|Creating the next generation of cancer treatments
May 14, 2014
Arno Therapeutics to Outline Two Phase I Studies Evaluating Onapristone in Men's and Women's Cancers at 2014 ASCO Annual Meeting
- Studies to determine recommended Phase II dose and safety profile of lead compound -
- Will analyze relationship of biomarker to any anti-tumor activity observed -
FLEMINGTON, NJ - May 14, 2014 - Arno Therapeutics, Inc. (OTCQB: ARNI), a clinical stage biopharmaceutical company focused on the development of oncology therapeutics, today announced two, separate abstracts outlining the study designs of ongoing Phase I clinical trials evaluating its investigational lead compound onapristone to be presented at the upcoming 50th American Society of Clinical Oncology (ASCO) Annual Meeting, being held May 30 – June 3, 2014 in Chicago, Illinois.
Arno will present the objectives, methods and study designs for its two ongoing studies, a Phase I trial in women with progesterone receptor (PR) expressing tumors and a Phase I/II trial in men with advanced castration-resistant prostate cancer (CRPC), who have failed treatment with abiraterone or enzalutamide. Each study is two-stage with an expansion component; the first stage evaluates dose selection and the second expands the number of patients at the determined recommended Phase II dose to confirm the safety profile and provide a preliminary assessment of anti-tumor activity.
"The strategically-planned study designs of both trials enable us to advance the clinical evaluation of targeted therapy onapristone with the goal of determining the recommended Phase II dose and safety profile in the most efficient and effective means possible," said Glenn Mattes, President and Chief Executive Officer of Arno Therapeutics. "Perhaps even more importantly, we intend to analyze the relationship of the biomarker, that being the activated form of the progesterone receptor, to any anti-tumor activity that is observed. Earlier this year, we began actively enrolling patients in both trials and also began the development of a companion diagnostic for the selection of patients more likely to benefit from treatment with onapristone. We are encouraged by the significant potential of onapristone to be a first-in-class anti-progestin compound for oncology indications."
The designs, outlined below from the accepted abstracts, will be presented during two separate poster sessions:
A randomized, parallel-dose Phase I study of onapristone (ONA) in patients (pts) with progesterone receptor (PR)-expressing canceri
About Breast Cancer
In the United States, over 232,670 new cases of invasive breast cancer are expected to be diagnosed in women and over 2,360 new cases are expected in men during 2014.iii After cancers of the skin, breast cancer is the most frequently diagnosed cancer in women.i More than 40,430 breast cancer deaths are expected in 2014, with the vast majority in women. Breast cancer ranks second as a cause of cancer death in women, following lung cancer.i
About Endometrial Cancer
In the United States, about 52,630 cases of cancer of the uterine corpus (body of the uterus) are expected to be diagnosed in 2014. These usually occur in the endometrium (lining of the uterus).i About 8,590 deaths are expected in 2014.i
About Prostate Cancer
In the United States, prostate cancer is the most frequently diagnosed cancer in men aside from skin cancer. An estimated 233,000 new cases of prostate cancer will be diagnosed during 2014 in the U.S. alone. With an estimated 29,500 deaths expected to occur in 2014, prostate cancer is the second-leading cause of cancer death in men.i
On the global scale, prostate cancer is the fourth most common cancer in both sexes combined and the second most common cancer in men.iv Worldwide in 2012, an estimated 1.1 million men were diagnosed – accounting for 15 percent of the cancers diagnosed in men – and there were an estimated 307,000 deaths, making prostate cancer the fifth leading cause of death from cancer in men (6.6% of the total men deaths).ii
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, statements regarding the potential of onapristone as a treatment for breast, prostate and other cancers, statements regarding whether Arno"s clinical studies will establish a relationship of activated PR as a predictive biomarker to preliminary efficacy of an anti-progestin, statements regarding Arno"s use and development of a diagnostic test to identify patients with APR tumors, 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 successfully develop a diagnostic to identify APR tumors, 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, 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.
iCottu, P.H. et al. "A randomized, parallel-dose phase 1 study of onapristone (ONA) in patients (pts) with progesterone receptor (PR)-expressing cancers." Abstract TPS2643 / Poster 98B to be presented at the ASCO Annual Meeting during a poster session on June 1, 2014.
iiMateo, J. et al. "A phase 1-2 study of the type I progesterone receptor (PR) antagonist, onapristone (ONA), in patients (pts) with advanced castration-resistant prostate cancer (CRPC)." Abstract TPS5097 / Poster 224B to be presented at the ASCO Annual Meeting during a poster session on June 2, 2014.
iiiAmerican Cancer Society. Cancer Facts & Figures 2014. Available at: http://www.cancer.org/acs/groups/content/@research/documents/webcontent/acspc-042151.pdf
ivInternational Agency for Research on Cancer. GLOBOCAN 2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2012. Available at: http://globocan.iarc.fr/Pages/fact_sheets_cancer.aspx
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