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 CEO Linda Powers said in a telephone interview the company had
halted the screening process just months before it had planned to
complete patient recruitment for the seven-year-old study of the
drug, DCVax-L.
The company said in a statement later on Friday that the trial is
ongoing and enrolled patients are continuing to be treated, but that
screening had been "temporarily suspended while the company submits
certain information from the trial for regulatory review." It said
over 300 patients have been recruited for the study, which has a
total anticipated enrollment of 348 patients.
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. Northwest Biotherapeutics said some social media
comments have noted that the European trial database says there has
been a "temporary halt" of the trial in Germany, but said that
referred only to the temporary suspension of new screening.
"The key question is whether patients are able to continue treatment
in their trial," Powers said. "And the answer is yes."
The company said it anticipates submitting the trial information for
regulatory review within the next couple of weeks.
But the news 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 closed down 21.6 percent
at $6.96 on Nasdaq.
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.
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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; Additional reporting by
Deena Beasley in Los Angeles; Editing by Bernard Orr and James
Dalgleish)
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