CellPro Announces Clinical Trial for New B-Cell Depletion Product.SEATTLE--(BUSINESS WIRE)--Feb. 19, 1998--CellPro, Incorporated (Nasdaq: CPRO CPRO Columbia Pike Revitalization Organization CPRO Connecticut Peer Review Organization, Inc. ) announced today that it has received an Investigational Device Exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and from the US Food and Drug Administration to begin clinical trials with its new product, the CEPRATE(R) B-Cell Depletion System. This device will be used with CellPro's current product, the CEPRATE(R) SC Stem Cell Concentration System, to reduce the number of B cells in mobilized peripheral blood used for autologous autologous /au·tol·o·gous/ (aw-tol´ah-gus) related to self; belonging to the same organism. au·tol·o·gous adj. 1. hematopoietic hematopoietic /he·ma·to·poi·et·ic/ (-poi-et´ik) 1. pertaining to hematopoiesis. 2. an agent that promotes hematopoiesis. hematopoietic 1. pertaining to or affecting the formation of blood cells. transplantation in patients with relapsed non-Hodgkin's lymphoma (NHL NHL Non-Hodgkin's lymphoma, see there ). The trial will evaluate the safety and efficacy of B-cell purging combined with a CD34+ cell enrichment of mobilized peripheral blood. Unprocessed autologous stem cell grafts may contain tumor cells that are returned to the patient during the transplant procedure. The CEPRATE(R) B-Cell Depletion System is intended to purge lymphoma tumor cells from the peripheral blood stem cell graft in an attempt to prevent tumor cells from being returned to the patient, and possibly causing a relapse of the patient's disease. The clinical process will involve mobilization of stem cells in peripheral blood using hematopoietic growth factors and chemotherapy. CellPro technology will be used to first deplete de·plete v. 1. To use up something, such as a nutrient. 2. To empty something out, as the body of electrolytes. B cells from the apheresis apheresis (əfĕr`əsĭs), or hemapheresis (hē'məfĕr`əsĭs), any procedure in which blood is drawn from a donor or patient and a component (platelets, plasma, or white blood product, then the B-cell depleted product will be further processed using CellPro's CEPRATE(R) SC System to enrich and concentrate the stem cells. "We are very pleased to begin clinical trials with this new product," said Rick Murdock, President and Chief Executive Officer of CellPro. "If proven to be safe and effective, use of the CEPRATE(R) B-Cell Depletion System may reduce the risk of disease relapse in patients suffering with non-Hodgkin's lymphoma. "These clinical trials" says Murdock, "will allow CellPro to continue development of the immunoselection technology used in the CEPRATE(R) SC System. This product, along with the CEPRATE(R) TCD TCD Trinity College Dublin TCD Chad (ISO Country code) TCD Transcranial Doppler TCD Thermal Conductivity Detector TCD Traffic Control Device TCD Tropical Conservation and Development T-Cell Depletion System, demonstrates the versatility of CellPro's core technology platform. CellPro is the first company to combine positive stem cell selection with tumor purging in a closed system. Development of the CEPRATE(R) B-Cell Depletion System, along with the CEPRATE(R) TCD T-Cell Depletion System, will allow physicians to precisely engineer stem cell grafts for their patients directly at their processing centers." The trial is expected to enroll a total of approximately 25 patients at the Ireland Cancer Center at University Hospitals of Cleveland University Hospitals is a major not-for-profit medical center in Cleveland, Ohio, United States. With 150 locations throughout northeast Ohio, it encompasses a network of hospitals, outpatient centers and primary care physicians. and Case Western Reserve University and the University of Washington Medical Center The University of Washington Medical Center is a nationally renowned hospital located in the University District of Seattle, Washington, USA. It is one of the teaching hospitals affiliated with the University of Washington School of Medicine. The 2007 issue of U.S. in participation with the Fred Hutchinson Cancer Research Center. -0- Comments or forward-looking statements should be understood in the context of CellPro's publicly available reports filed with the SEC, including the most current annual report, 10-K and 10-Q, which contain a discussion of various factors that may affect CellPro's business. These factors could cause actual future performance to differ from current expectations. Particular attention should be given to the Investment Considerations labeled "Legal Proceedings," "Patents and Proprietary Technology" and "Dependence on CEPRATE(R) SC System," in CellPro's Annual Report on Form 10-K for the fiscal year ended March 31, 1997 and to the Company's press release dated July 29, 1997. Located in Bothell, Washington, CellPro, Incorporated is a biotechnology company that develops, manufactures and markets proprietary continuous-flow, cell-selection systems for use in a variety of therapeutic, diagnostic and research applications. Its CEPRATE(R) SC System is being marketed in the United States, Canada, the EC, Israel, Latin America and the Asia-Pacific area. CONTACT: CellPro Incorporated Mark Handfelt, 425/485-7644 e-mail: invest@cellpro.com http://www.cellpro.com http://www.businesswire.com/cnn/cpro.htm |
|
||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion