Arno Therapeutics, Inc., a clinical stage biopharmaceutical company focused on the development of oncology therapeutics, has submitted an Investigational Medicinal Product Dossier (IMPD) to the French Health Authority, L'Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), to request the clinical trial authorization of a phase I dose escalation study evaluating Arno's lead compound onapristone in progesterone receptor positive tumours in post-menopausal women. Arno expects to initiate the phase I trial in the fourth quarter of this year.
The submission follows the initiation of a pharmacokinetic (PK) study of onapristone in France last month. The PK study will determine the metabolism of the drug and the effect of food on drug absorption in healthy volunteers.
Onapristone is an anti-progestin hormone blocker that has been shown to have considerable anti-tumor activity in breast cancer. Onapristone appears to have a unique ability to block the activated progesterone receptor (APR), which is believed to be the mechanism that may inhibit the growth of breast, endometrial and other tumours. The APR has the potential to function as a biomarker of anti-progestin activity.
The goal of the phase I study will be to define the recommended phase II dose and determine the overall safety profile.
"On the heels of initiating the PK study of onapristone, the filing of an IMPD for a phase I trial represents a second critical step in our lead compound's clinical development program," said Alexander Zukiwski, MD, chief medical officer of Arno Therapeutics. "We believe the submitted package for onapristone meets the requirements necessary to begin phase I trials in France later this year. Initiating the next phase in the development of this compound, along with developing a diagnostic test for a biomarker, is an important milestone for the Company as we continue to focus on bringing a targeted and personalized treatment to patients with an unmet medical need."
Arno has selected Biotrial, a drug evaluation and pharmacology research company that is currently conducting the PK study, as its contract research organization for the phase I trial.
Arno Therapeutics is developing innovative products for the treatment of cancer.