Date: 2017-07-18
Type of
information: Clinical trial authorisation
phase: 3
Announcement: clinical trial authorization
Company: Abeona Therapeutics (USA - NY)
Product: EB-101 (gene corrected skin grafts)
Action
mechanism:
- gene therapy. EB-101 is an autologous, ex-vivo gene therapy in which the COL7A1 gene is transduced into autologous keratinocytes for the treatment of recessive dystrophic epidermolysis bullosa.
- The EB-101 program has been granted Orphan Drug and Rare Pediatric Disease Designations from the FDA and Orphan Drug Designation from the EMA.
Disease: dystrophic epidermolysis bullosa,
Therapeutic
area: Rare diseases - Genetic diseases - Dermatological diseases
Country: USA
Trial
details:
Latest
news:
- • On July 18, 2017, Abeona Therapeutics announced guidance from a recent Type-C meeting with the FDA which has recommended accelerating the EB-101 program into a pivotal Phase 3 trial. The company continues to engage the FDA on the final Phase 3 clinical trial design, planned to commence early 2018, and will provide an update on the program in the coming months.
Is
general: Yes
