|Creating the next generation of cancer treatments
January 7, 2014
Arno Therapeutics Selects Leica Biosystems to Develop Companion Diagnostic for Targeted Oncology Therapy Onapristone
FLEMINGTON, N.J. and NEWCASTLE UPON TYNE, England - January 7, 2014 - Arno Therapeutics, Inc. (OTCQB: ARNI); (Arno), a clinical stage biopharmaceutical company focused on the development of oncology therapeutics, and Leica Biosystems (LBS), a global leader in pathology workflow solutions and automation , announced that the companies have entered into a co-development agreement for the development of a companion diagnostic (CDx) for Arno's lead compound and personalized therapy, onapristone.
Onapristone is an oral, anti-progestin hormone blocker that has been shown to have anti-tumor activity in breast cancer. Onapristone appears to selectively block the activation of the progesterone receptor (APR). This is believed to inhibit the growth of APR-driven breast, endometrial and other tumors.
The CDx will be an immunohistochemical (IHC) in vitro diagnostic (IVD) test used to detect APR in various women's cancers, including endometrioid and breast cancer. This CDx test will help to identify patients who are APR positive and therefore most likely to respond to treatment with onapristone. This also has potential application in castration-resistant prostate cancer (CRPC). In preclinical work sponsored by Arno, IHC testing on archived specimens has shown that approximately 40% of archived endometrioid cancer specimens and approximately 25% of archived breast cancer specimens were APR positive. Initial findings by Arno indicate that progesterone receptor (PR) was present in CRPC specimens and potentially active in a subset of tumors. Further investigation is underway to determine the frequency of APR positive tumors in CRPC specimens.
Under the terms of the co-development agreement, Arno will sponsor and conduct clinical trials for onapristone. Leica will develop and validate the CDx for APR with responsibility for ensuring the investigational CDx kit is ready, available and meets FDA and other health authority standards for a planned Phase II trial of onapristone in endometrioid cancer. The co-development program aims to achieve simultaneous approval and launch of onapristone and the CDx IVD for APR.
"This agreement with Leica Biosystems is a significant milestone for Arno and an important step forward in the development of onapristone. We believe that partnering with a world-class organization such as Leica will enable us to quickly and effectively get to reliable, reproducible and practical APR positive tumor detection. This will help identify the patients most likely to benefit from treatment with onapristone," said Glenn Mattes, Chief Executive Officer of Arno Therapeutics. "We are excited about what the future holds for Arno as we enter a critical period for the Company with the commencement of our first Phase I trial which will evaluate onapristone in progesterone receptor positive tumors."
"We are pleased to partner with Arno to co-develop this companion diagnostic for onapristone," added Dr. Matthias Weber, President of Leica Biosystems. "Personalized medicine is a key development in oncology. We believe that diagnostics such as the APR test will play a critical role in the broader effort to improve quality of care for patients."
About Leica Biosystems
Leica Biosystems is a global leader in pathology workflow solutions and automation, striving to advance cancer diagnostics to improve lives. Leica Biosystems provides anatomical pathology laboratories and researchers a comprehensive product range for each step in the pathology process, from sample preparation and staining to imaging and reporting. Leica's easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence. Further information can be found at www.LeicaBiosystems.com.
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.
Forward-Looking Statements: 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, the ability of the CDx under development with Leica Biosystems to help identify patients who are APR positive and Arno's use of the CDx in its clinical development program of 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 the CDx to be developed for use with onapristone, 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. 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.
The Ruth Group
Lee Roth (investors)
Kirsten Thomas (media)
Arno Therapeutics, Inc.