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Northwest Biotherapeutics Receives FDA Clearance for Lung Cancer Trial Thursday September 7, 7:30 am ET Personalized Vaccine Cleared for Phase I Trial in Lung Cancer, the Leading Cause of Cancer Deaths Worldwide
BOTHELL, Wash., Sept. 7 /PRNewswire-FirstCall/ -- Northwest Biotherapeutics, Inc. (OTC Bulletin Board: NWBT.OB - News) today announced that it has received FDA clearance to proceed with Phase I clinical testing of its personalized therapeutic cancer vaccine, DCVax®-LB, in non-small cell lung cancer. The clinical endpoints of the trial will be progression-free survival (i.e., delay in progression of the cancer) and overall survival.
ADVERTISEMENT DCVax®-LB is an extension of the promising DCVax® personalized cancer vaccine that has already shown significant delay in disease progression and in extension of survival in clinical trials in two other cancers: Glioblastoma multiforme (primary brain cancer) and prostate cancer. DCVax® is a therapeutic vaccine, which is used to treat patients who already have cancer. DCVax® is a personalized treatment: it is made from a patient's own dendritic cells that have been "educated" to teach the immune system to recognize and kill cancer cells bearing the biomarkers of the patient's tumor.
"The same DCVax® platform can be used for the treatment of many different tumor types, since it incorporates all of the biomarkers from the patient's tumor," stated Dr. Alton Boynton, President of Northwest Biotherapeutics. "DCVax®-LB offers several key advantages over existing FDA-approved treatments. To date, DCVax® product candidates have shown no toxicity, and have been compatible with other standard therapeutic regimens, including chemotherapy and radiotherapy. In addition, clinical data on delay in disease progression and extension of survival in brain and prostate cancer to date are remarkable."
Lung cancer deaths in the US alone are over 160,000 per year as compared to 30,350 deaths per year for prostate cancer. Existing treatments for non-small cell lung cancer include surgery and radiation therapy, which are used in various combinations. These treatments have significant adverse side effects, and have had little effect on survival. Likewise, chemotherapies used in lung cancer have been highly toxic and have had little effect on survival. In its most recent study, the National Institutes of Health reported that the five-year survival rate for non-small cell lung cancer patients was only 6.2% during 1989-1996. Following initial treatment, virtually all cases of this cancer recur, with a life expectancy of only about one year following recurrence. No effective therapy exists for these patients today.
-------------------- Gagged n Burried!!! Posts: 135 | Registered: Aug 2006
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no clue 10.. saw the news.. saw the charts.. saw that selling could be minimal since yesterdays volume was realy dry.. and it had run to 0.55 previously on some news.. so I got in at 0.3..
-------------------- Gagged n Burried!!! Posts: 135 | Registered: Aug 2006
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I've been watching this for a while. Approval to begin clinical trials isn't really that big of an event.
Now, when you have Phase III clinical results that are very encouraging, that is when it flies. I tried to take some profits on that last .55 runup, but it only lasted about 20 minutes and I was left out.
Hope I'm wrong, but .32 is prolly the HOD.
GLTA
Posts: 129 | From: Columbia, SC, USA | Registered: Oct 2004
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posted
I've been watching this for a while. Approval to begin clinical trials isn't really that big of an event.
Now, when you have Phase III clinical results that are very encouraging, that is when it flies. I tried to take some profits on that last .55 runup, but it only lasted about 20 minutes and I was left out.
Hope I'm wrong, but .32 is prolly the HOD.
GLTA
Posts: 129 | From: Columbia, SC, USA | Registered: Oct 2004
| IP: Logged |
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