IND-enabling program for PRPE-SF, the secretome from polarized stem cell-derived RPE cells, for the treatment of dry-age related macular degeneration
Grant Award Details
Grant Type:
Grant Number:
CLIN1-14789
Investigator(s):
Disease Focus:
Human Stem Cell Use:
Award Value:
$5,993,562
Status:
Active
Grant Application Details
Application Title:
IND-enabling program for PRPE-SF, the secretome from polarized stem cell-derived RPE cells, for the treatment of dry-age related macular degeneration
Public Abstract:
Therapeutic Candidate or Device
Polarized Retinal Pigment Epithelium-Secreted Factors (PRPE-SF)
Indication
Advanced Dry Age-Related Macular Degeneration (Geographic Atrophy)
Therapeutic Mechanism
PRPE-SF is comprised of multiple secreted factors produced from stem cell-derived RPE cells which provide neuroprotection, anti-inflammatory and antioxidative activity.
Unmet Medical Need
Provides a treatment option for millions of patients with geographic atrophy to preserve vision.
Project Objective
FDA IND filing for the therapeutic candidate
Major Proposed Activities
Polarized Retinal Pigment Epithelium-Secreted Factors (PRPE-SF)
Indication
Advanced Dry Age-Related Macular Degeneration (Geographic Atrophy)
Therapeutic Mechanism
PRPE-SF is comprised of multiple secreted factors produced from stem cell-derived RPE cells which provide neuroprotection, anti-inflammatory and antioxidative activity.
Unmet Medical Need
Provides a treatment option for millions of patients with geographic atrophy to preserve vision.
Project Objective
FDA IND filing for the therapeutic candidate
Major Proposed Activities
- Pre-clinical testing of therapeutic candidate (PRPE-SF)
- Manufacturing the therapeutic candidate (PRPE-SF) for clinical trials
- Develop clinical trial protocol for the therapeutic candidate (PRPE-SF)
Statement of Benefit to California:
AMD is one of the most common causes of blindness in those 50 or older with an estimated 400,000 Californians projected to suffer from AMD. With a $3 billion economic burden annually in California, AMD is a debilitating disease that results in loss of independence and productivity, increased injury and dramatic decline in quality of life. PRPE-SF is being developed in California and creating additional jobs in California.
