Wednesday morning, the company announced more positive long-term follow-up data from its prior Phase I and Phase I/II clinical trials, in which patients with newly diagnosed Glioblastoma multiforme ("GBM"), the most rapid and lethal type of brain cancer, were treated with NWBT's DCVax-Brain personalized immune therapy.
The data through July 1, 2010, shows that no patients died during the 9-month period since the last data update (through September 2009). The data also show that median survival was 3 years, 33% of the patients reached 4-year survival, and 27% reached or exceeded 6-year survival (up from 22% who had reached or exceeded 6-year survival as of the last data update). The longest surviving patient to date has now exceeded 10 years.
"We're excited and encouraged by the continued extension of survival in the patients who received DCVax in the prior clinical trials," commented Dr. Al Boynton, NWBT's CEO, "especially since DCVax is non-toxic, unlike chemotherapies, and involves just a simple injection under the skin, like a flu shot."
These results are significant because GBM is one of the top most highly lethal cancers. With standard of care treatment (including surgery, radiation and chemotherapy), patients with newly diagnosed GBM have a median survival of only about 14.6 months, and less than 5% of such patients are still alive at 5 years.
When we told readers that we liked this stock, back in mid-July, shares rose significantly the same day, but the bio-bashers continued to do what they do best and prices retreated. Still, there are few companies, if any, that have been able to show survival statistics like this against brain cancer.
The problem for NWBO has been exposure and money. If they can push their pipeline to the next level, investors and some of the Big Pharmas rumored to be interested in their groundbreaking personalized cancer vaccine technology will be more happy to roll the dice on the company.
In mid June, a very detailed report authored by renowned research pharma analyst Dr. Navid Malik caused some excitement in the pharmaceutical industry. It centered on Northwest's DCVax immunotherapy and Malik, who is well respected in the industry for spotting potential blockbuster drug therapies, wrote very kindly about NWBO. Malik thinks NWBO stands a fairly good chance of delivering on the promise of fully customized immunotherapeutic vaccines tailored for each individual patient and his published opinions led to rumors that several pharmas had contacted the company about possible partnerships or licensing deals.
DCVax-Brain is a groundbreaking personalized vaccine designed to stimulate a patient's own immune system to fight cancer. DCVax-Brain is made up of the patient's own "dendritic cells," the master cells which direct the immune system, that have been activated and "educated" to mobilize the whole immune system to recognize and destroy cancer cells bearing the biomarkers of the patient's own tumor. Each patient undergoes surgical removal of their tumor as part of the current standard of care, and also undergoes a blood draw to obtain their immune cells.
The biomarkers from the patient's tumor tissue are exposed to the patient's immune cells, along with certain other proprietary steps, in order to activate and "educate" the patient's dendritic cells. These activated and "educated" dendritic cells are injected back into the patient, in a simple small injection under the skin in the upper arm, similar to a flu shot or insulin shot. These cell treatments are administered at a series of time points several weeks apart and then months apart. The dendritic cells are then able to mobilize the immune system to recognize and attack the cancer, and do so without toxicities of the kind associated with chemotherapies.
Disclosure: LONG NWBO