GemVax dementia drug candidate is reviewed for PSP

Central Pharmaceutical Affairs Review Committee of the MFDS reviewed the feasibility of the plan by submitting additional data

Sponsor-Investigator Trials, Alzheimer's results report required

It is considering clinical trials to verify the new drug candidate GV1001, which GemVax is developing as a treatment for Alzheimer's disease, for the rare disease progressive supranuclear pals.

 

However, the Central Pharmaceutical Affairs Review Committee, an expert advisory body from the MFDS, has postponed the judgment that additional data are needed.

 

The minutes of the Central Pharmaceutical Affairs Review Committee released by the MFDS on the 20th are as follows.

 

The meeting held on the 11th of last month was to consult with GV1001 on the feasibility of conducting a clinical trial for patients with progressive supranuclear pals.

 

GV1001 is a treatment for Alzheimer's disease that GemVax is developing.

 

In Korea, phase II clinical trial have been conducted for moderate patients and are currently pursuing phase III trial.

 

In addition, it has been approved for phase II clinical trial in the US, and is aiming to begin in the first half of this year.

 

GV1001 is the same active ingredient as Riavax, which is licensed as a treatment for pancreatic cancer.

 

It is being developed as a treatment for dementia by changing its use.

 

However, Riavax was canceled in August of last year because it did not meet CMA criteria.

 

According to the minutes of the meeting, the MFDS currently has no cure for progressive supranuclear pals.

 

Given that the applied clinical trial is an Investigator-Sponsored Trial, not a Sponsor-Initiated Trial, it was judged that it was necessary to consider approving a clinical trial protocol if it could help progressive supranuclear pals.

 

Advisors to the Central Pharmaceutical Affairs Review Committee pointed out that there are no animal studies and data on the results of phase II clinical trial for Alzheimer's disease are insufficient.

 

It could be considered by submitting additional data.

 

One member said, "Progressive supranuclear pals themselves are rare, and the speed of progression is so fast that it will be difficult to predict with an animal model.

 

The validity of the dose is a safety issue.

 

If there is data, we can consider approving the clinical trial protocol.” The chairman said, "It is necessary to submit data that can link Alzheimer's disease and progressive supranuclear pals to determine whether to replace the advanced progressive supranuclear pals animal model effect data with the Alzheimer's disease animal model effect data." "Let's review the results of the phase II clinical trial for sick patients." The committee members put emphasis on the fact that the results of phase II clinical trial for Alzheimer's disease are summary data, so it is necessary to review the full report.

 

The MFDS concluded, "We will submit additional data according to the results of the meeting," and concluded that "We will determine whether to replace the effective data after receiving the data to prove the correlation between progressive supranuclear pals and Alzheimer's disease." It added, "We will ask for additional advice if necessary after we have received a report on the results of a phase II clinical trial for patients with Alzheimer's disease and reviewed it by the MFDS." Progressive supranuclear pals are rare diseases that cause degeneration of nerve fibers in the cerebral cortex and subcortical tissues, and cause Parkinson's symptoms such as gait disorders and impaired intelligence.

 

Onset in their 50s to 60s and worsening symptoms lead to death.

 

There is no special treatment and an urgent need for a cure.