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SEATTLE, WA & Rochester, Minn. TapImmune Inc. (OTCBB: TPIV),a leading biotechnology company developing immunotherapies, today announced that following FDA IND approval, it will sponsor a Phase I HER-2/neu targeted therapeutic vaccine trial in HER-2/neu positive breast cancer patients at the Mayo Clinic.
The trial stems from a technology license option and sponsored research agreements between Mayo Clinic and TapImmune and is based on research on novel immunogenic peptide epitopes of the HER-2/neu antigen discovered in breast cancer patients with pre-existing immunity to HER-2/neu. The trial is jointly led by Keith Knutson, Ph.D and Amy Degnim, M.D. Mayo Clinic. According to Dr Knutson, “HER-2/neu is associated with aggressiveness in breast cancer and in our preclinical mouse studies we found that boosting HER-2/neu-specific immunity blocks tumor growth. In the planned human clinical trial, the goal will be to determine whether we can also boost immunity to HER-2/neu in patients, hopefully paving the way to asking whether vaccination blocks tumors in humans”.
In the upcoming trial, HER-2/neu positive breast cancer patients will be given the vaccine mixed with GM-CSF as an adjuvant to enhance immunity. The trial aims to evaluate the safety of this vaccine as well as immune responses.
According to TapImmune’s Chairman and CEO, Dr Glynn Wilson, this major milestone event for the company represents the first step in the development of a novel HER-2/neu vaccine that augments both CD4 T-helper cells and CD8 cytotoxic T-cells. This technology may ultimately work synergistically with TapImmune’s core TAP technology with the aim of producing a robust and long-acting immune response in a broad population of HER-2/neu positive breast cancer patients. “Immunotherapies are increasingly playing a major role in oncology to prolong patient survival and quality of life. TapImmune is delighted to be collaborating with leaders at the Mayo Clinic to translate pioneering research into new treatments.”
The trial is due to commence recruitment in the 4th quarter of 2011. Under the terms of the technology license option agreement with the Mayo Clinic, TapImmune has an exclusive worldwide option to become the exclusive licensee for sale of any resulting commercial vaccines.
About TapImmune
TapImmune’s unique approach is designed to increase the efficacy of vaccines by enhancing antigen presentation through the use of the Transporter of Antigen Processing (‘TAP’). Replacement of this transporter provides a significant immune response with the potential to treat a variety of cancers which lack normal amounts of TAP. TapImmune's lead product candidate, AdhTAP, is designed to restore and augment antigen presentation and subsequent recognition and killing of cancer cells by the immune system. The Company is currently planning the development of AdhTAP for the commencement of clinical manufacturing and toxicology studies. As a stand-alone cancer therapy or in combination with other drugs, AdhTAP could prove to be a key component of a more successful assault on cancer. TapImmune is initiating clinical development of a multi-component vaccine for the treatment of HER-2/neu positive breast cancer.
The Company is also developing a TAP-based prophylactic vaccine which initial tests indicate may increase the efficacy of targeted prophylactic vaccines by up to 1000 times. TapImmune's TAP technology could significantly improve the efficacy of many current prophylactic vaccines and enhance the creation of new ones in the fight against many pandemic infectious diseases. A next generation smallpox vaccine is currently in preclinical development.
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.
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