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There are a few new ways to get treatments approved by the FDA - hopefully the results of the trial will be good enough to convince the FDA to let us get access to this vaccine much sooner than the standard process! I will be at the meeting when they reveal the results - will let you know how it went!
Tibor Keler is senior vice president and chief scientific officer of Celldex.
A research note Tuesday said Celldex Therapeutics, Inc. (Nasdaq:CLDX) probably has accelerated approval in mind as it expands a Phase 2 study against recurrent brain cancer.
Stock in Celldex has risen 7 percent this week on news that based on early evidence of anti-tumor activity in the Phase 2 trial of rindopepimut plus Avastin, an approved drug for the disease, it plans to add another 75 patients to the 95 already enrolled. The new patients will better test the drug candidate’s effects in glioblastoma patients who are resistant to Avastin, it said.
“Patients with GBM who have become refractory to Avastin tend to have very rapid disease progression,” said Thomas Davis, chief medical officer of Celldex in a statement. “Based upon preliminary evidence that rindopepimut may have activity in Avastin refractory GBM, we have decided to expand the refractory group with the hope of better defining possible therapeutic effect.”
He said the Phillipsberg, N.J. drug company, which has its research facility in Needham, Mass., will present the results of the initial 25 Avastin-refractory patients in November.
Howard Liang of Leerink Swann said in a research note that he believes the company is aiming for accelerated approval with the expanded study, noting that “the conduct of the trial will meet regulatory standards for a filing study.”
He also added that “regardless of whether there is enough activity to support accelerated approval, we believe this is encouraging for the ongoing Phase 3 trial in newly diagnosed GBM patients.” The Phase 3 trial is testing rindopepimut added to temozolomide, the standard of care, in 440 newly-diagnosed glioblastoma patients.
Leerink Swann’s price target for Celldex remained at $28 a share, higher than the $20.26 per share price as of 2 p.m. Tuesday.
