G-actin sequestering peptide. Promotes cell migration, angiogenesis, wound healing, anti-inflammatory activity. Cardiac: initiates simultaneous myocardial and vascular regeneration (Nature 2007). Ocular: reduces corneal inflammation and promotes epithelial healing.
Dry eye (strongest signal). Wound healing (Phase II mixed results). Cardiac regeneration (preclinical landmark only).
No established contraindications from clinical trials. Theoretical concern for tumor promotion given angiogenic properties.
6 Phase II trials completed across wound healing, dry eye, and pressure ulcers. Strongest signal in dry eye. 23 ICH-compliant safety studies. Nature 2007 cardiac regeneration landmark (preclinical).
- 1.RegeneRx Phase II Pressure Ulcer 2009 — safety passed. No statistically significant healing differences on primary endpoint. Mid-dose trended faster
- 2.Guarnera et al., Ann NYAS 2010 — TB4 accelerated healing ~1 month in venous stasis ulcers who healed. n=72, Phase II RCT
- 3.Sosne et al., IOVS 2015 — 35.1% reduction in ocular discomfort, 59.1% reduction in corneal staining. Improved tear film. Phase II RCT
- 4.Smart et al., Nature 2007 — first molecule to initiate simultaneous myocardial and vascular regeneration via systemic administration in vivo. Preclinical landmark
No dermal wound healing Phase II achieved statistical significance on primary endpoints. Clinical development stalled after RegeneRx financial difficulties.
Dry eye data is the strongest clinical signal. Six completed Phase II trials provide regulatory pathway foundation.