SOURCE: BioMedReports

BioMedReports

January 24, 2011 09:46 ET

Northwest Biotherapeutics Back in the Game Following Key Phase II Trial Announcement

LOS ANGELES, CA--(Marketwire - January 24, 2011) - This morning, Northwest Biotherapeutics (OTCBB: NWBO) announced they are resuming enrollment of into its ongoing 240-patient, double blind, randomized, placebo controlled Phase II clinical trial of DCVax for Glioblastoma multiforme ("GBM") brain cancer.

The news may be perceived as a game changer for the stock which has been reflecting some trepidation on the part of investors who were wondering why the company stopped enrollment at 13 clinical sites across the country. Thirty-three patients had already been enrolled in the trials and continue to be treated with the ground-breaking cancer vaccine.

As it turns out, the trials were stalled when the capital markets began to seize up in 2008 despite the fact that early clinical data was both favorable and promising. In fact, a large percentage of those treated by DCVax have continued to be disease free years after receiving their initial treatment of the drug candidate.

"We never suspended the trial," explained Northwest Biotherapeutics' Chairman of the Board, Linda Powers. "We found and spent the money to keep the trial open and we kept treating those who had already enrolled. During the worst of this Great Recession, we did preserve our resources by not enrolling any new patients on top of the couple dozen patients already enrolled and being treated at our 13 trial sites across the country, in anticipation of continuing our positive clinical results and a broader economic revival."

According to Powers and others familiar with the company's financial structure, those expectations are now being borne out. By raising interim funding from a wide diversity of sources, including both angel and institutional investors, both in the US and abroad, the Company's potential has taken a turn for the better. In fact, many feel that the new investor base has positioned the Company for solid growth as they resume enrollment of new patients for their critical trial.

"Keeping the trial active and open, while putting new enrollment on hold through the worst of the capital nuclear winter so that we could today move out to finish what we started," says Powers. "Through it all, our data have continued to accumulate as some of the most compelling evidence available to date that personalized immunotherapies, like DCVax Brain, hold the potential to be a far more effective, non-toxic, cost efficient, and future standard of care in the treatment of cancer."

Since GBM is a highly lethal cancer with at least 12,000 new cases per year in the US, and at least 40,000 new cases per year worldwide. Some Wall Street observers are wondering if a path towards compassionate use of the drug may be on the horizon now that the trial is back in full force.

In December, BioMedReports reported some chatter involving potential partnerships by way of at least two foreign pharmaceutical companies who have taken an interest in DCVax, which mobilizes the patient's immune system to fight the cancer without toxicity.

Powers would not comment on the rumors except to say: "Our goal is to move as quickly as possible toward commercialization of this easily administered, promising brain cancer vaccine for all of these patients, at a cost well below chemotherapy and other competitive vaccines. We can reach that goal by completing this clinical trial as quickly as possible, and confirming the clinical benefits of DCVax, as seen in our prior clinical trials, in delaying recurrence of patients' tumors and extending patients' survival."

Despite everything, it appears Powers did a commendable job of getting the company back into the game without massive dilution to the shareholders. In fact, she may have positioned NWBO back at the front of the immunotherapy pack with a development pipeline that is taking aim at not only brain cancer, but also looking to capture a much bigger share of the prostate cancer market than Dendreon can serve with their FDA approved therapy, Provenge (sipuleucel-T).

NWBO's DCVax Prostate is waiting in the wings for its own push into late stage clinical trials and we foresee some developments there as well now that the stock is in a much healthier position.

"Given our actual stable of eight different cancers either already in clinical trials or authorized to proceed, our primary challenge will be to stay focused on completing this all important 240 patient brain cancer trial as soon as possible," says Powers. "Once on its way to completion, the Company can then move on to commercialize its prostate vaccine, backed by similarly strong Phase I and II data, and then follow up on the preliminarily successful ovarian Phase I trial and the 5 FDA authorized trials on the other most recurring cancers. This kind of prioritization and focus in execution will be the key to ultimately bringing our current robust pipeline of products to market."

Northwest Biotherapeutics appears to be back in the game and focused on pushing not only their immunotherapy products, but also their company to the next level.

"Most significantly impacting our financial progress has been an improvement in our ability to communicate and spread the word about what we have been doing quietly over the last ten years, in both the lab and the clinic," says Powers "Awareness of DCVax is beginning to increase in both the patient community and the physician community. For example, the physicians at our clinical trial sites report that patients are now coming in and asking specifically for DCVax. A growing number of physicians themselves are also asking about it. 

"In turn, we are now ramping up our effort to raise the awareness about DCVax in the investor community as well. We need to further spread the word about this broad platform technology applicable to most cancers, with very promising and consistent clinical results already shown in Phase I/II trials in three different human cancers, that it is non-toxic, less costly to make and far easier to administer than other treatments. 

"So now we are beginning to catch the attention of a broader range of savvy funding institutions and medical professionals. We have a long way to go and have only just begun, but from here on out you can count on improved communications and outreach to match our superior and proven science."

There is new hope for those who have been supporters of the company's efforts. Consistent and impressive clinical trial results in 3 different cancers, with longer survival data, has transformed some of the patients in the trials themselves into the company's biggest fans. 

"We have a proprietary manufacturing process that makes 3 or more years of vaccine in one manufacturing run, with treatments that are frozen, stored and thawed as needed," explains Powers. "As a result, our costs are substantially lower than both standard chemo and our vaccine competitors to date. Our concentration of dendritic cells is 85%, enabling us to administer the treatment with a simple shot in the arm anywhere a flu shot can be given, with little or no side effects, while others require an I V treatment of much lower concentrations."

In addition to everything else, the company has been authorized by the FDA to proceed on Phase I clinical trials on 5 more major cancers.

Investors interested in learning more about Northwest Biotherapeutics or in accessing BioMedReports' complete database of clinical trials and upcoming FDA decisions can access that information at:

http://biomedreports.com/access-our-exclusive-fda-and-clinical-trials-calendars.html

News developments and live healthcare sector updates are available constantly via twitter at: http://twitter.com/BioMedReports

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