GemVax "Received Proposal from FDA to Expand Clinical Trial Indications"

[Asia Economy Reporter Hyunseok Yoo] GemVax & Kael (hereinafter GemVax) announced on the 14th that it plans to expand the global clinical trial indications of GV1001 for Alzheimer's disease and to simultaneously commence clinical trials in the United States and Europe within this year.

On July 18, GemVax received the Phase 2 clinical study report (Clinical Study Report, hereinafter CSR) for Alzheimer's disease from Parexel, one of the world's top three CROs.

The primary endpoint, Severe Impairment Battery (SIB), showed a remarkable improvement effect (7.11). Additionally, among the secondary endpoints, the Neuropsychiatric Inventory (NPI) and the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL), which are highly significant for evaluating daily living activities of Alzheimer's patients, also demonstrated outstanding statistical significance.

Regarding this, overseas advisory members stated, “The improvement in SIB scores in patients with moderate or higher Alzheimer's disease and the significant results in secondary endpoints such as NPI and ADCS-ADL are very fascinating. Considering these results, it is possible to expand the indications to mild Alzheimer's disease and mild cognitive impairment in the future, developing it as a treatment across all stages of dementia.”

GemVax also received a proposal to expand indications from the U.S. Food and Drug Administration (FDA). Final negotiations for conducting clinical trials locally in the U.S. are scheduled for next week.

GemVax plans to begin recruiting clinical trial patients in the U.S., where approval has already been granted, starting early next year, and to apply for approval (IND) for clinical trials with expanded indications in the U.S. and Europe within this year to the FDA and the European Medicines Agency (EMA).

GemVax stated regarding technology transfer, “Although we have received L/O proposals from several domestic pharmaceutical companies, considering the clinical trial progress and marketing issues targeting a market expected to grow to $12.894 billion by 2028, we have decided to pursue license agreements with global pharmaceutical companies.”

Furthermore, Yogen Winlos, the newly appointed head of investment at GemVax, emphasized, “The results of GemVax's Alzheimer's disease clinical trials are very encouraging. In fact, since last month, we have started discussions on L/O with global pharmaceutical companies based on this data, and rapid progress is being made with several companies with whom concrete negotiations have already begun.”

Kim Sangjae, Chairman of GemVax, said, “I believe that R&D companies demonstrate their achievements through clinical trial results. We will show results not only for pancreatic cancer but also for Alzheimer's disease and benign prostatic hyperplasia.”

This content was produced with the assistance of AI translation services.