An experimental treatment for brain cancer has won approval for commercial use in Switzerland, its London-listed US maker, Northwest Biotherapeutics, Inc., announced on Monday.
DCVax-Brain will be available to patients in selected hospitals and medical centres in Switzerland before the end of September, the first time a treatment of this kind has been given market authorisation, it said in a statement.
"We are delighted to be the first company to reach the market with a personalized therapeutic vaccine for brain cancers, which carry a very bleak prognosis for patients," said Alton Boynton, president and chief executive of Northwest Biotherapeutics.
DCVax-Brain is designed to treat cancer by priming the patient's immune system to attack cancer cells.
The patient's own master immune cells, known as dendritic cells, are taken from the bloodstream while they are still at an immature stage.
These precursor cells are then matured in a lab dish while being exposed to biomarkers from the patient's own tumour, thus helping them to identify the cancer foe. Once they reach adult stage, the cells are injected back into the patient's body.
DCVax-Brain is currently in the second phase of the typical three-phase process of testing a new drug for safety and efficacy before it is licenced by the US Food and Drug Administration (FDA) and other medical watchdogs. It is being tested on 141 patients in the United States with glioblastoma multiforme, an especially aggressive form of cancer.
The Swiss Agency for Therapeutic Products, known as Swissmedic, decided to approve the company's request for a commercial licence on the basis of ongoing clinical data, Northwest Biotherapeutics said.
Brain cancers are among the swiftest of lethal cancers. Patients with the disease have on average only 14.6 months to live after diagnosis.
Data from the trial showed that patients treated with DCVax-Brain more than doubled this survival time compared to counterparts who did not get the drug, meaning that they had lived to more than 33 months or were still alive at the end of that phase of the trial, the statement said.
In addition, unlike chemotherapy, the drug "does not cause any debilitating side effects," it said.
In addition, the treatment was found to delay recurrence of the disease by nearly three fold, from 6.9 months to 18.1 months among patients who were newly diagnosed.
Boynton said "Switzerland is an attractive place to begin commercialization, due to its highly respected regulatory oversight, and its growing experience with cellular therapies."
He added: "Switzerland is also increasingly noted for medical tourism, and is easily accessible for many medical tourists."