Contact Us

Expanded Access

EXPANDED ACCESS
What is the Expanded Access Program?

Expanded Access Programs (in the US), also known as compassionate use
(in the EU), allow the use of investigational products that have not yet received
marketing authorization as a potential treatment option for patients suffering
from severe or life-threatening conditions for whom satisfactory effects from
existing treatments are not expected.

It aims to offer a last treatment opportunity to patients for whom existing
therapies are ineffective, allowing for the limited use of investigational
products under the responsibility of the attending physician.

  • For more information from the FDA about expanded access in the U.S. Click Here
  • For more information from the EMA about expanded access in the EU Click Here
  • For more information from the MFDS about expanded access in Korea Click Here
Who is being considered for the Expanded Access Program?
  • 1

    A patient suffering from a life-threatening condition with no available treatment.

  • 2

    A patient unable to participate in ongoing clinical trials for the condition.

  • 3

    A patient who has a disease for which there is sufficient evidence of a prospect (or concept) benefit from the use of the investigational product.

  • 4

    A patient whose country of residence/affiliation allows the provision of the investigational product through EAP/Compassionate Use

GemVax Expanded Access Programs

GemVax may permit the provision of investigational products to individuals with high unmet medical needs who are unable to participate in clinical trials and have no remaining treatment options.

The local regulatory authority may allow patients access to GV1001, GemVax’s
Investigational Product, through the EAP/Compassionate Use program before
its marketing approval. However, since GV1001 has not yet received regulatory
approval, its full risks and benefits to disease are unknown. Therefore, physicians
and patients should carefully weigh all potential benefits and risks when seeking
access to GemVax’s Investigational Product GV1001.

Many clinical trials for GV1001 have been conducted for various diseases;
however, currently, GemVax can only provide an Expanded Access Program (EAP)
for neurodegenerative diseases.

For Alzheimer’s Disease(AD), the global phase 2 study has been
ongoing since 2022, and the enrollment was completed in April 2024.
So, the drug, GV1001 for AD indication is not available currently on an expanded access basis.

  • If you need more information of GV1001’s EAP, please contact info@gemvax.com
  • If you want to check whether you are eligible to participate in clinical trials of GemVax, you can find information on ClinicalTrials.gov Click Here