Contract manufacturing services:
We recently completed our $22 million manufacturing facility. During the next 3 months, it will be validated for clinical supplies and readied for contract manufacturing. This facility was built to manufacture Multikine for the Phase III trial and sale thereafter. Due to the unique requirements for Multikine, we have developed over the last 10 years a cold fill at this facility which is not available for contract manufacturing anywhere else. This means that we can fill our Multikine into vials in a completely sterile manner not only at room temperature, as everyone else does, but also at 4 degrees Centigrade. For Multikine, this is a critical step since long exposure to room temperature not only "kills" the biological activity of the investigational product, but may also alter the ratios of the biologically active components and therefore change Multikine. Similar needs exist for every other biologic, including stem cell-derived products and biosimilars. Our 4 degree Centigrade cold aseptic fill will be offered to the industry as a contract service. I leave you with one simple thought: how would your life be affected if you did not have a refrigerator or freezer? We believe that the 4 degree Centigrade cold aseptic fill has the same kind of impact on the pharmaceutical/biotechnology drug industry.
Multikine cancer therapy:
We believe that the most critical step the company can take is to enter the pivotal Phase III clinical trial to support marketing applications for Multikine. In published studies, Multikine has been shown to be non-toxic, to increase survival by 33%, and to eliminate the tumor in 12% of the patients after only a 3-week treatment. The recent success of Dendreon with its prostate cancer vaccine has shown that it is possible to stimulate the immune system of cancer patients to increase survival. Dendr
|SOURCE CEL-SCI Corporation|
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