Cell Therapeutics' Opaxio Data Not Terrible: BioBuzz

SEATTLE, Wash. (TheStreet) -- Please, I want it noted that I did not wake up in the middle of the night to write about Cell Therapeutics(CTIC Quote) today. Twelve hours have passed since the company issued its press release on the results of a phase II study of Opaxio in esophageal cancer.

The Opaxio data presented were pretty good, even though the phase II study was small (40 patients) and lacked a control arm. (Why can't more drug companies run controlled phase II studies!) Patients with esophageal cancer were treated with a combination of Opaxio, cisplatin (a chemotherapy drug) and radiation. Eight of the first 28 evaluable patients, 28.5%, reported a complete response. No patients to date have required a feeding tube.

This "neoadjuvant" treatment regimen was administered to patients in an attempt to shrink tumors before surgery, thereby making it more likely that doctors can remove the tumor entirely, or at least more of it.

Are the data good enough to pencil in Opaxio's approval? Not yet. Sorry. Search the medical literature and you will find plenty of studies reporting equally promising results using chemotherapy cocktails as a neoadjuvant treatment for patients with esophageal cancer.

To cite just one example, here's a study of paclitaxel, cisplatin and radiation, also enrolling 40 patients, which demonstrated a 29% complete response rate. Two patients, or 5%, required the insertion of a feeding tube.

The challenge for Cell Therapeutics is to show that Opaxio is superior in some way -- efficacy or safety -- to a similar neoadjuvant regimen, especially since paclitaxel (the Opaxio precursor) is generic and cheap.