Through the Phase I and Phase IIa trials, 64 patients have received VT-111.  No serious drug-related adverse events have been reported and VT-111 has been well tolerated at all dose levels. In the Phase I trial of 16 patients, VT-111 elicited no adverse clinical effect on hematology, coagulation or clinical chemistry parameters, and was not immunogenic.  The Phase IIa study showed no difference between the treatment and placebo groups for the key safety measures, including coagulation markers and adverse events. The in-stent plaque area and lumen area, as assessed by intravascular ultrasound at six months, were similar for both groups. VT-111 demonstrated no drug-related adverse events and no neutralizing antibodies (low immunogenicity) in the patient population.

All proteins have the potential to induce an immune response. Based on a comprehensive set of data from both preclinical and clinical studies, VT-111 has demonstrated a very favorable immunogenicity profile.  Protein therapeutics with low immunogenicity have the potential for chronic therapeutic markets in addition to acute markets.