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RESEARCH PROGRAMS

Angiomates (STX 140)

Angiomates are multitargeted anticancer agents exhibiting both antiproliferative (which kill cancer cells) and antiangiogenic (which inhibit the network of blood vessels supporting the tumor) properties. These molecules could be used in treating hormone-dependent tumors and certain types of hematologic malignancy.

BIM 46187

BIM 46187 is an innovative anti-tumor compound that acts on cellular signals via the receptors attached to G-Protein (the most common form of receptors for neuropeptide hormones and neurotransmitters). BIM 46187 could be used either alone or in combination with other cancer therapies in the treatment of solid tumors, such as lung and prostate cancer, or in treating pain.

Inhibitors of the enzyme 17ß-hydroxysteroid dehydrogenase (1 and 3)

These molecules are enzyme inhibitors involved in the biosynthesis of steroid hormones. They will be targeted at treating hormone-dependent tumors (breast and prostate).

Cytotoxic peptide conjugates

These molecules are designed to target tumors which exhibit a specific receptor to a peptide hormone in order to selectively deliver an antiproliferative agent. The targeted tumors are neuroendocrine tumors which exhibit high levels of receptors for peptide hormones.

DEVELOPMENT PROGRAMS

Decapeptyl®

Ipsen is participating in two phase III studies, conducted under the auspices of the International Breast Cancer Study Group (IBCSG), for the adjuvant treatment of premenopausal breast cancer. These studies compare conventional treatment methods with hormone therapy combining Decapeptyl® with estrogen suppressor agents, such as Aromasin® marketed by Pfizer. They are scheduled to continue through to 2015. Their findings could lead to a revision of adjuvant treatment guidelines for breast cancer in premenopausal women expressing hormonal receptors. The Group has obtained an exclusive license covering expertise and new patent applications relating to the worldwide marketing rights for Decapeptyl® (excluding North America and certain other countries). Under the terms of the agreement, Ipsen has access to future sustained-release formulations of Decapeptyl® developed by Debiopharm.

Toremifene

The Group has acquired an exclusive European license to develop and market toremifene, a Selective Estrogen Receptor Modulator (SERM), from US biotech company GTx Inc. One of the two phase III studies of toremifene conducted by GTx in the US is now complete. It relates to the treatment of side-effects linked to anti-androgen hormone therapy in advanced prostate cancer. After submission of the supplemental New Drug Application (sNDA), the FDA requested a second phase III clinical study for this indication. This second phase III study will begin in 2010. In addition, a phase III study is in progress in connection with the prevention of prostate cancer among men with precancerous lesions (high grade intraepithelial neoplasia).

BN 83495

BN 83495 and the related molecules are selective inhibitors of the enzyme sulfatase involved in a key stage of the biosynthesis of estrogen, a major contributor to breast cancer among postmenopausal women. An initial phase I clinical trial among patients has been completed and the results demonstrate that the enzyme sulfatase is inhibited in tumor biopsies at the tested doses. A second phase I study has determined the optimal dose of BN 83495 in postmenopausal patients with advanced breast cancer expressing hormone receptors. During this second phase I trial, close to complete inhibition (95%) of the target enzyme in peripheral blood mononuclear cells was obtained at a dose of 40mg.

A pilot program in advanced prostate cancer is currently underway, together with a phase II study in advanced endometrial cancer.