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Cytheris Releases Promising Clinical Data on
its Interleukin-7 Immune Enhancer at the 2007 CROI Meeting in Los
Angeles
Paris, March 5, 2007 - Cytheris, a product-oriented
biopharmaceutical company focused on the research and development of new and
critical agents for immune modulation, announced today promising results from
two phase I clinical studies of Cytheris Interleukin-7. The announcement follows
presentation of the results by the AIDS Clinical Trial Group (ACTG) and French
clinical investigators at the Conference on Retroviruses and Opportunistic
Infections held February 25-28th in Los Angeles.
The studies both showed extremely good tolerance and an impressive increase in
the patient's CD4 T cells, the count of which is frequently used by HIV patients
to gauge their own health. This is the first product to demonstrate such an
impressive increase of CD4 T cells and CD8 T cells together with a good clinical
tolerance.
At the Los Angeles meeting, the ACTG communicated the results of an IL-7 phase I
single dose study performed in US and a team of leading French clinical
investigators communicated on a phase I/II repeated dose study performed in
Paris, France.
Both studies performed in HIV infected patients were designed to assess product
safety and activity by measuring cellular immune recovery. HIV infected
patients' main immune deficit shows up in a severe loss of CD4 T cells, the
pivotal cells in charge of orchestrating immune responses. Interleukin-7 is a
recombinant human protein whose critical role for T cell maintenance and
recovery is broadly documented in pre-clinical models.
In both studies and more specifically in the repeated dose study, Cytheris IL-7
treatment was extremely well tolerated and led to an impressive and prolonged
increase of patient's CD4 T cells. This increase was systematically observed in
all patients. It involved CD4 and CD8 T cells and both naïve and memory T cells.
This broad spectrum of immune activities suggests a very promising outlook in
terms of reaching clinical significance and preventing opportunistic diseases or
secondary fatal malignancies.
"In addition, new results from large clinical studies presented at this CROI
meeting are extremely positive for Cytheris, and give us confidence as we line
up further clinical trials in France, Canada and the US" said Michel Morre,
Cytheris CEO. "This new data now demonstrates how critical patients' CD4 numbers
are in protecting them not only from opportunistic infections but also from
AIDS-related or non-related diseases.
"So we are highly encouraged by the fact that our most recent IL-7 results
demonstrate the impressive ability of this product to restore protective CD4 T
cell counts. The rapidly growing amount of research data showing the link
between HIV patients' CD4 counts and their long term outcome will also provide a
favorable environment for the clinical development of IL-7 which is looking like
a key product for CD4 cell recovery. These IL-7 effects are very consistent with
the results already obtained in two other studies in the field of oncology."
About Cytheris:
Cytheris, Paris, is a product-oriented biopharmaceutical company focused on
the research and development of new and critical agents for immune modulation.
These drugs aim at reconstituting, enhancing or modulating the immune system
activity of patients suffering from life-threatening diseases. The company's
lead compound is a recombinant Interleukin-7 (rIL-7) a critical growth factor
for immune T Cells. It has a second family of products based on NKT ligands
in-licensed from New York University, the Aaron Diamond AIDS Research Center and
the City University of New York. Cytheris has a strong network of collaborations
with world-leading academic and clinical teams as well as pharmaceutical
companies. The company was founded in 1999 and today employs around 20
experienced people in Europe and in the USA. The company, based in Issy les
Moulineaux, Paris, has a subsidiary in Rockville (MD-USA). Website:
www.cytheris.com
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For further information, please contact:
Andrew Lloyd & Associates
Andrew Lloyd / Neil Hunter
Tel: +44 1273 675100
allo@ala.com
/ neil@ala.com
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