Following tissue injury or vascular damage thrombin is activated to form blood clots. A portion of thrombin that includes the TP508 peptide sequence is subsequently released to reduce inflammation, restore endothelial cell function and recruit stem/progenitor cells to initiate tissue repair.
TP508 binds receptors expressed on the surface of endothelial cells, stem cells, and certain inflammatory cells. Upon binding to these receptors, TP508 activates a signaling cascade that restores vascular function in endothelial cells, stimulates proliferation and mobilization of progenitor stem cells, and reduces inflammation.
Clinical Trials. TP508 has demonstrated safety and potential efficacy in human clinical trials for treatment of diabetic foot ulcers (Phase 2) and to accelerate healing of wrist fractures (Phase 2 and 3).
Preclinical Efficacy. A single injection of TP508 has demonstrated significant benefit in mitigating effects of nuclear radiation exposure, brain cancer radiation therapy, and traumatic brain injury. More recently, TP508 injection has been shown to prevent lung inflammation and the “cytokine storm” caused by SARS-CoV-2 infection in transgenic mice. Thus, TP508 has potential to save lives and improve life’s quality for millions of people.
Drug Status. As an investigational drug product, TP508 is ready for additional clinical trials
- Production: synthetic peptide drug substance is cGMP manufactured by AmbioPharm, Inc.
- Formulation: lyophilized white powder contained in single-use vials to be dissolved in saline and filter sterilized prior to clinical trial injection
- Stability: Raw drug product = 6+ years at -20oC
- Non-Human Safety: GLP single and multiple IV and SC injection toxicology, repro-tox, oncogenicity and QT prolongation studies, rodent and non-rodent PK/ADME
- Human Clinical Safety: No drug related adverse effects with local administration to ~600 human subjects.