Northwest Bio suspends patient screening in brain cancer trial

Northwest Biotherapeutics

21/08/2015 18:56

(Adds comment from CEO, details about experimental drug) 
    By Ransdell Pierson 
    Aug 21 (Reuters) - The chief executive officer of 
biotechnology company Northwest Biotherapeutics Inc  NWBO.O  
said on Friday the company has temporarily stopped screening new 
patients for the late-stage trial of its experimental brain 
cancer drug. 
    CEO Linda Powers said in a telephone interview the company 
will issue a statement later Friday explaining the move, just 
months before it had planned to complete patient recruitment for 
the 7-year-old study of the drug, DCVax-L. 
    Screening is the process by which a company ensures that an 
individual seeking to enter a clinical trial meets eligibility 
requirements, such as age and not having had another cancer for 
the last five years. 
    The study, among patients with newly diagnosed brain cancer, 
is being conducted in Germany, the United Kingdom, the United 
States and Canada. When asked whether the suspension of new 
patient screening will take effect in all countries, and whether 
the suspension was being required by health regulators, Powers 
said details would be provided in the planned company statement. 
    "The key question is whether patients are able to continue 
treatment in their trial," Powers said. "And the answer is yes." 
    But the lack of details unnerved many investors on Friday, 
with the company's shares falling as much as 11 percent on 
earlier reports the trial itself had been temporarily halted. 
Shares fell another 5 percent to $7.46 after Powers' comments. 
    The company has previously said that if it were to complete 
recruitment of patients for the study by the end of this year, 
that it hopes to complete the DCVax-L study in 2016. 
    Patients taking DCVax-L in far smaller informal trials, 
along with standard care, lived 2.5 times as long as typically 
seen with patients taking standard treatment alone. 
    But skeptics have questioned whether the favorable results 
can be replicated in the larger ongoing study and some have 
accused the company of over promoting limited favorable data.  
    DCVax-L is among an emerging new crop of immuno-oncology 
drugs that coax the body's immune system to track down and kill 
cancer cells. It harnesses dendritic cells, or master cells of 
the immune system, that give directions to other immune cells 
including t-cells and b-cells, which make antibodies. 
    The treatment is made by isolating a patient's immature 
dendritic cells from blood and combining them in a laboratory 
dish with dozens of antigens, or proteins, from brain tumor 
tissue of the patient obtained in surgery. The mixture is then 
purified and injected back into the patient. 
 
 (Reporting by Ransdell Pierson in New York; editing by Jeffrey 
Benkoe, Bernard Orr) 
 ((ransdell.pierson@thomsonreuters.com; +1-646-223-6030; Reuters 
Messaging: ransdell.pierson.thomsonreuters.com@reuters.net)) 
 
Keywords: NORTHWEST BIO SUSPENSION/