Northwest Bio drug for inoperable tumors safe so far -researcher (updated)

Northwest Biotherapeutics

19/06/2014 21:32

(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  NWBO.O  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) 
 ((ransdell.pierson@thomsonreuters.com)(646 223 6030)(Reuters 
Messaging: ransdell.pierson.thomsonreuters.com@reuters.net)) 
 
Keywords: NORTHWEST BIO SAFETY/