Reference Documents

The four documents referenced below detail some of the foundational pre-clinical and clinical studies behind the ECI protocol. Our sister company, TVAX Biomedical, conducted the studies described in human clinical trials in patients with highly resistant astrocytomas and renal cell carcinomas for which other therapies had already failed (e.g. radiation, chemotherapy, surgery).  In some of these challenging patients, improved survival and durable efficacy were noted despite the advanced state of the patients’ cancer. Studies in humans are continuing, however this protocol, combining both vaccines and a T cell infusion, is now available for newly diagnosed canine veterinary patients.  Based on our canine clinical trials, we see using ECI in newly diagnosed patients as giving the therapy its best opportunity for success. However, it is interesting to note in the papers below that even some of the most treatment resistant malignancies responded to this immunotherapy protocol.  These papers also make interesting reading in providing additional background information into the science, biology  and development of this immunotherapy.

    1. Autologous tumor cell vaccination combined with adoptive cellular immunotherapy in patients with grade III/IV astrocytoma.Holladay FP, et al., J Neurooncol. 27:179-89 (1996)
    2. A pilot study of autologous cancer cell vaccination and cellular immunotherapy using anti-CD3 stimulated lymphocytes in patients with recurrent grade III/IV astrocytoma. Wood GW, Holladay FP, et al., J Neurooncol. 48:113-20 (2000)
    3.  Adoptive immunotherapy in patients with recurrent malignant glioma: preliminary results of using autologous whole-tumor vaccine plus granulocyte-macrophage colony-stimulating factor and adoptive transfer of anti-CD3-activated lymphocytes. Sloan AE, Neurosurg Focus. 2000 Dec 15;9(6):e9.
    4.  Phase II trial of autologous tumor vaccination, anti-CD3-activated vaccine-primed lymphocytes, and interleukin-2 in stage IV renal cell cancer. Chang AE, et al., J Clin Oncol 21:884-90 (2003)