TRACON Pharmaceuticals has reported positive results from the National Cancer Institute (NCI) Phase Ib/II clinical trial of TRC105 and Nexavar (sorafenib) to treat patients with hepatocellular cancer (HCC).

TRC105 is a clinical stage antibody to endoglin protein, which is found to be over-expressed on proliferating endothelial cells and is required for formation of new blood vessels.

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The results showed an overall response rate (ORR) of 25% measured by the Response Evaluation Criteria in Solid Tumours (RECIST) and a median overall survival of 15.5 months, both of which were greater than that observed for Nexavar alone in prior trials.

A total of 26 advanced HCC patients were enrolled in the Phase Ib/II trial and were administered TRC105 with either 3, 6, 10mg/kg or 15mg/kg every two weeks in combination with the standard dose of 400mg twice-daily Nexavar.

All responses occurred at the two highest dose levels of TRC105, with the ORR being 33%, and the median progression-free survival (PFS) being 3.8 months.

"The final data from the NCI study of TRC105 and Nexavar in HCC published today reinforce the encouraging preliminary data presented previously at ASCO."

Furthermore, the combination was well-tolerated at the recommended single agent doses of both drugs.

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TRACON Pharmaceuticals president and CEO Charles Theuer said: “The final data from the NCI study of TRC105 and Nexavar in HCC published today reinforce the encouraging preliminary data presented previously at ASCO.

“Collectively, these data suggest that the combination of TRC105 and Nexavar is active in patients with HCC and support the advancement of this combination into further clinical studies.”

TRC105 is being investigated in a Phase III and several Phase II trials sponsored by TRACON or the NCI to treat solid tumours in combination with VEGF inhibitors.

TRACON is currently funding another Phase I/II multi-centre trial of the combination to confirm the NCI-reported activity.

NCI is responsible for enrolment into this trial and the results are expected to be available early next year.

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