Arno Therapeutics Inc.
Creating the next generation of cancer treatments
(ARNID) 
Arno Therapeutics is a biopharmaceutical company focused on the clinical development of targeted cancer therapies and novel drug candidates for unmet medical needs.
http://www.arnothera.com/index.html PIPELINE
Arno has exclusive worldwide rights to develop and market three innovative pre-clinical and clinical-stage product candidates with unique mechanisms of action. These compounds have the potential to be first-in-class products for the treatment of hematologic malignancies and solid tumors.
Onapristone
Drug Description
Onapristone is a progesterone receptor antagonist that has demonstrated anti-tumor activity in preclinical and clinical studies of hormone-dependent tumors. Its mechanism of action is thought to be a direct result of binding to the progesterone receptor and preventing the progesterone receptor from binding to DNA, thereby substantially reducing or eliminating progesterone-receptor-induced transcription resulting in death or differentiation of the malignant cells.
Development History
Onapristone was originally developed by Schering AG. Early stage clinical studies conducted in Europe in post-menopausal women with breast cancer showed encouraging anti-tumor activity but also transient elevated liver function test. Arno Therapeutics is conducting additional research to potentially identify patients who would benefit most from onapristone and has entered into a licensing agreement with Invivis Pharmaceuticals in 2012 for further development.
Clinical Findings
Onapristone has been evaluated in clinical studies as both first- and second-line treatment for primary and metastatic breast cancer. In clinical studies, onapristone has demonstrated a 56% objective response rate as a first-line endocrine treatment of breast cancer and a 49% clinical benefit rate in patients with breast cancer previously treated wiht tamoxifen. Future studies of onapristone may be conducted in combination with other endocrine agents to improve previous results observed in patients with breast cancer.
Current Development Plan
Arno plans to develop this compound for the treatment of a variety of tumor types, including breast and endometrial cancer. The company is preparing to conduct preclinical toxicology studies and has begun work on a predictive diagnostic biomarker to determine which patients would benefit most from onapristone treatment. Following completion of preclinical studies and initiation of the development of a companion diagnostic, we intend to file an IND with the FDA to begin a dose-escalation Phase I study of onapristone in patients with endometrial and breast cancer.
Select Bibliography
J.F.R. Robertson et al., Onapristone, a Progesterone Receptor Antagonist, as First-Line Therapy in Primary Breast Cancer, European Journal of Cancer, Vol. 35, No. 2, pp. 214-218, 1999.
J.G.M. Klijn et al., Progesterone antagonists and progesterone receptor modulators in the treatment of breast cancer, Steroids, v. 65, pp. 825-830, 2000.
W. Jonatt et al., The clinical efficacy of progesterone antagonists in breast cancer, in Endocrine Therapy of Breast Cancer, pp. 117-124.
AR-42
Drug Description
AR-42 is a novel, oral agent therapy currently in early clinical development. It is a broad-spectrum deacetylase inhibitor of both histone and non-histone proteins, which has demonstrated greater potency and activity in solid tumors and hematological malignancies when compared in preclinical studies to vorinostat (also known as "SAHA" or Zolinza®), the first of two marketed compounds in the class. AR-42 may possess additional histone-independent mechanisms, which may contribute to its superior profile in vitro and in vivo. It has been designated an orphan drug by the FDA for the treatment of meningioma and schwannoma of the central nervous system. Meningioma and schwannoma are rare, benign tumors that can present in different locations within the brain and the spinal cord and may cause substantial morbidity.
Development History
AR-42 was licensed to Arno in January 2008 by The Ohio State University Research Foundation for commercial development by Arno.
