Avacta Announces FDA Approval of its Investigational New Drug (IND) Application for AVA6000

Key Facts

As previously announced in August 2021, the Company has begun recruiting and dosing patients for this study at several clinical trial sites in the UK, and continues to expect the dose escalation phase for this trial to complete by Q2 2022 followed by completion of the dose expansion phase around mid-2023.
Dr. Alastair Smith, Chief Executive of Avacta Group, commented: “We are delighted to have received approval from the FDA to add clinical trial sites in the United States as part of the Phase I study for AVA6000.
Provided that the study shows that the pre|CISION™ technology is effective in reducing systemic toxicity of Doxorubicin, then that would open up an extensive and proprietary pipeline for Avacta of next-generation pre|CISION™ chemotherapies with significant clinical and commercial advantages in a chemotherapy market that is expected to exceed $74 billion by 20272.
The clearance of the AVA6000 IND by the FDA enables the opening of key US sites to support the ALS-6000-101 clinical trial which is currently recruiting patients across clinical sites in the UK.” 1.