NorthWest Biotherapeutics Inc (NWBO)

[CherryTree1]

Here is a link to some detailed info on DCVAX Prostate for you Gary
https://s27.q4cdn.com/906368049/files/December%2012,%202011_NWBO_Initiation%20Report_Zeng.pdf

DCVax-Prostate targets hormone independent (late stage) prostate cancer. DCVax-Prostate combines theCompanysDCVax platform with the cancer-associatedantigenprostate specificmembraneantigen(PSMA). PSMA is located on the surface of prostate cells. It is expressed at very low levels on benign or healthy prostate cells, and at much higher levels on prostate cancer cells. Because PSMA is over-expressed in virtually all prostate cancers, it represents an effective target for prostate cancer therapeutics. DCVax-Prostate is designed to be used in the whole patient population; therefore, the Company does not need to screen patients. In contrast, the use of other cancer vaccines in development may be limited to part of the patient population and require screening of patients.Northwest completed a Phase I/II clinical trial for DCVax-Prostate to treat late-stage prostate cancer patients for whom hormone therapy was no longer effective(initiated in 1999). This trial, which was carried out at the M.D. Anderson Cancer Centre and at UCLA, involved the administration of DCVax-Prostate to 33evaluable patients with non-metastatic and metastatic hormone independent prostate cancer in order to establish the safety of three different dosage levels of DCVax -Prostate.Of a total of 33patients who have been treated in this trial, 11 were non-metastatic hormone independent prostate cancer patients (group A)and 22 were metastatic hormone independent prostate cancer patients (group B). In group A (hormone independent patients without metastasis), there has been an increase in survival from 36months for the natural course of the disease to >54months for DCVax-Prostate treated patients. The median had not yet been reached as of the end of 2005 (the latest date to which long-term data is so far available). In this group the time to metastases under the natural course of the disease is 28 to
Zacks Investment Research Page 11 scr.zacks.com34weeks. This time was lengthened to 59weeks in patients who received DCVax -Prostate. In group A, none of the 11patients had progressed at 28weeks and only five had progressed at 59weeks. The group A patient population is the patient population in planned PhaseIII clinical trial.Currently, there is no FDA approved treatment for non-metastatic home independent prostate cancer patients. Natural Course of DiseaseDCVax-ProstateMedian Time to Disease Progression28-34 weeks59 weeks Median Survival36 months> 54 months. In group B (hormone independent patients with metastases), there was an increase in median overall survival from 18.9months for standard of care to 38.7months for DCVax-Prostate treated patients.Patients in this study had a six-times greater chance of being alive at 36months compared to patients treated with the standard of care.DCVax -Prostate has been shown to elicit a specific PSMA antibody response and a specific and strong T-cell response in about 80percent of patients. In contrast, many cancer therapeutics elicit a clinical response in only a small fraction of patients. DCVax-Prostate also comparesfavorablywithDendreonsProvenge. DCVax-Prostate had a median survival of 38.7 months in NWBOsPhaseI/IItrialcompared to 25.9 months for ProvengeinDendreonsPhase III trials. Three-year overall survival for DCVax-Prostateis64%vsProvenges33%.Standard of Care (Taxotere)DCVax-ProstateProvengeMedian Survival18.9 months38.7 months25.9 monthsOverall Survival (3 years)11%64%33%The Phase I/II clinical results are encouraging. Based on these positive data, DCVax-Prostate wascleared by the FDA for a PhaseIII clinical trial in about 600patients in January 2005. The patient population is non-metastatic hormone independent prostate cancer. The Company currently intendsto separate the 600patient PhaseIII trial into two PhaseIII clinical trials in non- metastatic hormone independent prostate cancer patients with about 300patients per trial.Due to large expenses associated with the Phase III study, the Company is looking for partners to conduct the Phase III trial