Precision Biologics proprietary discovery platform is our library of experimental vaccines. The unique nature of this library is defined through the human clinical data from Phase I, II and III clinical trials conducted in the late 1970s and early 1980s. The results of these trials were published in peer-reviewed medical journals published in the United States and Canada, and included the following data:
- In a Phase I trial of colorectal TAAs as vaccines, 82% of the 22 treated patients, with Dukes stages B2, C and D colorectal cancer, were alive at a median follow-up of 21 months;
- Of these surviving patients, 59% were disease-free;
- No systemic toxicity (hepatic, renal, GI, respiratory, or neurologic) was observed with the vaccine.1
A randomized Phase III study was performed with 85 patients resectable stage I and II squamous cell lung cancer, randomized into 3 groups.2 The five-year survival data were reported as follows:
[No FDA approval has been sought for the TAAs or vaccines used in the trials]
2 Source: Adjuvant, Specific, Active Immunotherapy for Resectable Squamous Cell Lung Carcinoma: a five-year survival analysis. Takita H, Hollinshead AC, Adler RH, et al. J Surg Oncol. 46(1):9-14, 1991.