On June 21, 2016 TapImmune,Inc. (TPIV), a clinical-stage immuno-oncology company specializing in the development of innovative peptide and gene-based immunotherapeutics and vaccines for the treatment of cancer & metastatic disease, reported reaching a major milestone of dosing its first patient in a Phase 2 trial for triple negative breast cancer with its cancer vaccine TPIV 200 (Press release, TapImmune, JUN 21, 2016, View Source [SID:1234513485]). Schedule your 30 min Free 1stOncology Demo! The first patient enrolled is being treated at the University of Maryland – one of 8 sites being used in this study, conducted and funded by TapImmune.
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The randomized, open label Phase 2 study is expected to enroll a total of 80 subjects. The primary endpoints are dosing regimens and safety. Secondary endpoints are T-cell specific responses and evaluation of objective responses.
Dr. Glynn Wilson, Chairman and CEO of Tapimmune stated, "Enrolling and treating this first patient represents the start of a robust and intensive Phase 2 clinical program for our lead product TPIV 200, a Folate Receptor Alpha T-cell vaccine."
TPIV 200 is currently being investigated in two other Phase 2 trials at the Mayo Clinic and at Memorial Sloan Kettering.
"Enrollment has started in the Phase 2 40 patient study at Memorial Sloan Kettering in collaboration with Astra Zeneca in late-stage ovarian cancer. In addition, the large 280 patient Phase 2 trial being run at the Mayo Clinic with a grant from the Department of Defense is expected to start enrollment later this year," Dr. Wilson added.
TapImmune has received Fast Track Status and Orphan Drug Designation for TPIV 200. The Company plans to initiate a fourth Phase 2 clinical study, in late 2016, designed to treat platinum-sensitive ovarian cancer patients.
"The clinical strategy for TPIV 200 is designed to examine the potential for this exciting T-cell vaccine in as many clinical settings as possible using the most cost-effective pathways. We are excited by the potential for this drug candidate and believe positive data from the Phase 1 study will be reflected in the results of our ongoing Phase 2 clinical investigations," Dr. Wilson concluded.
Interested investors in TapImmune’s clinical studies can learn more by going to: View Source
About Triple Negative Breast Cancer
Triple-negative breast cancer refers to any breast cancer that does not express the genes for estrogen receptor (ER), progesterone receptor (PR) or Her2/neu. Currently the most successful breast cancer treatments target these three receptors, which are lacking in triple negative breast cancer, thus making this sub-type of breast cancer more difficult to treat. This kind of breast cancer can also be more aggressive and more likely to recur than other types of breast cancer. Triple-negative breast cancer accounts for approximately 15%-25% of all breast cancer cases.