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Xcyte Therapies And Fresenius Biotech GmbH Enter HIV Gene Therapy Collaboration

10/19/2005 5:09:42 PM

SEATTLE--(BUSINESS WIRE)--Jan. 15, 2004--Xcyte Therapies, Inc. today announced that it will collaborate with Fresenius Biotech GmbH, a division of Fresenius AG (Frankfurt Stock Exchange: FRE, SRE 3), in a T cell-based gene therapy program for treating HIV infection. The program is focused on restoring HIV-infected patients' immune systems by administering gene-modified T cells that are rendered resistant to HIV infection.

The agreement grants Fresenius an exclusive license to the Xcellerate(TM) Technology in Europe for treating HIV/AIDS with gene-modified T cells. The agreement provides Xcyte Therapies with milestone payments as well as royalty payments on product sales.

Under the collaboration announced today, Xcyte Therapies will transfer to Fresenius its proprietary Xcellerate(TM) Technology, which has been designed for the activation, expansion and manufacture of human T cells outside the body, which we call Xcellerated T Cells(TM).

Fresenius and its partners have developed a gene-based therapeutic approach in which T cells are made resistant to HIV infection by preventing the virus from entering these cells. In this approach, a portion of a patient's T cells is removed, and the anti-HIV gene is permanently introduced into T cells using a retroviral gene delivery system. These "transduced" T cells are infused into the infected individual. Although some of the remaining T cells in the individual may be infected with the virus and eventually die, it is anticipated that the gene-modified cells would have a survival advantage, and increase in number over time. If the numbers of these cells increase sufficiently, CD4+ helper T cell function may return to normal, providing treated patients with healthy immune systems. Laboratory studies by Fresenius' scientists and its partners provided the rationale to bring this approach to the clinic. Fresenius has indicated that they plan to commence clinical trials in 2004.

T cells are immune cells that play a central role in fighting cancer and infection. In HIV infection, CD4+ T cells, or helper T cells, are a major target for infection. CD4+ T cells not only have the ability to mount a direct offense against cancerous or infected cells, but also help orchestrate the activity of other cells of the immune system. A hallmark of HIV infection is the progressive loss of CD4+ T cells. Loss of these cells leads to profound immunodeficiency rendering individuals susceptible to life-threatening infections. Current drugs, when used in combination, have been shown to be effective at blocking disease progression. However, administration of these drugs requires complicated dosing schedules and is associated with a number of toxicities. Furthermore, there are increasing numbers of HIV-infected individuals who are failing these therapies. Thus, the development of new treatment strategies is critical for the effective treatment of this disease.

"Fresenius is developing a new gene therapy approach in which genes are inserted into T cells to make them resistant to infection," said Thomas Gottwald, MD, PhD, President of Fresenius Biotech. "Therefore, we have partnered with Xcyte, one of the leading companies developing cellular immunotherapy products. With their focus on T cell therapy, we believe that Xcyte represents the ideal partner for us to work with to produce our genetically-modified T cells, which represent a new potential therapy for HIV."

"We are excited about this opportunity to work with Fresenius in an effort to bring novel therapies for treating HIV infection to the clinic," said Ronald J. Berenson, M.D., President and Chief Executive Officer of Xcyte Therapies. "We believe that the Xcellerate Technology is an enabling technology for T cell-based gene therapy." Fresenius and their collaborators have developed a new approach using gene therapy that may provide for an effective, non-toxic, long-lasting treatment for HIV-infected individuals. With the increasing number of individuals that are failing current therapies (HAART) and the lack of an HIV vaccine, there is a need for new therapeutic strategies that are not sensitive to the standard viral escape mechanisms employed by the HIV virus. We believe the gene therapy approach being developed through this partnership may meet this need."

Fresenius Biotech GmbH is a company within the Fresenius Group, with the goal of developing and marketing biopharmaceuticals in the fields of oncology, immunology and regenerative medicine. Fresenius is an internationally operating health care group with products and services for dialysis, the hospital and the ambulatory medical care of patients.

Xcyte Therapies is a privately held Seattle-based biotechnology company. The Company is developing a new class of therapeutic products that enhance the body's natural immune responses to treat cancer, infectious diseases and other medical conditions associated with weakened immune systems. Xcyte Therapies recently completed Phase I and Phase I/II clinical trials in advanced kidney cancer and prostate cancer, respectively. The Company is currently conducting Phase I/II clinical trials in multiple myeloma and chronic lymphocytic leukemia. Xcyte(TM), Xcyte Therapies(TM), Xcellerate(TM), Xcellerated T Cells(TM) and the circle logo are registered trademarks of Xcyte Therapies, Inc.

NOTE: This release contains forward-looking statements regarding the performance of our potential products and the development of future potential products, which are based on the opinions and estimates of our management at the time the statements are made and are subject to risks and uncertainties that could cause actual results to differ materially from those expected or implied by the forward-looking statements. Inaccurate assumptions and known or unknown risks and uncertainties can affect the accuracy of these forward-looking statements. Factors that could affect our actual results include, but are not limited to, the timing and nature of the results of our clinical trials and the success of our research and development programs. You should not unduly rely on these forward-looking statements, which speak only as of the date of this release. We undertake no obligation to update any forward-looking statements to reflect new information, circumstances or events after the date of this release or to reflect the occurrence of unanticipated events.

Contact: Xcyte Therapies, Inc. Ronald J. Berenson, MD, 206-262-6200

Source: Xcyte Therapies, Inc.

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