By Randall Osborne
The FDA issued an approvable letter for CellPro Inc.'s second-generation cell-separation device, called the Ceprate SC Instrument II, allowing the company to use it for peripheral blood and tumor purging.
"That's why most people want to use it, quite frankly," said Rick Murdock, chairman and CEO of Seattle-based CellPro. "[The wider label] is something we've been working on for some time."
Murdock said he expects a "quick" approval at the FDA, since the company already has responded to the agency's requests related to final labeling.
"They wanted a lot of engineering data on the differences between the old instrument and the new one," he said.
The original Ceprate SC Stem Cell Concentration System was approved by the FDA in December 1996 to select progenitor cells from bone marrow, purifying them in order to replenish cells damaged by cancer chemotherapy. An expanded label for that system, allowing its use for peripheral blood and tumor purging, won an approvable letter from the FDA in April. Final approval is expected soon.
"Peripheral blood is really the source of most stem-cell transplants these days," Murdock said. "Ninety percent are not from bone marrow but from peripheral blood."
The term "tumor purging" refers to taking tumor cells out of the blood.
Second-Generation System 'More User Friendly'
"We did a Phase III trial to demonstrate reduction in tumor cells in the stem cell graft going back to the patient," Murdock said. "Getting rid of them is an important issue."
CellPro's second-generation system incorporates better software and engineering. "It's more user friendly, more automated, more streamlined," Murdock said. With its existing system, CellPro has treated about 7,000 patients worldwide, he added.
Although CellPro's device is the only FDA-approved stem cell selection system on the market, it faces potential competition. The company is involved in patent litigation related to a similar system being developed by Nexell Therapeutics Inc., a firm jointly owned by Irvine, Calif.-based Vimrx Pharmaceuticals Inc. and Baxter Healthcare Corp., the principal U.S. operating subsidiary of Baxter International Inc., of Deerfield, Ill. (See BioWorld Today, July 9, 1998, p. 1.)
CellPro's stock (NASDAQ:CPRO) closed Monday at $3.437, up $0.312. *