Arno Therapeutics Submits IMPD to French Health Authority to Initiate Phase I Trial of Onapristone
Arno Therapeutics Submits IMPD to French Health Authority to Initiate Phase I Trial of Onapristone in PR Positive Tumors
Trial to Determine Recommended Dose for Phase II Study
FLEMINGTON, N.J., Sept. 9, 2013 (GLOBE NEWSWIRE) -- Arno Therapeutics, Inc. (OTCQB:ARNI), a clinical stage biopharmaceutical company focused on the development of oncology therapeutics, today announced it has submitted an Investigational Medicinal Product Dossier (IMPD) to the French Health Authority, L'Agence Nationale de Securite du Medicament et des Produits de Sante (ANSM), to request the clinical trial authorization of a Phase I dose escalation study evaluating Arno's lead compound onapristone in progesterone receptor positive tumors 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 tumors. 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.
About Arno Therapeutics
Arno Therapeutics is a clinical stage biopharmaceutical company developing innovative products for the treatment of cancer. Arno has exclusive worldwide rights to develop and market three innovative anti-cancer product candidates. These compounds are in clinical or preclinical development as product candidates to treat hematologic malignancies and solid tumors. For more information about the company, please visit www.arnothera.com.
This press release contains forward-looking statements that involve substantial risks and uncertainties. These statements are often, but not always, made through the use of words or phrases such as "anticipates," "expects," "plans," "believes," "intends," and similar words or phrases. These forward-looking statements include, without limitation, statements regarding the timing, progress and anticipated results of the clinical development of onapristone, including the timing of the initiation of the planned Phase I clinical trial of onapristone, Arno's belief concerning the adequacy of the IMPD submitted to the ANSM, the function of APR as a biomarker of anti-progestin activity, the mechanism of action of onapristone, the timing and status of Arno's efforts to develop a diagnostic test for use with onapristone, as well as Arno's strategy, future operations, outlook, milestones, future financial position, future financial results, plans and objectives. We may not actually achieve these plans, intentions or expectations and Arno cautions investors not to place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make.
Various important factors could cause actual results or events to differ materially from the forward-looking statements that we make.
Such factors include, among others, risks that the results of clinical trials will not support our claims or beliefs concerning the effectiveness of onapristone or any of our other product candidates, our ability to finance the development of our product candidates, regulatory risks, and our reliance on third party researchers and other collaborators. Additional risks are described in the company's Annual Report on Form 10-K for the year ended December 31, 2012, and its Quarterly Report on Form 10-1 for the quarter ended June 30, 2013. Arno is providing this information as of the date of this press release and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.
CONTACT: The Ruth Group
Stephanie Carrington (investors)
Kirsten Thomas (media)
Posted: September 2013