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Wednesday November 8, 6:45 am Eastern Time
Press Release
Targeted Genetics Corporation Announces Intent to Spin-Off Cell Therapy Technology
CellExSys to Focus on Antigen-Specific Cell Therapy and Research Applications of Rapid Expansion Method (REM) Technology
SEATTLE--(BW HealthWire)--Nov. 8, 2000-- Targeted Genetics Corporation (Nasdaq:TGEN - news) today announced that it intends to spin out the Company's portfolio of cell therapy-related assets and intellectual property into a newly created, wholly owned subsidiary company called CellExSys. As a wholly owned subsidiary focused on patient specific cell therapy and other applications of the REM technology, CellExSys will be well-positioned to identify and take advantage of appropriate product, partnership and financing opportunities that fall outside the field of in vivo gene delivery. CellExSys intends to seek funding outside of Targeted Genetics for its research and development efforts in 2001. The announcement was made in conjunction with the Company's presentation later today at the Techvest LLC Second Annual Conference on Tissue Repair, Replacement and Regeneration in New York City.
``The spin-out of our cell therapy portfolio is a strategic initiative designed to maximize the value of the assets that Targeted Genetics has in the area of T-cell technology,'' said H. Stewart Parker, President and Chief Executive Officer of Targeted Genetics. ``As Targeted Genetics further focuses on developing its leadership position in in vivo gene delivery, we believe that our significant body of cell therapy related patents and technology will be leveraged most efficiently in an environment focused on ex vivo therapies. With its robust intellectual property portfolio, CellExSys will be positioned to attract significant partners and investors focused on ex vivo cell therapy. Targeted Genetics intends to maintain a significant equity position in CellExSys and will be the exclusive manufacturer for any gene delivery vectors that CellExSys may utilize as it develops T-cells as gene delivery vehicles. This arrangement will enable our shareholders to benefit from the success of the spin-out.''
Targeted Genetics has 79 issued patents and patent applications in the area of cell therapy and other applications of T-cell technology. The Company has exclusive rights to a patent, issued to the Fred Hutchinson Cancer Research Center in October 1998, related to a process for rapidly expanding cytotoxic T-lymphocytes in culture to millions or billions of cells that retain their ability to recognize specific disease-related antigens. This rapid expansion method (REM) enables key effector cells of the immune system to be expanded in a timely and cost-effective manner, and is designed to overcome the hurdles previously associated with ex vivo cell therapy -- the inability to culture sufficient numbers of antigen-specific cells. The portfolio of intellectual property includes patents and patent applications relating to modification of T-cells with chimeric receptors, the use of T-cells as gene delivery vehicles and other proprietary technologies related to cellular therapy.
``The immune system has the capacity to eliminate malignant as well as virally infected cells,'' said Dr. Philip Greenberg, Member of the Fred Hutchinson Cancer Research Center and Professor of Medicine and Immunology at the University of Washington. ``In certain disease settings, however, the replication of diseased cells either interferes with the generation of an effective response or outpaces the body's ability to make sufficient quantities of the appropriate immune cells, in particular T-cells. The goal of T-cell therapy is to amplify the number of the relevant immune cells in the body in order to enhance the body's natural ability to recognize and fight disease. Some of the early attempts to achieve this goal failed because they did not identify and selectively amplify antigen-specific T-cells as the critical class of immune cells. The REM technology can be used to identify the few T-cells that are capable of recognizing diseased cells and to expand these cells to numbers that potentially allow the body to fight disease effectively.''
``We believe there is enormous potential in this technology in the area of cell therapy as well as in antigen discovery, functional genomics and drug development initiatives,'' continued Ms. Parker. ``Antigen-specific cytotoxic T-lymphocytes are the effector cells that recognize disease-related antigens and eliminate diseased cells from the body. Rather than trying to stimulate a T-cell response indirectly through the use of dendritic cells, or utilizing polyclonal T-cells, which are non-specific, the REM technology provides a process by which the appropriate effector cells can be manufactured quickly and in a cost-effective manner. We believe that the REM technology is the approach with the greatest potential of making cellular therapy a reality and unlocking the full potential of T-lymphocytes as important research tools for the development of other therapeutics. The ability of T-cells to recognize and respond to defined antigens may have particular utility in antigen identification and the development of therapeutic proteins and small-molecule drugs. In establishing CellExSys, we will be in an excellent position to attract the intellectual and financial resources needed to commercialize these important assets.''
