Shares in Heat Biologics (Nasdaq: HTBX) regained some lost value Wednesday after the FDA lifted a “partial clinical hold” on a drug trial. The hold, which was announced last week, triggered a 25 percent plunge in Heat shares.
Heat said it will resume patient enrollment.
“We appreciate the FDA’s expedited review and resolution of this matter as we resume enrollment in our Phase 2 monotherapy trial arm,” said Heat Bio CEO Jeff Wolf in a statement.
“We are encouraged by the positive results reported to-date and believe HS-410 represents a potential treatment option for patients suffering with non-muscle invasive bladder cancer.
“Our clinical timelines remain materially unchanged with topline data expected in the fourth quarter of 2016 for the Phase 2 randomized trial arms evaluating HS-410 in combination with BCG. We are grateful for the ongoing support of the patients and their physicians participating in our clinical trial.”
Shares closed Wednesday at $2.22, up 15 cents or some 7.3 percent.
Earlier in the day, Heat shares sold as high as $2.31.
Even when the hold was announced, Heat said its “timelines” for the treatment “remain materially unchanged.”
“The company anticipates clinical timelines for HS-410 to remain materially unchanged,” Heat stressed in the initial announcement.
The treatment involved, known as HS-410, is in phase 2 clinical trial. Heat completed signups for the trial in October.
The problem is that Heat said the cell line on which the treatment is based had been “previously misidentified.” Heat is focused on treatments that activate a patient’s immune system to fight cancer.
