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GV1001 Shows High Potential as Alzheimer's Treatment... Continued Coverage by Foreign Media

[Asia Economy Reporter Hyunseok Yoo] GemVax & Kael's GV1001 is gaining high recognition as a potential treatment for Alzheimer's disease not only in Korea but also overseas.


According to GemVax on the 27th, at the international dementia forum 'Dementia Forum X (DFX)' held on the 26th, Professor Philip Scheltens, a world-renowned expert in the field of Alzheimer's disease, gave a presentation on the achievements of GV1001 as a new drug candidate for dementia treatment.


Recently, reports on GV1001 as an Alzheimer's disease treatment have continued from Infoma, a global media group that owns multiple specialized pharmaceutical media outlets such as BioWorld, Scrip, and Pink Sheet, with BioWorld being known as the largest and most influential news service covering the global biopharmaceutical and medical technology industries.


On the 24th (local time), BioWorld covered the results of the Phase 2 clinical trial of GV1001 in detail and announced plans to submit an IND for the Phase 3 clinical trial targeting patients with moderate to severe Alzheimer's disease to the Korean Ministry of Food and Drug Safety within the year. Patient recruitment will begin in the first half of next year.


Following this, on the 25th (local time), Infoma reported, "Expectations for Alzheimer's disease treatments have increased due to GemVax's positive Phase 2 clinical trial results," adding, "Based on the very encouraging Phase 2 results, if the Phase 3 clinical trial is conducted, verification on key evaluation indicators assessing the potential as an Alzheimer's disease treatment will be fully possible."


At the international dementia forum 'DFX' held at COEX, Seoul on the 26th, GV1001's competitiveness as an Alzheimer's disease treatment was also highlighted. Professor Philip Scheltens, head of the Alzheimer's Center at Vrije Universiteit Amsterdam, presented research achievements on Alzheimer's disease treatments including Korea's GV1001, Biogen's Aducanumab, and Green Valley's GV971, stating, "The substance GV1001 developed by Korea's GemVax is a drug with a very high chance of success."


Professor Scheltens is an expert actively engaged in research in the field through the Neuroscience Society, International Society of Psychopathology, American Neurological Association, and European Alzheimer's Disease Consortium. He currently serves as an editorial board member and reviewer for global academic journals related to Alzheimer's disease. Additionally, he was ranked 6th worldwide last year in the field of Alzheimer's expertise. At the event, as the main speaker, he introduced GV1001 and explained the research and achievements of global pharmaceutical companies in Alzheimer's treatment.


He introduced, "GV1001 was initially developed as an anticancer agent but is now being developed as an Alzheimer's disease treatment through mechanisms such as anti-inflammatory, antioxidant, and cell-protective effects," emphasizing the results from clinical trials targeting severe patients.


Professor Scheltens stated, "In studies involving severe patients, all patients administered GV1001 showed significant improvement in SIB scores," and stressed, "This is hopeful and important because such results have never been seen in clinical trials targeting patients with similar severity."


He also added, "The fact that the CDR-SOB (Clinical Dementia Rating Scale Sum of Boxes) showed a similar trend following the improvement in SIB scores of severe patients is also very meaningful and a promising aspect for the future."


He said, "I understand that GV1001 is planning clinical trials in Europe and the United States based on these hopeful results," and added, "For the clinical trials conducted in Europe, I advised including additional indicators such as biomarkers in the trials, and I will play a role during the clinical trial process to provide necessary support for development."


A pharmaceutical industry official commented, "The reason Professor Scheltens views the success potential of GV1001 highly is that, in a situation where drug development targeting a single mechanism has repeatedly failed, GV1001 acts broadly on mechanisms beyond the conventional amyloid beta or tau protein pathways, including anti-inflammatory, antioxidant, cell-protective effects, and immune-related mechanisms." This comment highlights the significance of Professor Scheltens' evaluation.


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