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In addition to there being no deaths among the DCVax(R)-Brain treatedpatients during the 2008 update period, only two of the twenty patientsexperienced progression (recurrence) of their brain cancer. One of these twopatients had been disease free for nearly 6 years (70 months) at the time oftheir progression, and the other patient had been disease free for more than 4years (50 months). In contrast, the usual time to progression (recurrence) inGBM, with full standard of care treatment but without DCVax(R)-Brain, is only6.9 months.
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DCVax(R)-Brain is a groundbreaking personalized vaccine that takes apatient's own master immune cells and the biomarkers from that patient's owntumor tissue, and activates the master immune cells so they can mobilize thefull immune system to recognize and kill the tumor cells. The 10-daymanufacturing process produces several years of personalized vaccine for apatient, making DCVax(R)-Brain an "off-the-shelf" product for that patientthroughout the treatment period. DCVax(R)-Brain is administered as a simpleinjection under the skin, similar to a flu shot, and is not toxic as mostchemotherapies are.
DCVax(R)-Brain is now in a large Phase II clinical trial which iscurrently enrolling patients at 11 medical centers across the U.S. (listed athttp://www.nwbio.com).
"The long-term survival of patients treated with DCVax(R)-Brain continuesto be quite striking and encouraging," commented Dr. Alton L. Boynton,President and Chief Executive Officer of NWBT, "and it is especially excitingthat this long-term survival is without toxicity, enabling our patients to goon with their lives in a normal fashion."
GBM, the most aggressive form of brain cancer, is estimated to have causedmore than 12,000 deaths in the United States in 2007; and brain cancer isestimated to have caused over 39,000 deaths in Europe in 2002 (in each case,the last year for which estimates are available). Beyond surgery to remove thebrain tumor and radiation therapy, there are only two treatments for GBMpatients currently approved by the U.S. Food and Drug Administration ("FDA"):one chemotherapy drug, and one drug-infused wafer for surgical implant. Thosetreatments have been shown in clinical trials to typically add only 10-12weeks of survival in GBM patients.
Since 2005, the standard of care for patients with newly diagnosed GBM hasbeen surgery followed by a combination of radiation and Temodar(R). Thestudies that defined this standard of care, and formed the basis for theapproval of Temodar(R), achieved a median overall survival of 14.6 months anda median time to disease progression (recurrence) of 6.9 months (Stupp, et.al., N Engl J Med, 352:987, 2005, n = 573).
As noted above, DCVax(R)-Brain is a personalized immunotherapy designed tostimulate a patient's own immune system to fight cancer. DCVax(R)-Brain ismade up of the patient's own "dendritic cells," the master cells of the immunesystem, that have been activated and "educated" to mobilize the full immunesystem to recognize and destroy cancer cells bearing the biomarkers of thepatient's own tumor. Each patient undergoes tumor removal through surgery aspart of the current standard of care. Dendritic cells drawn from a sample ofthe patient's blood are exposed in a lab dish to the biomarkers of thepatient's own tumor, along with certain other proprietary steps, and arethereby activated and "educated." These activated and "educated" dendriticcells are injected back into the patient, in a simple small injection underthe skin, similar to a flu shot or insulin shot, at a series of time pointsseveral weeks apart and then months apart. These dendritic cells are then ableto mobilize the immune system to recognize and attack the cancer, and do sowithout toxicity to the patient (i.e., without grade 3 or 4 adverse events).
About Northwest Biotherapeutics
Northwest Biotherapeutics is a biotechnology company focused on developingimmunotherapy products that treat cancers more effectively than currenttreatments, without toxicity, on a cost-effective basis. The Company has twobroad platform technologies: dendritic cell-based vaccines and therapeuticantibodies. The Company is currently conducting a large Phase II clinicaltrial in GBM, which is currently open and enrolling patients at 11 sitesacross the U.S. The Company has also received clearance from the FDA for alarge Phase III trial in prostate cancer, and clearance from the FDA for PhaseI trials in five other cancers. The Company has started, and is currentlyenrolling patients in, a Phase I/II trial with DCVax(R) for recurrentmetastatic ovarian cancer. The Company's second technology platform, involvingantibodies to CXCR4, is at the late pre-clinical development stage.
For further information about clinical sites and Company informationplease visit the company web site at http://www.nwbio.com.
Disclaimer
Statements made in this news release that are not historical facts,including statements concerning future treatment of patients with GBM usingDCVax(R)-Brain and future clinical trials, are forward-looking statementswithin the meaning of the Private Securities Litigation Reform Act of 1995.Words such as "expects," "believes," "intends," and similar expressions areintended to identify forward-looking statements. Actual results may differmaterially from those projected in any forward-looking statement.Specifically, there are a number of important factors that could cause actualresults to differ materially from those anticipated, such as the Company'sability to raise additional capital, risks related to the Company's ability toenroll patients in its clinical trials and complete the trials on a timelybasis, the uncertainty of the clinical trials process, uncertainties about thetimely performance of third parties, and whether the Company's products willdemonstrate safety and efficacy. Additional information on these and otherfactors, which could affect the Company's results, is included in itsSecurities and Exchange Commission ("SEC") filings and the Risk Factorssection of the Form S-1 recently filed by the Company. Finally, there may beother factors not mentioned above or included in the Company's SEC filings orrecently filed Form S-1 that may cause actual results to differ materiallyfrom those projected in any forward-looking statement. You should not placeundue reliance on any forward-looking statements. The Company assumes noobligation to update any forward-looking statements as a result of newinformation, future events or developments, except as required by securitieslaws.In other results from the 2008 update data period: -- 95% of DCVax(R)-Brain treated patients have lived longer than the median survival of 14.6 months with existing standard of care treatment; -- Likewise, 95% of DCVax(R)-Brain treated patients have been free of disease progression (recurrence) for longer than the median progression free survival of 6.9 months with existing standard of care treatment.
SOURCE Northwest Biotherapeutics, Inc.
