Heat Biologics Receives FDA Guidance for Upcoming Trial Meeting

Heat Biologics (NASDAQ:HTBX) received written responses from the US Food and Drug Administration (FDA) following its Type C meeting regarding its planned registrational HS-110 clinical trial design for the treatment of non-small cell lung cancer (NSCLC).
As quoted in the press release:

The discussion focused on elements of proposed clinical trial designs, both single-arm and controlled, which the FDA agreed would be appropriate to support a registrational trial of HS-110. Clinical endpoints and post-marketing commitments were also discussed in the context of accelerated approval.
“We are very pleased with the outcome of our recent Type C guidance meeting with the FDA,” said George Peoples, M.D., Chief Medical Officer for Heat. “The FDA clearly understands the significant unmet need for more effective second-line treatments for NSCLC. We look forward to incorporating their guidance as we prepare to advance HS-110 into registrational trials.”
HS-110 is currently in Phase 2 as a treatment for NSCLC. Trial design details and next steps are expected to be announced following the read-out of the Phase 2 data, anticipated in 2H 2018.

Click here to read the full press release.

Source: www.accesswire.com