NW Bio Offers 'Promising Survival Data' in 51 GBM Patients Treated with DCVAX-L: Data Demonstrated Substantially Longer-Than-Expected Survival


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Northwest Biotherapeutics, Inc.(NASDAQ: NWBO) ("NW Bio"), a biotechnology company developing DCVax®personalized immune therapies for cancer, announced today that Dr. MarnixBosch, the Company's Chief Technical Officer, presented encouraging survivaldata on 51 Glioblastoma multiforme (GBM) brain cancer patients treated withDCVax®-L. The data showed substantially longer than expected survival inpatients with apparent early progression (recurrence) of their cancer,including patients with such aggressive cancer that the tumor was alreadyre-growing by the end of 6 weeks of daily radiotherapy and chemotherapy aftersurgical removal of the original tumor. Northwest Biotherapeutics Logo.As previously announced, Dr. Bosch's presentation was made at the 2^ndImmunotherapy of Cancer (ITOC) Conference in Munich, Germany, yesterday andwas webcast. The webcast of the presentation, entitled "Prolonged Survival InPatients With Recurrent GBM Who Are Treated With Tumor Lysate-PulsedAutologous Dendritic Cells," can be seen for up to 30 days athttp://nwbio.com/webcasts/ The presentation poster can be found on theCompany's website.The 51 GBM patients were treated in an Information Arm outside the Company'sPhase III clinical trial because they were not eligible for the trial, due toevidence of early tumor re-growth following 6 weeks of daily radiotherapy andchemotherapy which are standard of care. Overall Survival data is availablefor all 51 patients; however, MRI images are only available for 46 of the 51patients. These 46 patients were classified by an independent medical imagingcompany into 3 groups, as follows. The other 5 patients remainedunclassified, due to lack of available images. o 20 Rapid-Progressor Patients: Patients with a new lesion ≥ 1 cm. in size, or tumor growth of ≥25% both at a Baseline Visit and at Month 2 thereafter; o 25 Indeterminate Patients: Patients with evidence of progression at the Baseline Visit (rendering them ineligible for the trial), followed by stable disease, modest progression and/or modest regression (or unclear tumor measurements), neither of which is enough to classify them as either a Rapid-Progressor or a Pseudo-Progressor; o 1 Pseudo-Progressor: A patient whose Month 2 image showed resolution of most of the prior appearance of tumor growth that had been seen at the Baseline Visit.The prognosis for Rapid Progressor patients is especially poor: their medianOverall Survival is only about 8 to 10 months, according to publishedscientific literature, and they generally are not expected to respond much toany treatments. There is no established benchmark for Overall Survival of theIndeterminate Patients, however, they can be compared to the generalpopulation of GBM patients, for whom median Overall Survival is 14.6 months.The survival to date, for each of these groups of Information Arm patientstreated with DCVax-L, is as follows: o Overall: The median OS of the group of 51 Information Arm patients as a whole is 18.3 months. About 30% of the patients (15 of the 51) lived beyond 2 years, and most of these patients (12 of the 15) remain alive. o 20 Rapid-Progressors: The median OS among these 20 DCVax-L treated patients is 15.3 months (with patients surviving as long as 37.1 months), compared to expected median OS of 8.3 - 10.8 months with existing treatments, based on published literature on comparable patient populations -- a 50% improvement over the expected survival time. Further, one-third of these patients (7 of the 20) lived beyond 18 months – a doubling of the expected survival time with existing treatments. o 25 Indeterminate Patients: The median OS among these DCVax-L treated patients is 21.5 months (with patients surviving as long as 40.7 months), compared to median OS in the general population of newly diagnosed GBM patients of 14.6 months – a 50% improvement over the expected survival time. Further, 9 of these 25 patients remain alive today at more than 24 months, 6 of these 9 patients have exceeded 30 months, and 4 of these 9 patients have reached 35-40+ months. o 1 Pseudo-Progressor: This patient is still alive, with OS of 30.1 months to date. o 5 Unclassified Patients: The median OS is 9.2 months (with patients surviving as long as 30.1 months).As reflected in these data, both Rapid-Progressor Patients and IndeterminatePatients (as well as the Pseudo-Progressor Patient) treated with DCVax-L inthe Company's Information Arm are surviving substantially longer than wouldbe expected based on clinical experience reported in the literature.DCVax-L also continues to show an excellent safety profile, with no seriousadverse events observed in these Information Arm patients. "We are quite encouraged to see survival times in our DCVax-L treatedInformation Arm patients that exceed the expected survival times with existingtreatments by 50% or more," commented Linda Powers, CEO of NW Bio. "Thissurvival data, which has been collected by the independent CRO managing ourPhase III trial, provides an encouraging insight into the potential results ofthe DCVax-L treatments for newly diagnosed patients in the Phase III trial. The survival data also reinforce the results we have seen with extendedsurvival in our prior Phase I/II trials, and reinforce NW Bio's position as aleader in immune therapies for cancer."

20-Year Pro Trader Reveals His "MoneyLine"

Ditch your indicators and use the "MoneyLine". A simple line tells you when to buy and sell without the guesswork. It’s a line on a chart that’s helped Nic Chahine win 83% of his options buys. Here's how he does it.


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