June 19, 2014 / 8:35 PM / 4 years ago

UPDATE 1-Northwest Bio drug for inoperable tumors safe so far -researcher

(Adds hospital comments, background on drug)

By Ransdell Pierson

June 19 (Reuters) - An experimental Northwest Biotherapeutics Inc drug for inoperable tumors has shown no signs of toxicity in an ongoing safety trial being conducted at M.D. Anderson Cancer Center, the trial’s researcher said on Thursday.

“We are testing for toxicity, and we haven’t seen any toxicity” from the drug so far, Dr. Vivek Subbiah, an oncologist who is conducting the DCVax-Direct studies at the prominent Houston center, told Reuters. The trials have been underway since last autumn.

Shares of Northwest Biotherapeutics fell 20 percent earlier on Thursday after other officials from M.D. Anderson criticized the biotech company for releasing partial data from the early-stage trial of the drug.

Investigators at the hospital and at several other research sites are testing whether DCVax-Direct can successfully treat a wide range of solid tumors so advanced or inaccessible that they are deemed inoperable.

The ongoing first phase of the study is focusing on whether the injectable drug is safe. The primary goal of a subsequent Phase II part of the study, if the drug proves safe, would assess whether it can actually shrink or eliminate tumors.

Jim Newman, a spokesman for M.D. Anderson, said Northwest Biotherapeutics had released bits and pieces of data from the ongoing trial in a series of recent press releases that had the potential to provide an inaccurate picture of results from the Phase I/II study.

A company press release issued on June 11 said all nine patients who had received four of the six planned injections “are showing tumor cell death, tumor shrinkage, substantial immune cell accumulation in their tumors and/or stabilization ... of their advanced cancer.”

Details mentioned in the press releases were only partial data from a study that has not been completed, Newman said, adding reliable insights about the drug will not be available until the study is concluded and data are studied “in full context.”

The criticism from M.D. Anderson was first reported on Thursday by columnist Adam Feuerstein of TheStreet.

Leslie Goldman, head of business development for Northwest Biotherapeutics, said the data came from medical files at the clinical trial sites and was provided to the company by a contract research organization managing the study.

“This data is important information for patients and the public, and the company strongly stands behind it,” he said in an emailed statement.

Goldman said the company took extra care to note in its announcements the data was early and partial, “and could become better or worse as more data are collected.”

He said the study is unblinded, meaning researchers are aware which patients are receiving the actual drug, and that companies frequently provide interim data or case studies from such trials.

Company shares plunged to $7.18 on the Nasdaq, from their closing price on Wednesday of $8.97.

Reporting by Ransdell Pierson; Editing by Meredith Mazzilli

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