Positive Interim Safety Analysis Achieved in Breast Cancer Patients Treated with HER2/neu Antigens
SEATTLE, Jan. 9, 2013 /PRNewswire/ -- 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.
About TapImmune Inc.
TapImmune Inc. is a vaccine technologies company specializing in the development of innovative gene based immunotherapeutics and vaccines in the areas of oncology and infectious disease. The Company's lead product candidates, include vaccines designed to restore and augment antigen presentation and subsequent recognition and killing of cancer cells by the immune system. The Company is also developing TAP-based prophylactic vaccines commercially suitable for the prevention of infectious diseases and as Biodefense agents. As a vaccine component, the gene based TAP technology has the potential to significantly improve the efficacy of both prophylactic and immunotherapeutic vaccines as it addresses a fundamental mechanism for T cell recognition and response. Unlike other vaccine technologies that address only the initiation of immune responses, TAP expression also has the unique ability to enhance the effector function of mature killer T cells. This enhancement of effector function is potentially complementary to any/all vaccine approaches that are designed to enhance cellular responses. The Company is developing cancer vaccines that combine the use of novel antigens together with its TAP expression technology.
Glynn Wilson, Ph.D.
Chairman & CEO
Forward-Looking Statement Disclaimer
This release contains forward-looking information within the meaning of the Private Securities Litigation Reform Act of 1995. Statements in this news release concerning the Company's expectations, plans, business outlook or future performance, and any other statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are "forward-looking statements". Forward-looking statements are by their nature subject to risks, uncertainties and other factors which could cause actual results to differ materially from those stored in such statements. Such risks, uncertainties and factors include, but are not limited to the risks set forth in the Company's most recent Form 10-K and other SEC filings which are available through EDGAR at www.sec.gov. The Company assumes no obligation to update the forward-looking statements.
SOURCE TapImmune Inc.
Posted: January 2013