Professor Lee Ji-young of Seoul National University College of Medicine Holds Press Conference on Clinical Results and Significance
Supported by Global Experts and Patient Groups... Accelerating Global Phase 3 Clinical Trials
GemVax & Kael will release the full presentation video to properly inform the results of the Phase 2a clinical trial of GV1001, a progressive supranuclear palsy (PSP) treatment that has attracted global attention.
On the 28th, GemVax announced that it will soon release the entire presentation video from the international conference Neuro2024 held on the 24th, and will organize a session to explain the significance and value of the clinical trial together with world-renowned scholars and experts in related fields both domestically and internationally.
PSP is a rare disease with no treatment available worldwide. Although many studies have been conducted to overcome the disease, most cases have yet to find even a tendency to delay disease progression.
Regarding GV1001, global scholars have evaluated it as showing potential not just as a symptomatic relief agent but as a fundamental treatment (disease modifying drug).
On the 24th, at the Neuro2024 conference held in Toronto, Canada, GemVax announced that the GV1001 0.56mg administration group showed excellent effects, and especially confirmed high potential as a treatment in patients with the progressive supranuclear palsy Richardson syndrome (PSP-RS) type. This announcement received recognition and high praise from global scholars and experts.
To publicize the results of this clinical trial, GemVax, in consultation with CurePSP, the organizer of the Neuro2024 conference, will release the full presentation video containing the clinical data of GV1001. Dr. Peter Sch?ler, Senior Vice President of New Drug Development at ICON, a global clinical trial contract research organization and a neurologist, will provide a detailed explanation of the clinical results and why the results of this trial make it possible to obtain approval to enter Phase 3 clinical trials globally, including in the United States and Europe.
Professor Ji-Young Lee, head of the clinical trial and a neurologist at Seoul National University College of Medicine (Seoul National University Boramae Medical Center), will hold a press conference to explain in detail the value of PSP disease and clinical research.
Executives from CurePSP will soon visit Korea in person to express gratitude for the progress of this PSP clinical trial and to seek concrete cooperation plans for conducting global Phase 3 clinical trials for rapid drug development. Founded in 1990 and based in New York, USA, CurePSP is a nonprofit charitable organization that supports innovative research on the causes and treatments of PSP, corticobasal degeneration (CBD), and other diseases, providing various support through a broad global network of experts, patients, and patient families.
In the case of rare disease drug development, if a meaningful trend is confirmed in the Phase 2a clinical trial, it is possible to proceed directly to Phase 3 clinical trials. Experts worldwide in related fields also expressed the opinion that the U.S. Food and Drug Administration (FDA) will actively review clinical trials for diseases without treatments, such as PSP.
Having secured important evidence and successful clinical design data for commercialization through the clinical trial, GemVax plans to accelerate the promotion of global Phase 3 clinical trials. Already, 49 specialized institutions in five countries including the United States and the United Kingdom have shown interest, and among them, 22 have completed selection and are about to sign the main contracts.
A GemVax official said, "It is regrettable that despite achieving results that could change the global new drug development landscape by developing a rare disease treatment for PSP from a small Korean new drug development company, its value is not being properly recognized domestically." He added, "Through this opportunity, we hope to properly publicize our clinical achievements and further raise social interest and consensus on PSP and rare diseases."
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