ES135 is a recombinant human acidic fibroblast growth factor (rhFGF1) with 135 amino acids. With its effect to promote neurite outgrowth, ES135 can be applied to the medical use of repairing neuron function. The sequence of ES135 has been patented in Taiwan, EU, China and the United States. A multi-center, double blind, randomized, placebo control study as the pivotal Phase 3 clinical trial for spinal cord injury is on-going.
On-going studies for Spinal Cord Injury
- Phase 3 pivotal clinical trial - is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of ES135 in subjects with complete spinal cord injury
Study sites: Far East Memorial Hospital, with Veteran General Hospital, Taipei and VGH, Kaoshung
- Protocol for Compassionate use of ES135 in subjects with spinal cord injury
Study sites: Far East Memorial Hospital
Completed Studies
No |
Phase of Study |
Number of Subject |
Location of Injury |
|
1 |
Phase 1 |
1 |
ASIA-C, thoracic |
|
2 |
9 |
Cervical |
||
3 |
45 |
CPN lesions with axonal loss |
||
4 |
18 |
Injured preganglionic brachial plexus |
||
5 |
Phase 2 |
60 |
Cervical and thoracolumbar |
|
28 |
Injured brachial plexus and CPN |
|||
6 |
Compassionate Use |
100 |
Cervical and thoracolumbar |
|
SM-1 is a 3-in-1 capsule containing 3 commercial drugs with sedative effect. The formulation of SM-1 is designed to make each of the drugs available in a staged sequence with timing of release. Patent applications covering SM-1 were filed worldwide. A Phase 3 clinical trial for SM-1 has been completed in the US.
Completed Studies
Activity |
Requirement Satisfied |
Formulation Development, Initial Manufacturing |
|
Phase 1 |
|
Phase 2 |
|
Phase 3b Sleep Lab Study |
|
