TapImmune, Inc.
(TPIV), a clinical-stage immunology-oncology company specializing in
the development of innovative peptide and gene-based immunotherapeutics
and vaccines for the treatment of cancer & metastatic disease,
announced today that it has received Orphan Drug Designation from the
U.S. Food & Drug Administration's Office of Orphan Products
Development (OOPD) for its cancer vaccine TPIV 200 in the treatment of
ovarian cancer. The TPIV 200 ovarian cancer clinical program will now
receive benefits including tax credits on clinical research and 7-year
market exclusivity upon receiving marketing approval.
TPIV 200 is a multi-epitope
peptide vaccine that targets Folate Receptor Alpha which is
overexpressed in multiple cancers including over 90% of ovarian cancer
cells. In Phase I clinical studies conducted at the Mayo Clinic in
patients with breast and ovarian cancer this vaccine was shown to be
safe and well tolerated and to give robust cellular immune responses in
20 out of 21 evaluable patients. Further, the data showed that 16 out
of 16 patients in the observation stage still showed immune responses.
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