
Scigenic has an affiliate company, Scigen Harvest Co., Ltd., that specializes in the development of plant genetic engineering technologies. Last October, using gene transformation technology the company, together with a team led by Prof. Ja O. Guh of Chonnam National University, successfully developed a transgenic rice plant with an average of 20%, up to a maximum of 26% yield increase. While Scigen Harvest also developed a new gene transformation method using bundled acupuncture needles last March, it was once again in the spotlight in April when the company announced that it has deciphered a gene related to plant¡¯s self-defense. Scigen Harvest is also handling other genetic engineering projects including the development of herbicide-, pest-, as well as stress-resistant crops.
Contact Information:
Doh-Kwan Kim, Ph.D. / SMC Neuropsychiatry, TEL: (02) 3410-3588
Jong-Bin Yoon / Scigenic Co., Ltd. TEL: (02) 3442-6744, 011-330-2629/Mobile
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INM176 Clinical Trial at Korea¡¯s Samsung Seoul Medical Center Lifts Hope for Prevention and Treatme 
