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Positive Data Supporting A New Biomarker Predicting The Efficacy Of Current Hormone Therapies In Early Breast Cancers

Invivis , , a clinical stage biopharmaceutical private company focused on the development of oncology therapeutics, have announced new, positive data supporting the development of its biomarkers to be presented at the American Society of Clinical Oncology (ASCO) 2013 Annual Meeting, May 31-June 4, 2013 in Chicago, Illinois.

Antiestrogen treatments are key components in treatment strategies. Although two-third of diagnosed express the estrogen receptor, the target of estrogen inhibitors, this treatment is probably effective in about 50% of the cases and less in case of relapse. Invivis is developing a family of biomarkers to support drugs developments. The company has identified in tumor tissues a biomarker which indicate that the estrogen receptor is in an active conformation and thus targetable. On the other hand, the expression of ER without the biomarker would predict treatment inactivity. The company has tested this hypothesis in a retrospective cohort of patients.

“We are very pleased with the findings as they support the development of our diagnostic test for antiestrogens to help identify patients with activated estrogen receptors in breast cancers who are most likely to benefit from treatment,” said Erard Gilles, Chief Executive Officer and President, Invivis Pharmaceuticals.

The findings will be presented during the following poster presentations:

Clinical and Pathological Correlation of the Activated Form of the Estrogen Receptor (ER) in Breast Cancer (BC) Abstract #117668; Poster #7H

Poster session : Saturday, June 1; 1:15 – 5:00 p.m. CT; S Hall A2

The study examined the treatment outcome correlations of a biomarker analyzed in 303 archival breast cancer samples processed with ER alpha specific antibodies. All but 3 ER positive cases had received anti-estrogens. ER status was D-ER in 78% of the biopsies and 22% A-ER of the biopsies. PD was associated with D-ER pattern (p=0.06). A-ER was assoiated with higher grade tumors. For ER Positive tumor, the A-ER was numerically better than D-ER (HR = 0.3, p=0.24 two-sided). This study supports the hypothesis that anti-estrogens are mainly active in breast cancer with the A-ER pattern.

“This data is a first, yet decisive step in the validation process of our biomarkers. This biomarker is in a unique position, as it can be tested retrospectively. It would have a short term impact as hormone therapies are available by helping to make better therapeutics choices. We are committed to develop a series of biomarkers as companion diagnostics for new drugs. One example is the activated progesterone receptor and onapristone, which is developed by Arno Therapeutics and with whom we actively collaborating. These two biomarkers are very similar.”

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About Breast Cancer

In the United States, over 232,300 new cases of invasive breast cancer are expected to be diagnosed in women and over 2,200 new cases are expected in men during 2013. After cancers of the skin, breast cancer is the most frequently diagnosed cancer in women. More than 40,000 breast cancer deaths are expected in 2013, with the majority in women.

Invivis Pharmaceuticals