Shanghai Vitalgen BioPharma Co., Ltd. (Vitalgen) is a biopharmaceutical company dedicated to translating cutting-edge gene delivery and gene editing techniques into clinically effective treatments for patients with unmet medical needs.
Among the investigational therapies in Vitalgen's pipeline are two key gene therapy products:
VGN-R09b is a recombinant adeno-associated virus (rAAV) based gene therapy currently being evaluated in a Phase I/II clinical trial for idiopathic Parkinson's disease (iPD), as well as in Phase I/III trial for aromatic L-amino acid decarboxylase deficiency (AADCD).
VGN-R08b is an rAAV based gene therapy product targeting GBA-Associated Parkinson's Disease (PD-GBA) and neuronopathic Gaucher disease (nGD), advancing toward registrational clinical studies. A previous investigator-initiated trial (IIT) in China for Gaucher disease type II (GD2) has completed enrollment, with the study now in the long-term follow-up stage.
Expanded Access is a potential pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational therapy for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. Vitalgen recognizes patient interest in accessing VGN-R09b and VGN-R08b outside of clinical trials, however, we are not currently offering any Expanded Access programs. For information on relevant clinical trials, please refer to our main webpage: http://www.vitalgen.com/en/index.php?c=category&id=3.
Vitalgen acknowledges the importance of Expanded Access and may revise this policy at any time.