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. VGN-R09b, a recombinant adeno-associated virus (rAAV) based gene therapy self-developed by Vitalgen, is currently investigated in a Phase I/II clinical trial for subjects with idiopathic Parkinson's disease (iPD), as well as another Phase I/III trial indicated for aromatic L-amino acid decarboxylase deficiency (AADCD).
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 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.
EA Policies for Single Patient