The company has won US approval to start a Phase III trial of Multikine, a mixture of naturally-derived cytokines, in advanced primary (previously untreated) head and neck cancer patients.
The company maintains that the drug could become a blockbuster with sales potential in excess of $1bn – a view that was by MedAdNews last year in its 8th Annual Report on Future Blockbusters.
But Cel-Sci needs to raise funds via a financing or partnership before it can move ahead with the clinical programme, and is having to cut costs to save cash. Raising money “by offering contract manufacturing services to the pharmaceutical industry in its new manufacturing facility” is one approach under consideration.
At the moment the company is burning through its cash reserves, spending just over $4m on R&D in the year ended September 30, 2008, and is largely dependent upon the proceeds from the sale of its securities to meet all its liquidity and capital resource requirements.
The company said it will operate at “significantly reduced cash expenditure levels” for the time being, which will allow it to eke out its reserves through January 2010.
In October 2008, Cel-Sci took delivery of a 73,000-sq. ft. manufacturing facility in Baltimore that has been refitted to produce clinical and future commercial supplies of Multikine at a cost of around $2.4m. That plant will cost the firm around $1.5m a year to lease.
While many small biotech operations choose to outsource manufacturing rather than build their own facility, Cel-Sci’s view has been that it is preferable to maintain close control of manufacturing processes.
“Good and consistent manufacturing and process control is critical and is best assured if the product is manufactured and controlled in the manufacturer's own facility by its own specially trained personnel,” said the company.
It is also keen to use the same facility to make clinical supplies as well as commercial batches – something that is preferred by regulatory authorities.
As of December 31, 2008, the biotech had 30 employees. Nine employees are involved in administration and 21 employees are involved in manufacturing.