TetraLogic Pharmaceuticals
Corporation TLOG today announced that it intends to proceed with the
expansion phase of its study in patients with ovarian cancer. The study is
being conducted in patients who have failed up to three rounds of prior
chemotherapy. In the study birinapant has been dosed twice weekly, 3 weeks out
of 4, or 4 weeks out of 4, in combination with Amgen's TRAIL receptor 2
agonist antibody, conatumumab, dosed every 2 weeks. Patients are scanned for
disease status after every 8 weeks (2 cycles).
To date eighteen patients have been dosed in the Phase 1b portion of the
study. Results thus far suggest a pharmacodynamic interaction between the two
drugs, manifested as the appearance of adverse events at lower than
anticipated doses. In addition, one patient showed a partial response and two
patients have maintained stable disease, one through four cycles of treatment,
and one through two. Three additional patients are on study awaiting scans.
Following a review of the data with the investigators, the recommendation is
to continue the study, but to reduce the dose of birinapant and to limit
dosing to 3 weeks out of 4. TetraLogic intends to continue the study until
approximately thirty patients have been enrolled.
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