Northwest Biotherapeutics ($NWBO) has begun enrolling patients in a Phase III trial of its controversial dendritic cell-based therapeutic vaccine DCVax-L in Germany.
DCVax-L is meant to be used as an add-on to the standard treatment in newly diagnosed patients. The company has trumpeted the drug's potential and some analysts have been willing to oblige, saying that a successful launch of DCVax-L could propel overall sales in the glioblastoma multiforme drug market from $305 million in 2012 to $583 million in 2019, according to market research.
While the company has heralded individual success stories of patients in a Phase I/II study of DCVax-L living well beyond the expected survival time, critics have said that the data seen so far from a small cadre of patients shouldn't be considered statistically significant because of the trial's size and "informal nature." And TheStreet's Adam Feuerstein has railed against the company, harshly assailing the therapy as little more than a placebo--a position the company has repeatedly rejected.
In March, German health officials granted Bethesda, MD-based Northwest special permission to sell DCVax-L for all glioma brain cancers. Now, the company says its first trial site has opened in Dresden with three more trial sites expected to open this month and another four to open in July.
The news in March that a Phase III trial of Northwest's DCVax-L was on track pleased investors, sending its shares up by as much as 10%. In the midtrial review, Northwest's data monitoring board reviewed safety data and recommended the trial continue despite the omission of still-pending efficacy data.
The most lethal form of brain cancer, glioblastoma multiforme has a maximum overall survival of 15 months with the standard treatment of care--resection surgery, radiation therapy and chemotherapy with Merck's ($MRK) Temodar. For recurrent tumors, patients have the option of Roche's ($RHHBY) Avastin, carmustine and other chemotherapy drugs used off-label. But these only offer limited benefit in extending overall survival, leaving huge unmet need for better treatments.
Other cancer vaccines are also forecast to hit the glioblastoma market by 2019, including Celldex Therapeutics' Rindopepimut and Peregrine Pharmaceuticals' targeted therapy Cotara. But with few other prospects that offer significant overall survival rates, a large need for glioblastoma therapies will likely still remain.
- read the statement from Northwest Biotherapeutics
- get the market report press release