Preclinical Findings
In preclinical models, AR-42 has shown to be more potent or effective than SAHA in various cancer types, including chronic lymphocyte leukemia, or CLL, B-cell lymphoma, prostate and ovarian cancers. Preclinical studies suggest that AR-42 has anti-cancer activities that are independent of histone acetylation and which disrupt the growth and proliferation of cancer cells. We believe that this combination of activity and potency could make AR-42 a more effective treatment for hematological malignancies than currently available HDAC inhibitors and a potential treatment of a number of solid tumors. In addition, pre-clinical models have demonstrated anti-tumor activity in tumor types (schwannoma and meningioma) that are associated with the genetic illness neurofibromatosis type 2. Additional pre-clinical data presented at the 2009 American Society of Hematology Annual Meeting showed that AR-42 potently and selectively inhibits leukemic stem cells in acute myeloid leukemia.
Development Plan
AR-42 is currently in an investigator-initiated dose-ranging Phase I/IIa clinical trial for treatment of relapsed or recurrent hematological malignancies and solid tumors for which standard treatment has failed or not proven to be effective. The ongoing study is designed so that additional patients with hematological malignancies can be added to investigate the potential efficacy of AR-42 in a particular disease and help guide future Phase II programs once the recommended dose for further study has been defined. During 2012, we intend to collaborate with The Ohio State University to conduct an investigator-initiated study of AR-42 in patients with schwannoma and meningioma to assess intra-tumoral concentrations of AR-42, identify apoptosis markers and assess gene regulation.
CLINICAL PROGRAM
For information about the current clinical program, please Click Here
AR-12
Drug Description
AR-12 is a potentially first-in-class, orally available, targeted anti-cancer agent that has been shown in preclinical studies to inhibit phosphoinositide-dependent protein kinase-1, or PDK-1, a protein in the PI3K/Akt pathway that is involved in the growth and proliferation of cells, including cancer cells. Although FDA-approved drugs that target the Akt pathway have shown efficacy in treating cancer, some tumors either do not respond to these drugs or eventually become resistant to therapy. Scientists hypothesize that a combination of drugs that inhibit different targets in this pathway could provide synergistic or additive benefits to increase efficacy and potentially overcome drug resistance. For this reason, there has been particular interest within the biopharmaceutical industry in developing inhibitors of PI3K, PDK-1, and Akt.
Development History
AR-12 was licensed to Arno in January 2008 by The Ohio State University Research Foundation for commercial development by Arno as a potential treatment for solid tumors and hematological malignancies.
Preclinical Findings
In preclinical studies, AR-12 has shown efficacy in a wide range of tumor types, including breast, lung, prostate, pancreatic, brain and hematological cancers, as both a single-agent as well as in combination with leading oncology therapeutics. AR-12 demonstrated synergy or additive benefit or overcame drug-resistance when used in combination with Avastin®, Herceptin®, Gleevec®, Tarceva®, Iressa®, Nexavar® and tamoxifen, all of which are widely prescribed, FDA-approved oncology therapeutics that, according to Thomson Reuters Pharma, represented approximately $17 billion in sales in 2009.
Development Plan
We are currently conducting a multi-centered, two-part, Phase I clinical study of AR-12 in adult patients with advanced or recurrent solid tumors or lymphoma. The first part is a dose-escalating study to evaluate the safety of AR-12 and identify the maximum tolerated dose and recommended Phase II dose for future studies. The second part of the study was to be a cohort expansion at the recommended phase 2 dose in selected "tumor types". We will not be proceeding with the second part of the study, as we plan to develop a revised formulation of AR-12 with greater bioavailability which will require a new Phase I study to be performed.
