MR. FEURSTEIN IS MISLEADING
OK, let’s assume what Adam Feuerstein wrote on his blog is correct. “Assuming all 42 patients could have been treated with mela-t, the manufacturing success rate in the phase II study was 22% and median manufacturing time was almost 7 months. Dismal. In fact, 20 patients died waiting for their mela-T to be manufactured.”
In effect, Mr. Feuerstein is predicting that PCT methodology will be just as dismal. Perhaps in any other lab than that of PCT this would be true. However, I am positive that Mr. Feuerstein is no expert in stem cell production.
Mr. Feurstein also adds, “You're right if you suspect making Mela-T isn't easy. Researchers in the study started with 188 melanoma samples, but only 78 adequate cell cultures were grown -- a 41.5% success rate. It took a median of 3.1 months to grow these cancer cells.”
Was median manufacturing time 7 months or 3.1 months? Mr. Feuerstein makes no attempt to explain the discrepancy.
OK, let’s accept that manufacturing these dendritic cancer influenced stem cells, a.k.a. mela-t cells as Mr. Feurstein calls them, is difficult, but not necessarily at PCT. When 42 patients were randomized and studied, using mela-t stem cells where median production time was 3.1 months, results were off the charts in effectiveness with a p=@.001. With a statistical significance of this order, one does not need a large patient pool as Mr. Feurstein complains was not the case.
So really the challenge comes down apparently to NBS being able to manufacture these cancer antigenic dendritic stem cells, i.e. mela-t cells, with a mean production time of 3.1 months or less. We know this is possible because in the P2 study that was the case. Can NBS do this? Of course, it can; it was already done in the P2 study. It would be folly otherwise of NBS to embark upon an estimated expenditure of 25 million dollars to conduct P3 studies using “meta-t” stem cells for Stage 3-4 metastatic melanoma unless PCT staff felt a shorter production time was feasible.
One thing I know for certain is that Mr. Feuerstein is not knowledgeable in stem cell manufacturing and furthermore his logic in presenting his arguments was largely illogical.
