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news.Antisense Pharma has released results from its ongoing open-label, multicenter, Phase I/II dose escalation trial with intravenous monotherapy of trabedersen (AP 12009) as a treatment for patients with advanced pancreatic cancer (PanCa), malignant melanoma (MM) and colorectal carcinoma (CRC).
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AP 12009-P001 Phase I/II trial is investigating the safety and tolerability of i.v. administration of trabedersen in 61 patients with advanced solid tumors known to overproduce TGF-b2, who were either not or no longer amenable to established forms of therapies.
The results from the trial suggested that trabedersen is safe and very well tolerated in systemic application – and quality of life is already a crucial factor in validation of new anti cancer drug.
In the trial, the PanCa patients treated 2 nd-line with trabedersen reached a median overall survival (mOS) of 6.9 months which is comparable to best available chemotherapy (mOS 5 – 6 months, historical data).
Additionally, patients treated 2nd-line with the dose 140mg/m2/d demonstrated an encouraging survival benefit: their mOS was 13.4 months – in comparison to best available chemotherapy.
Antisense Pharma chief medical officer Hubert Heinrichs said since there is no approved 2nd-line treatment for PanCa patients in the US and Europe, they are confident that their immunostimulatory medication trabedersen will help to prolong survival in advanced pancreatic cancer patients.
"Based on this very encouraging data we are currently preparing an international randomized, active-controlled Phase II/III study as 2 nd-line treatment in PanCa patients – scheduled to start in 2012," Heinrichs said.