Development programs include:
Treatment of Myocardial Ischemia
Phage supplied FGF-1 has been studied in 2 human investigator-sponsored phase 1 trials. These studies demonstrated the ability of FGF-1 to stimulate the growth and repair of damaged myocardium and promote angiogenesis in ischemic cardiovascular tissues following intra-myocardial injection in patients with coronary heart disease.
Chronic Tympanic Membrane Perforations
FGF compounds have been demonstrated to increase the closure rate and decrease the time to total closure of chronic eardrum perforations, which may replace costly surgical procedures. Phage holds a U.S. IND with the FDA to evaluate this “first-in-class” use for FGF-1 in the treatment of tympanic membrane perforation (TMP). Phage is currently preparing to initiate a U.S. Department of Defense funded Phase 1 study for the treatment of chronic TMP
Chronic Wound Therapy
Phage holds a U.S. IND with the FDA, evaluating FGF-1 for the treatment of diabetic foot ulcers, a common chronic wound indication and the most expensive and complicated aspect of treating patients with advanced diabetes. FGF-1 may be used in the treatment of other chronic and traumatic wounds including pressure ulcers, stasis ulcers, surgical incisions, and burns.
Phage’s proprietary peptide immuno-adjuvant ligand is administered in a composition containing the antigen of interest. The novel innate immune response of these compositions is based on the observation that activation of a specific family of regulatory transmembrane G-coupled protein receptors (GCPR) increases innate and adaptive immune surveillance for the co-administered antigen(s). Additional studies in animals are starting funded by an NIH grant are getting underway at Duke University. The market competitors are compounds, which induce adaptive immune responses. There is a large unmet need for an adjuvant that can induce innate immunity.