Select Bibliography
Tseng PH et al., Mol. Pharmacol. 2006 Nov; 70(5):1534-41
Cen L et al., British J. Cancer (2007) 97, 785-791
Ping-Hui Tseng et al., Blood (2005) 105: 4021-4027
MANAGEMENT
Glenn Mattes
President and Chief Executive Officer
Mr. Mattes has been Arno's President and Chief Executive Officer since April 2011. He has over 25 years of pharmaceutical commercialization and general management experience. Before joining Arno, Mr. Mattes was President of Tibotec Therapeutics, a Johnson & Johnson company focused on oncology and virology therapeutics, where he led the organization responsible for the development, marketing and sales of novel antiretroviral compounds in North America. Under his leadership, Tibotec successfully launched Johnson & Johnson's first two U.S. HIV/AIDS products. In 2008, Mr. Mattes was appointed to the President's Advisory Council on HIV/AIDS (PACHA) by the U.S. Secretary of Health and Human Services to provide counsel on both domestic and global health and treatment issues. Prior to running Tibotec, Mr. Mattes served as Vice President of Worldwide Commercial Operations at Centocor, where he played a critical role in defining Centocor's business strategy and was responsible for the organization's sales and marketing strategy supporting the introduction of Remicade®. Prior to joining Centocor, Mr. Mattes worked at Rhone Poulenc Rorer (RPR) (now Aventis), where he held positions of increasing responsibility, including President of RPR Canada and Vice President of Advanced Therapeutics and Oncology, North America, where he was responsible for the successful launch of Taxotere® and Lovenox®.
Alexander Zukiwski, MD
Vice President and Chief Medical Officer
Dr. Zukiwski is responsible for leading the clinical development and regulatory affairs teams supporting Arno’s current and future pipeline of innovative cancer therapies. He has more than 15 years of experience in global oncology drug development and has supported the clinical evaluation and registration of many successful therapeutic agents, including Taxotere®, Xeloda®, Procrit®/Eprex®, Velcade®, Yondelis® and Doxil®. Dr. Zukiwski was most recently Executive Vice President, Clinical Research, and Chief Medical Officer at MedImmune, Inc. where the organization he led was responsible for developing and implementing MedImmune's clinical research, medical affairs and safety strategies. Prior to joining MedImmune, Dr. Zukiwski held medical affairs and clinical development positions of increasing responsibility at Johnson & Johnson Pharmaceutical Research & Development, LLC (JJPRD), Centocor and Ortho Biotech, including serving as therapeutic area head for oncology and acting head of oncology research and development. Before joining Johnson & Johnson, Dr. Zukiwski held clinical oncology positions at Hoffmann-LaRoche, Glaxo Wellcome and Rhone- Poulenc Rorer. He received a bachelor’s degree in pharmacy from the University of Alberta and a Doctor of Medicine degree from the University of Calgary and conducted post- graduate training at St. Thomas Hospital Medical Center in Akron, Ohio and the University of Texas, M.D. Anderson Cancer Center.
Stefan Proniuk, PhD
Vice President Product Development
Dr. Proniuk has over 15 years of experience in pharmaceutical product development. In his current role, he is responsible for the preclinical, chemical and pharmaceutical development of Arno's portfolio. Dr. Proniuk has extensive development experience across multiple therapeutic areas and dosage forms and has participated in the submission of 13 INDs/CTAs/IMPDs and 2 NDAs. Prior to joining Arno, he was the Senior Manager of Pharmaceutical Technologies at Neurocrine Biosciences (2002-2008) where he was responsible for overseeing development programs from Phase I to commercial launch and was also appointed to lead the pharmaceutical sciences group. Previously, Dr. Proniuk worked as a scientist at Cima Labs (2001-2002) on the development and scale-up of orally disintegrating tablet formulations (Niravam®, Triaminic®). Dr. Proniuk holds a Ph.D. degree in Pharmaceutical Sciences from the University of Arizona, an M.B.A. from San Diego State University and a Diplom (FH) in Chemical Engineering from the University of Applied Sciences Isny in Germany
ARNID Security Details
Share StructureMarket Value1 $11,837,281 a/o Oct 28, 2013
Shares Outstanding 39,457,602 a/o Aug 12, 2013
Float Not Available
Authorized Shares Not Available
Par Value 0.0001
ShareholdersShareholders of Record 251 a/o Apr 01, 2013
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