By Lisa Seachrist
WASHIGNTON — CellPro Inc. received an FDA approvable letter Thursday to expand the uses of the Ceprate SC Stem Cell Concentration System to include selection of peripheral blood progenitor cells (PBPC) and tumor purging.
The FDA is prepared to expand the use of the Bothell, Wash.-based company's stem cell selection device under the condition that CellPro submit long-term follow-up data on its completed Phase III trial and data from an ongoing European Phase III study. The agency also will have to approve the device's final labeling.
"We are really excited with the news today," said Mark Handfelt, vice president and general counsel at CellPro. "We are definitely looking for a tumor purging label for this device."
In making its decision, the FDA is following last month's recommendation of its Biological Response Modifiers Advisory Committee. (See BioWorld Today, March 25, 1998, p.1.)
CellPro first received approval for the Ceprate SC Stem Cell Concentration System in December 1996 as a means of processing autologous bone marrow to obtain a stem cell-enriched population for hematopoetic support after myeloablative therapy.
The advisory panel in March supported the device in the pre-chemotherapy selection of peripheral blood stem cells in patients with multiple myeloma who are about to undergo myeloablative chemotherapy. The Ceprate System concentrates progenitor cells, resulting in a smaller number of tumor cells being returned to patients.
Label Still Under Discussion
The FDA's approvable letter doesn't state whether the label will include tumor purging in general, expanding the use of the device to both patients undergoing treatment for multiple myeloma as well as other cancers. That move may convince third-party payers to ante up for stem cell selection in certain situations.
"The breadth and the scope of the label is still under discussion," Handfelt said. "We have provided data to the agency addressing tumor purging in other cancers and hope to have a broad label."
CellPro, however, continues to be involved in a patent dispute over the technology. Baxter International Inc., of Deerfield, Ill., whose Isolex cell-separation system is pending at the FDA, has argued CellPro's product infringes upon patents held by Baxter, Becton Dickinson & Co., of Franklin Lakes, N.J.; and Johns Hopkins University, in Baltimore.
A jury ruled in CellPro's favor, but a U.S. district judge overturned the verdict and agreed with Baxter. The case is now in U.S. Appeals Court and arguments are scheduled to begin May 5 in Washington.
"We believe we have a strong case and are looking forward to being able to argue our case in front of three judges," Handfelt said. "We hope there is a rapid decision in our favor. This patent litigation ties up a huge amount of the value of our stock."
In addition to the patent litigation, the company also is being sued by shareholders as a result of comments made by the district court judge in the patent case.
CellPro's stock (NASDAQ:CPRO) closed Thursday at $3.875 up $0.3125. *