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Northwest Biotherapeutics to begin enrolling patients in pivotal DCVax-Brain trial in November
By Jennifer Lanning Drey
Portland, Ore., Oct. 30 - Northwest Biotherapeutics, Inc. plans to begin enrolling newly diagnosed Glioblastoma multiforme patients in a pivotal phase 2 trial of DCVax-Brain in November, company president and chief operating officer Dr. Alton Boynton said at the C.E. Unterberg, Towbin health care conference in New York on Monday.
"We believe we are at the right place at the right time. Cancer vaccines are gaining acceptance," Boynton said.
The primary endpoint for accelerated approval in the 141-patient, randomized pivotal trial will be progression-free survival, and the endpoint for full approval will be overall survival, he said.
The course of treatment will be standard-of-care procedures, including surgery, radiation and chemotherapy, with DCVax-Brain injections at 0, 2 and 4 weeks. Booster injections will be given at 2, 4 and 8 months, followed by maintenance injections twice a year for an additional two years.
The trial will take place at 10 sites in the United States and one European site, Boynton said.
The phase 2 trial is based on two phase 1 clinical trials, which demonstrated that patient survival was more than twice as long for patients receiving DCVax-Brain treatment compared with two current Food and Drug Administration-approved therapies.
Boynton also said on Monday that Northwest Biotherapeutics has streamlined batch manufacturing of DCVax-Brain so that a single manufacturing run can make three years' worth of vaccine.
In addition, the company has begun a booster shot program for survivors in its first two phase 1 clinical trials. Those patients are currently receiving therapeutic injections, he said.
Northwest is a biotechnology company based in Bothell, Wash., that develops immunotherapy products for the treatment of cancer.
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