Our Phase III trial has been designed to remove many of the common clinical trial problems. We have identified the most common reasons for Phase III study failures or failure to receive approval to sell a drug, other than the drug not working, and they are:
1. Phase III study not reviewed by FDA and not acceptable to FDA:
Our Phase III study was reviewed in detail, and we have made changes
based on FDA's comments prior to commencement of the Phase III
2. Study too small:
Our study will enroll about 800 patients, a very sizeable number.
3. Clinical endpoint not relevant:
We follow overall survival of the patients, the gold standard. The
Clinical endpoint cannot be more relevant.
4. Change in treatment protocol between Phase II and Phase III without
We have made no such changes. Therefore, we expect the Phase II
results to be representative of the results one can expect in the
Phase III trial.
5. Insufficient attention to manufacturing issues:
We have validated our manufacturing process and built a dedicated
manufacturing facility for Multikine.
We believe that the success of this study will open cancer therapy to a whole new way of fighting cancer, one that is not toxic and one that works with the body, not against the body. We have high confidence that this study will be successful for the following reasons:
|SOURCE CEL-SCI Corporation|
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