Rapid Expansion Method (REM)/Targeted CTL Generation Background
The Rapid Expansion Method (REM) is a proprietary technology, developed by Targeted Genetics and researchers at The Fred Hutchinson Cancer Research Center, for the expansion of human antigen-specific T-cells 1000 fold in a two week time period. Competing commercial or research technologies for rapid expansion of T-cells are capable of expanding only undefined T-cell populations whose function is unknown. Targeted Genetics' technology is different in that it provides: 1) expansion of defined antigen-specific T-cell clones or bulk populations that recognize specific disease-related antigens; 2) retention of specific function and phenotype of the expanded T-cells; and 3) rates of expansion that are 50-100 fold greater than the competing technologies. These features give researchers at CellExSys the potential to exploit the power of the body's natural defense mechanisms to develop treatments for infectious diseases and cancer in a process known as adoptive immunotherapy.
Adoptive Immunotherapy Background
The human body is bombarded daily with infectious agents and potentially cancer-causing DNA damage. Normally, these assaults do not lead to chronic diseases such as cancer or hepatitis but usually cause an acute, self-limited disease that is resolved within a matter of days. The cellular immune system is responsible for keeping these assaults in check. The cellular immune system is comprised of two subsets of T-cells: CD4+ helper T-cells and CD8+ cytotoxic T-cells (CTLs). These T-cell subsets act in concert to eliminate virally infected or malignantly transformed cells. Activation and expansion of CTLs requires a complex set of cellular interactions including cytokines and other factors produced by antigen-specific CD4+ helper T-cells. Chronic viral infection or cancer occurs when these assaults overwhelm the ability of CTLs to eliminate diseased cells. Adoptive immunotherapy is a process in which researchers remove a small amount of blood from the patient and isolate the very small number of CTLs specific for the disease present in the patient. Once isolated, these cells are expanded to numbers (billions) necessary to combat the overwhelming disease burden in the patient. These targeted CTLs are then infused into the patient to cure or contain the disease. Animal models of current expansion technologies result in only a seven to 10 fold increase in cell number in a seven to 10 day period and require reagents not available for human use. The REM technology overcomes these hurdles for treating human disease, allowing billions of cells to be produced in less than two weeks.
The majority of therapies on the market or under development for chronic viral and malignant disease act to stimulate a targeted CTL response (e.g. therapeutic vaccines) or manage disease burden (e.g. protease inhibitors) in an effort to stimulate in vivo expansion of the patients' own targeted CTLs. CellExSys is the only company developing direct approaches to harness the power of the immune system via the REM technology. Application of the REM technology to adoptive immunotherapy may enable the potential of this approach to be realized.
Targeted Genetics Corporation develops gene therapy products for the treatment of acquired and inherited diseases. The Company has lead clinical product development programs targeting cystic fibrosis and cancer, and a promising preclinical pipeline of product candidates focused on hemophilia A, arthritis, cancer, cardiovascular disease and AIDS prophylaxis. The Company has a broad platform of gene delivery technologies, as well as a promising body of technology for cellular therapy. For more information about Targeted Genetics Corporation please visit the Company's web site at targetedgenetics.com.
This release contains forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from those projected. The words ``believes,'' ``expects,'' ``intends,'' ``anticipates,'' and similar expressions identify forward-looking statements, but their absence does not mean that the statement is not forward-looking. These statements are not guarantees of future performance. A number of factors could affect the Company's actual results including the risk factors described in the Company's latest Quarterly Report on Form 10-Q filed with the SEC. You should not place an undue reliance on these forward-looking statements, which speak only as of the date of this release. The Company undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date of this release.
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Contact:
Targeted Genetics Corporation
Stephanie Seiler, Ph.D., 206/521-7823 |
