SEATTLE, Wash., May 15, 2015 /PRNewswire/ -- TapImmune, Inc. (OTCQB: TPIV), is pleased to announce that an Abstract on a Phase I Study on the Safety and Immunogenicity of a folate receptor alpha (FRAα) peptide vaccine has been published in J Clin. Oncol., 33:5s, 2015 (suppl; abstr e14028) which, is a compilation of abstracts submitted to the 2015 ASCO Annual Meeting (http://am.asco.org/).
FRα is overexpressed by multiple cancers, including triple negative breast, ovarian and non-small cell lung cancers. Endogenous T-cell immunity to each of five FRα peptides had been demonstrated in patients with breast and ovarian cancer indicating the feasibility of targeting FRα via a vaccine approach. Phase 1 studies were conducted at the Mayo Clinic, Rochester, MN . Twenty-two patients with breast or ovarian cancer who had undergone standard surgery and adjuvant treatment were vaccinated with a mixture of the 5 FRα peptides for a maximum of 6 vaccination cycles. Vaccine treatments were generally well tolerated with mild to moderate toxicities.
Importantly, FRα-specific T cell responses were observed in 20 of 21 patients with immune response data. Of these, 16 of 16 patients with observation data had demonstrable CD4 and CD8+ T cell responses which, persisted after the completion of vaccine therapy.
"These immune response data provide a strong rationale for progression into Phase II trials. We have assembled an experienced team of advisors and experts to assist us in moving the next trial forward as quickly as possible," commented Dr. Glynn Wilson, Chairman and CEO of TapImmune. "For example, GMP manufacturing of peptides for Phase II trials is already underway and final analysis of clinical plans and clinical sites for the treatment of triple negative breast cancer is nearing completion for the start of Phase II studies later in 2015," Dr. Wilson added.
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