Here's an example of what I'm talking about... sounds nice, but not to market yet:
Monday October 11, 8:32 am Eastern Time
Company Press Release
Nexell Researchers Identify Two Methods for Clinical Scale
Production of Cells That May Hold Key to Cancer Vaccines
Stem Cell Selection and Expansion Technologies Will Advance Study of Dendritic Cells That Prime
Immune System to Attack Tumor
IRVINE, Calif.--(BW HealthWire)--Oct. 11, 1999-- Researchers from Nexell Therapeutics Inc. (NASDAQ:NEXL - news), one of the
world's leading suppliers of therapeutic and diagnostic products based on stem cell technology, have developed clinical scale, closed
system processes using the Isolex® 300i Stem Cell Selection System and SteriCell® culturing bags to generate dendritic cells from either
monocytes or CD34+ cells. Results from two separate laboratory studies of the methods were presented at the 6th International
Workshop on Langerhans Cells in New York City on October 9.
''There is a great deal of excitement about the potential for using dendritic cells to focus patients' immune systems on attacking tumor
cells,'' said Michael T. Lotze, MD, Codirector of Biologic Therapeutics at the University of Pittsburgh Cancer Institute and a Plenary
Speaker at the Workshop. ''The work at Nexell demonstrates that the available selection and expansion technologies which they have
developed can be used to generate these key cells for clinical trials using two different methods. We are in the process of evaluating
these cells in early phase clinical trials designed to study the benefits of dendritic cell therapy.''
Dendritic cells act as the sentinels of the immune system by picking up foreign antigens and presenting them in the appropriate way to
T-cells, thereby triggering an immune response. Because they play this central role in controlling immunity, dendritic cells have become
the main focus of many experimental approaches to the treatment of cancer and infectious disease. For example, to stimulate the immune
system to attack cancer cells, several investigators are generating dendritic cells outside the body and then loading them with tumor
antigen, DNA for tumor antigen or enhancers of the immune system so the cells are able to present the tumor antigen efficiently to
immune system T-cells. The goal of these studies is to demonstrate that patients can be vaccinated effectively against their own cancer
through chronic stimulation of their immune response to the tumor through periodic infusion of dendritic cells which have been selectively
and specifically primed with tumor antigen.
Although there are several pathways for generating dendritic cells, it is thought that those derived from CD34+ cells are more effective in
presenting antigen. In one of the Nexell studies, mobilized apheresis products were enriched for CD34+ cells using the Isolex® 300i Cell
Selection System. These cells were then successfully cultured in SteriCell® closed system gas permeable containers to generate dendritic
cells. This study defines an efficient closed system process for generating dendritic cells from CD34+ cells.
In the second study, non-mobilized apheresis product was depleted of CD2+ and CD19+ cells with the Isolex® 300i to produce an
enriched population of CD14+ monocytes, the more common source for cultured dendritic cells. This process was completed in 2.5 hours
as compared to 8 to 10 using current methods of cell adherence at this scale. Dendritic cells were then successfully cultured in closed
SteriCell® containers. This second method also resulted in a dendritic cell preparation with fewer contaminating T-cells and a greater
ability to stimulate an in vitro immune response.
''We have been able to show that by culturing Isolex® enriched cells in SteriCell® containers we can efficiently generate high quality
dendritic cells in large quantities,'' said Dennis Van Epps, PhD, Vice President, Research, Nexell Therapeutics. ''By using these closed,
gas permeable containers, we have also minimized contamination risks associated with open culture systems.''
The Isolex® 300i Cell Selection System is a restricted device marketed in the United States for the selection of hematopoietic stem cells
and the removal of tumor cells from autologous peripheral blood as a component of aggressive cancer therapy (see system package insert
for more information). Isolex® cell selection systems are also marketed in the European Union and Canada and are available for use in
Hungary, Israel, New Zealand, Poland, and Slovenia. Nexell is seeking clearance to market the Isolex® systems in Australia, Japan and
various countries in Eastern Europe and the Mediterranean region. There are also a number of Isolex® systems currently in use in
investigational protocols (under IDEs) for gene therapy, dendritic cell therapy, organ tolerance induction, autoimmune disease, and
allogeneic (donor) transplants involving T-cell depletion.
Nexell Therapeutics Inc.
Located in Irvine, California, Nexell Therapeutics Inc. (NASDAQ:NEXL - news) is a cell therapy company whose mission is to put the
power of the cell into the hands of healers. Nexell is developing and marketing innovative ex vivo cell therapies and in vitro diagnostics for
cancer, autoimmune, metabolic and genetic diseases. Nexell's lead product is the Isolex® 300i Cell Selection System. In addition, Nexell
markets the Cytonex(TM) ImmunoCytoChemistry Staining Kit and an extensive line of cell therapy preparation, storage and expansion
products including the Cryocyte(TM), SteriCell® and Lifecell® brands.
The Private Securities Litigation Reform Act of 1995 provides a ''safe harbor'' for certain forward-looking statements. The
forward-looking statements contained in this release are subject to certain risks and uncertainties. Actual results could differ materially
from current expectations. Among the factors which could affect the Company's actual results and could cause results to differ from
those contained in the forward-looking statements contained herein are: the timely commencement and success of the Company's clinical
trials and other research endeavors, delays in receiving FDA or other regulatory approvals, the development of competing therapies
and/or technologies, the terms of any future strategic alliances, the possible need for additional capital, and any additional factors
described from time to time in the Company's periodic reports on Form 10-K and 10-Q, and any prospectus describing the Company's
securities.
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