TapImmune Inc. (OTCBB: TPIV) has announced that an interim safety analysis on the first five breast cancer patients treated with HER2/neu Class II antigens at Mayo Clinic, Rochester, MN., did not show any serious adverse events. As a result treatment of the remaining 17 patients in the Phase I study, being conducted at Mayo Clinic, Rochester, MN will progress. The proprietary HER2/neu Class II antigens, discovered by Keith Knutson Ph.D. and colleagues at Mayo Clinic, show high affinity binding to human MHC proteins for ~84% of the population making it potentially applicable to a broad spectrum of HER2/neu patients compared to other approaches. The Phase I trial is being carried out in breast cancer patients who finished standard Herceptin®-based therapy and are at risk of disease recurrence. The primary endpoints of the study are safety and immunogenicity. Details of the Phase I trial can be found at http://clinicaltrials.gov. TapImmune is sponsoring the Phase I study and has an Exclusive Option to License the antigen technology at the end of Phase I.
TapImmune's CEO Glynn Wilson added, "This is an important milestone for this program. As we move through clinical development it is essential that we clear these early safety hurdles and move towards development of our complete HER2/neu vaccine." Mayo Clinic and Dr. K. Knutson have a financial interest in TapImmune, sponsor of the clinical trial.