It's been five months (!!) since Northwest Biotherapeutics (NWBO) told investors that independent monitors were conducting an interim efficacy analysis of the phase III study of DC-Vax in patients with newly diagnosed glioblastoma multiforme (GBM.) Northwest Bio promised results in February but failed to deliver. It's now May, and still silence.
But Northwest Bio wants to change the subject, hence this morning's press release about a patient "case study" involving use of DC-Vax Direct, the second cancer vaccine in the company's pipeline. Northwest Bio is seeking to capitalize on investors' interest in the upcoming American Society of Clinical Oncology (ASCO) annual meeting, even though the company has no real clinical data to present because the tiny study of DC-Vax Direct is still in its early stages. No worries. Instead of clinical data, Northwest Bio chooses to issue an exploitative story about a cancer patient.
The specific case study announced today involves a sarcoma patient with a large tumor mass and multiple inoperable metastatic tumors in the lung. This patient received the first 3 DCVax-Direct injections through the course of a month, starting in February. He received a fourth injection in early April and then was scanned for results in early May. At that time, this patient's MRI scan showed extensive necrosis and partial collapse of the injected large tumor mass, and a CT scan showed some early indication of shrinkage of one of the non-injected metastasized tumors. These results suggest both local and systemic effects of the DCVax-Direct treatment, as were seen in the pre-clinical studies.
And Northwest Bio promises to issue more "case study" reports on DC-Vax Direct ahead of the ASCO annual meeting. Good to know, guys. Thanks. John Carroll, editor at Fierce Biotech, summed up the situation well this morning:
Touting "case studies" about cancer drugs is grossly unethical. Pandering to a market of dying patients. The stuff of snake oil sales. $NWBO
John Carroll (@JohnCFierce) May 15, 2014
I'm shocked that when you plunge a giant needle four times into a tumor mass, then take a scan of that tumor mass, you find damage. Who could have guessed? For Northwest Bio, this is what passes for science. For everyone else, it's just stock promotion targeting the desperate and gullible.
Where is the interim efficacy analysis of the DC-Vax GBM study? Five month of silence should get regulators wondering about the possibility of trial misconduct.
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