Firm plans to bring the product to market in the third quarter of 2007.
Northwest Biotherapeutics’ (NWBT) reports that it received approval to market DCVax-Brain, a vaccine for the disease, in Switzerland. The company intends to make the product available in the third quarter of 2007. NWBT’s shares jumped over 40% in morning trading to reach a price of $2.95 per share.
“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 today,” says Alton Boynton, Ph.D., president and CEO of Northwest Biotherapeutics. “Switzerland is an attractive place to begin commercialization due to its highly respected regulatory oversight and its growing experience with cellular therapies. Switzerland is also increasingly noted for medical tourism, and is easily accessible for many medical tourists.”
In clinical trials, both newly diagnosed and recurrent brain cancer patients treated with DCVax-Brain had more than double the survival time of patients who did not receive the therapeutic, according to NWBT. In addition, unlike chemotherapy, the vaccine does not cause any debilitating side effects, the company adds.
DCVax products are personalized treatments, made by combining a patient’s dendritic cells with cancer biomarkers derived from or displayed by the patient’s tumor. The vaccines work by mobilizing the full spectrum of immune response, both innate and adaptive, rather than just single immune agents such as antibodies alone or T cells alone.
DCVax-Brain has been granted orphan drug status in the U.S. and the EU. A Phase II pivotal trial is anticipated to conclude around the end of 2008. NWBT’s most advanced program is a Phase III, pivotal study in prostate cancer. DCVax also has received FDA clearance for clinical trials in lung, liver, ovarian, pancreatic, and head and neck cancer.
Unlike many personalized therapies under development, DCVax products will be cost-effective, according to NWBT. The key is a batch manufacturing process under which a single manufacturing run is used to produce at least three years of personalized treatments for a particular patient, the company explains.