Ipsen Initiates An Advanced Endometrial Cancer Program With BN83495, Its First-in-Class Steroid Sulfatase Inhibitor First Patient Dosed In Phase II

Main Category: Cancer / Oncology
Also Included In: Women's Health / Gynecology
Article Date: 25 Nov 2009 - 19:00 PST

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Ipsen (Paris:IPN) announced the initiation of an international, multi-center, controlled, randomized Phase II clinical trial to evaluate the safety and efficacy of BN83495, its investigational first-in-class steroid sulfatase (STS) inhibitor, in advanced endometrial cancer. BN83495 is currently being studied in several clinical studies in patients with hormone dependent cancers.

Stéphane Thiroloix, Executive Vice-President, Corporate Development said :"We are very pleased to be moving BN83495 into phase II in this indication. This first-in-class steroid sulfatase inhibitor can potentially significantly improve lives of patients with advanced endometrial cancer. With further indications in breast, prostate and ovarian cancers, we believe Ipsen with its focus on hormone dependent cancers will fully leverage the value of BN83495."

About BN83495

Ipsen's lead oncology development candidate, BN83495, is a first-in-class orally available irreversible steroid sulfatase (STS) inhibitor. The steroid sulfatase pathway gives rise to oestrone and dehydroepiandrosterone (DHEA) that in turn produce oestradiol and androstenediol (Adiol) that can both stimulate the growth of hormone-dependent tumours. The compound is currently in further clinical development for postmenopausal metastatic breast cancer as well as in PI/II clinical development for castrate resistant prostate cancer. Ipsen plans to expand the clinical program to include ovarian cancers in the near future.

About the trial

The clinical trial will compare single-agent BN83495 to megestrol acetate (MA) in post-menopausal women with histologically confirmed hormone receptor positive endometrial cancer, presenting with recurrent or advanced disease not eligible for treatment with surgery and radiotherapy.

The primary endpoint for the study is progression-free survival. Overall survival and response rate will be evaluated as secondary endpoints. This is the first Phase II clinical trial to begin this year examining the safety and efficacy of BN83495 in patients with different solid tumors.

About Endometrial Cancer

Endometrial cancer, which develops from the inner lining of the uterus, is the most common cancer found in the female reproductive system.

According to the American Cancer Society, about 40,100 new cases of endometrial cancer were diagnosed in the United States and approximately 7,470 women died from this disease in 2008.

Source
Ipsen