Grant Award Details
- Objective is to complete a Phase 3 Double-Blind, Randomized, Placebo Controlled Registration Study to Evaluate the Efficacy and Safety of an endothelial cell therapy, AB-205, in Adults with Lymphoma Undergoing High-Dose Therapy and Autologous Hematopoietic Cell Transplantation.
Grant Application Details
- AB-205-301 Phase 3 Trial and Related Activities to Support Clinical Development of AB-205
Therapeutic Candidate or Device
AB-205 is an intravenously infused medicine containing genetically modified human vascular (endothelial) cells intended to repair damaged tissue
Treatment to reduce/prevent severe multi-organ complications from curative high-intensity cancer treatments involving stem cell transplantation
AB-205 acts through paracrine effects from expression of a rich mixture of reparative proteins called angiocrine factors, which in turn revive the organ's disabled stem cell vascular niches. Properly working stem cell niches are required to repair damaged tissue and restore proper organ function. AB-205 angiocrine factors act on and revive the patient's stem cell niches, which enable timely tissue repair, restore organ function, and prevent the development of severe multi-organ complications.
Unmet Medical Need
Aggressive cancers can be cured with high-dose chemotherapy, radiation and stem cell transplantation. However, highly effective cancer treatments also tend to damage healthy tissues, making patients gravely ill and prolong hospitalization. AB-205 is intended to address this serious unmet need.
Late-stage (Phase 3) trial completed
Major Proposed Activities
- Conduct and complete late-stage (Phase 3) trial of AB-205
- Conduct manufacturing and quality control activities related to the Phase 3 trial
- Conduct laboratory testing (non-clinical) activities related to the Phase 3 trial
In California alone, 9,250 new cases of lymphoma with over 2,100 deaths are estimated for 2022. Aggressive lymphoma can be cured with high-intensity treatments; however, > 50% of patients get gravely ill with serious complications that can be life-threatening. Patients who are older or have multiple health issues are often excluded because of the risks. A successful AB-205 trial could lead to Californians having a chance to be cured from lymphoma without facing serious complication risks.