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Ipsogen Announces Three Studies at the American Society of Clinical Oncology (ASCO) Meeting Extending the Utility of the Genomic Grade Index for Predicting Response to Chemotherapy in Breast Cancer
Date:5/19/2008

MARSEILLE, France, May 19 /PRNewswire/ -- IPSOGEN SA (Marseille and New Haven), a cancer profiler that develops and markets molecular diagnostic assays for blood & breast cancers, announced today that researchers from the University of Texas MD Anderson Cancer Center (MDACC, Houston, TX) will present the results of two studies on the Genomic Grade index (GGi) at the ASCO Annual Meeting, held in Chicago from May 30 to June 3, 2008. The data indicate that the Genomic Grade index predicts response to chemotherapy in breast cancer. A third study extends the pronostic utility of the GGi to inflammatory breast cancer.

The Genomic Grade index (GGi) is a 97-gene measure of tumor grade, a key prognostic indicator of breast cancer agressiveness closely related to cellular proliferation. Ipsogen is the exclusive worldwide licensee of the GGi technologies.

Two MD Anderson Cancer Center studies

In a preliminary study published in May 2008 in Breast Cancer Research (1) conducted on 133 patients, MDACC researchers had found that, among 852 genomic indexes describing biological pathways, the GGi was one of the most promising candidate for predicting response to chemotherapy.

In the first study to be presented (abstract 541, (2)), Dr. Symmans and colleagues from MDACC and Institut Bordet (Brussels, Belgium) validated the GGi as a predictive marker of chemotherapy response in 229 patients with HER2-normal breast cancer. All patients were treated with a current standard chemotherapy regimen, T/FAC (6 months of paclitaxel followed by 5-fluoruracil, doxorubicin, and cyclophosphamide) then by surgery. In such preoperative chemotherapy settings, treatment efficacy can be rapidly & precisely assessed by examining the resected tumor in a pathology laboratory.

This study concludes that high GGi is predictive for increased sensitivity to T/FAC chemotherapy in both ER- and ER+ patients. In addition, the GGi can be combined with ER and nodal status to predict which patients will not respond to preoperative T/FAC chemotherapy in 72 % of cases.

"This work demonstrates that high genomic grade, as a robust measure of proliferation in the tumor cells, is associated with benefit from chemotherapy. In the context of other published work it underlines the association between high tumoral proliferation rate and chemosensitivity, endocrine insensitivity and worse prognosis" comments Dr. Symmans, associate Professor of Pathology at the MDACC.

"This study is a straightforward demonstration of the clinical utility of the Genomic Grade index for predicting response to chemotherapy. It also highlights the ongoing commitment of the oncology community to validate new molecular assays that strongly connect with the breast tumor biology and fit within the pathologist's practices" comments Dr. Jean-Marc Le Doussal, Director of Breast Cancer Program at Ipsogen.

Visit Ipsogen booth 23128 at the 44th ASCO annual meeting

In the second study to be presented (abstract 527, (3)), Dr. Pusztai and colleagues showed a pionnering application of multi-testing on genome-wide microarrays by combining the GGi, for the prediction of chemotherapy response, with the 200-gene endocrine-sensitivity index, for the prediction of hormonotherapy response.

"This study further confirms the potential of Ipsogen's pipeline strategy of multiple high-resolution genomic measurements to improve the decision tree of chemotherapeutic options in breast cancer>> says Vincent Fert, CEO of Ipsogen. "We are fully committed to rapidly translate these clinical findings into regulatory-approved and reimbursed test offering to European and American patients," he adds.

One University of Antwerp study

A third study (abstract 11048, (4)), presented by Dr. Van Laere from Antwerp University, Belgium, validates the pronostic value of the GGi in inflammatory breast cancer, an aggressive type of breast cancer affecting a few percent of patients.

About IPSOGEN

Ipsogen is a cancer profiler that develops and markets molecular diagnostic assays designed to map diseases and guide patients and clinicians decisions along the complex therapeutic path.

With more than 60 tests already used routinely worldwide for the diagnosis, prognosis and follow-up of thousands of patients with leukemia, Ipsogen is now also targeting breast cancer. Its initial goal will be to provide diagnostic information that has been inaccessible until now. Ipsogen is also a partner of choice for biopharmaceutical companies committed to revolutionary theranostics.

Strengthened by its first-rate scientific, clinical and technological partnerships, in addition to its highly-skilled multidisciplinary team in France and the US, Ipsogen is striving to become the leader in the molecular profiling of cancers. It is pursuing its development and promotion of diagnostic standards that have a significant impact on patients, medical professionnals and society in general.

Ipsogen employed 40 people as of April 30,2008. Its headquarters are located in Marseille, France. The company also has a subsidiary, Ipsogen Inc., in New Haven, Connecticut, USA.

Find out more at http://www.ipsogen.com

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(1) Tordai A, Wang J, Andre F, Liedtke C, Yan K, Sotiriou C, Hortobagyi GN, Symmans FW, Pusztai L. Evaluation of biological pathways involved in chemotherapy response in breast cancer. Breast Cancer Research 2008, 10:R37.

(2) W. F. Symmans, C. Hatzis, C. Liedtke, C. Desmedt, V. Valero, H. M. Kuerer, G. N. Hortobagyi, M. Piccart-Gebhart, L. Pusztai, C. Sotiriou. Use of genomic grade index (GGI) to predict pathologic response to preoperative chemotherapy in breast cancer. J Clin Oncol 26: 2008 (May 20 suppl; abstr 541).

http://www.abstract.asco.org/AbstView_55_32175.html

(3) L. Pusztai, C. Hatzis, F. Cardoso, C. Sotiriou, V. Lazar, M. Piccart-Gebhart, G. N. Hortobagyi, L. van't Veer, W. F. Symmans. Combined use of genomic prognostic and treatment response predictors in breast cancer. J Clin Oncol 26: 2008 (May 20 suppl; abstr 527).

http://www.abstract.asco.org/AbstView_55_33741.html

(4) S. J. Van Laere, G. G. Van den Eynden, I. Van der Auwera, X. B. Trinh, P. A. van Dam, E. A. Van Marck, P. B. Vermeulen, L. Y. Dirix. Inflammatory breast carcinoma signature and relapse-free survival in patients with noninflammatory breast cancer. J Clin Oncol 26: 2008 (May 20 suppl; abstr 11048).

http://www.abstract.asco.org/AbstView_55_34698.html


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