PRODUCTS
- ES135:

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

Compassionate Use
  • 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:

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

  • Clinical trial material, early stage clinical trials

Phase 1

  • General Safety/Exploratory PK & PD

Phase 2

  • Efficacy- Proof of Concept, DPH contribution
  • Zolpidem Lorazepam Contributions

Phase 3b Sleep Lab Study

  • Efficacy- Phase Advance; Zol and Lor Contribution