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Northwest Biotherapeutics (NWBT) Announces That Another Brain Cancer Patient From Phase I/II DCVax®-L Trials Has Surpassed Ten-Year Cancer-Free Survival



4/18/2013 9:59:47 AM

BETHESDA, Md., April 18, 2013 /PRNewswire/ -- Northwest Biotherapeutics (NASDAQ: NWBO) (NW Bio), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced today that Brad Silver, an All American swimming and water polo athlete who was diagnosed with Glioblastoma multiforme (GBM) brain cancer in late 2002, and was treated with DCVax-L in March of 2003, just celebrated the 10th anniversary of his continued cancer-free survival.

(Logo: http://photos.prnewswire.com/prnh/20110329/SF73084LOGO)

GBM is the most aggressive and lethal form of brain cancer. With today's standard of care (surgery, 6 weeks of daily radiation to the brain plus daily chemotherapy, followed by monthly chemotherapy), this cancer typically recurs within 7 months and kills within 14.6 months. Without all these treatments, GBM typically kills within months of diagnosis.

When Brad was diagnosed, he was told by his doctors that he had only about 2 months to live.

Brad is now the second patient from the Phase I/II trials with DCVax-L for GBM who has surpassed the 10-year cancer-free survival mark. The first such patient has further passed the 11-year cancer-free mark.

Beyond these two 10-plus year survivors, the long-term follow-up data on the other patients from the Phase I/II trials shows a "long tail" of survival among them. The median survival of GBM patients treated with DCVax-L was 3 years (in contrast to only 14.6 months median survival with standard of care). The "long tail" also stretched significantly further, beyond this median: 33% of the patients reached or exceeded 4 years of survival, and 27% of the patients reached or exceeded 6 years of survival (in contrast, only 3% or so of GBM patients are still alive at the 5-year mark with standard of care treatments). Several of these patients are continuing to move through further years of survival.

"When I was told I had several months left to live in 2002, with my wife several months pregnant, I was determined to find a clinical trial that would allow me to see and raise my son," commented Brad Silver. "When that quest led me to DCVax and Dr. Linda Liau at UCLA, the natural renewal of my own immune system made more sense to me than just a continuation of the system-wide poisoning of chemotherapy. And it worked. Not only did the tumor disappear and stay away for all this time, but the only side effect I had was unbridled happiness and a new freedom. My son Brad II, who was born 10 days after my first DCVax treatment, will be 10 years old next week, and today I am there for my family thanks to DCVax."

Brad is not just in continuing remission, he is also a very hardy physical specimen. While he was a long-time resident of Ohio, Brad coached women's water polo at an NCAA division II College in Ohio. He is currently living abroad with his wife on a project assignment, and teaches swimming, physical education and sailing, and guides kayak tours. For fun he is an avid surfer.

Brad tells his inspiring story in his own words in an interview last year, with a short excerpt on YouTube at http://www.youtube.com/user/NWBioNWBO/featured.

NW Bio is currently conducting a 312-patient Phase III, double blind, randomized, placebo- controlled clinical trial with DCVax-L for GBM brain cancer using the same DCVax-L vaccine that Brad Silver received. This trial currently has 44 active sites across the US, and nearly 30 additional sites in varying states of preparation in Europe.

"We are thrilled to see Brad become our second GBM patient to pass the 10-year cancer-free milestone after treatment with DCVax-L," commented Linda F. Powers, CEO of NW Bio. "With 'state of the art' treatments today, 10-year survival in GBM is unheard of. Indeed, even survival half that long is virtually unheard of. The "long tail" of survival among a large percentage of our patients is a particularly compelling aspect of our DCVax technology."

"Our hat is off to Brad and his family for their courage and trail blazing role in helping demonstrate the potential of DCVax-L for more patients in the future," Ms. Powers continued. "Brad's example reinforces our own determination to bring DCVax to other patients as soon as possible."

About Northwest Biotherapeutics

Northwest Biotherapeutics is a biotechnology company focused on developing immunotherapy products to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis, in both the United States and Europe. The Company has a broad platform technology for DCVax dendritic cell-based vaccines. The Company's lead program is a 312-patient Phase III trial in newly diagnosed Glioblastoma multiforme (GBM). GBM is the most aggressive and lethal form of brain cancer. The Company also previously received clearance from the FDA for a 612-patient Phase III trial in prostate cancer, and clearance from the FDA for Phase I/II trials in multiple other cancers. The Company also conducted a Phase I/II trial with DCVax for metastatic ovarian cancer together with the University of Pennsylvania.

Disclaimer

Statements made in this news release that are not historical facts, including statements concerning future treatment of patients using DCVax and future clinical trials, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "expect," "believe," "intend," "plan," "continue," "may," "will," "anticipate," and similar expressions are intended to identify forward-looking statements. Actual results may differ materially from those projected in any forward-looking statement. Specifically, there are a number of important factors that could cause actual results to differ materially from those anticipated, such as the Company's ability to raise additional capital, risks related to the Company's ability to enroll patients in its clinical trials and complete the trials on a timely basis, the uncertainty of the clinical trials process, uncertainties about the timely performance of third parties, and whether the Company's products will demonstrate safety and efficacy. Additional information on these and other factors, including Risk Factors, which could affect the Company's results, is included in its Securities and Exchange Commission ("SEC") filings. Finally, there may be other factors not mentioned above or included in the Company's SEC filings that may cause actual results to differ materially from those projected in any forward-looking statement. You should not place undue reliance on any forward-looking statements. The Company assumes no obligation to update any forward-looking statements as a result of new information, future events or developments, except as required by securities laws.

SOURCE Northwest Biotherapeutics


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