Arno Therapeutics, Inc. (ARNI-OTC: BB)

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December 12, 2008 Issue

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Arno Therapeutics Has Three Exciting Compounds In The Area Of Oncology - Their Lead Compound AR-67, A Third Generation Camptothecin Is Entering Phase II. AR-12 An Oral PDK1 Inhibitor That Blocks The PI3K/Akt Pathway And AR-42 An Oral Pan-DAC/Akt Inhibitor Are Scheduled For IND Filings And First Humans In Phase I Studies By The 1^st Half Of 2009

Company Profile:

Arno Therapeutics, Inc. is a clinical-stage biopharmaceutical company that develops and commercializes innovative products for the treatment of cancer patients. Arno's lead clinical development compound is AR-67, a novel, third-generation camptothecin analogue that has completed patient enrollment of its Phase I study in patients with advanced solid tumors. AR-67 has demonstrated high preclinical potency and improved pharmacokinetic properties when compared with marketed second-generation products in its class. A Phase II study is anticipated to open in 2009. Arno is also developing two pre-clinical compounds. AR-12 is a potential first-in-class, orally available PDK1 inhibitor that blocks the PI3K/Akt pathway. AR-12 is undergoing IND-enabling studies. AR-42 is an orally available, targeted inhibitor of the Pan-DAC and Akt pathways also undergoing IND-enabling studies. Both AR-12 and AR-42 are expected to begin enrollment in Phase I studies by the middle of 2009.

BIO:
Roger G. Berlin, MD, FACP, FACG - Chief Executive Officer

Dr. Berlin has over 20 years of drug development experience in multiple therapeutic categories, which have led to numerous NDA, sNDA and MRP approvals. Prior to joining Arno Therapeutics, Dr. Berlin was President, Global R&D at Wyeth Consumer Healthcare, the $2.7 billion non-prescription division of Wyeth, from 1998 to 2008, previously serving in various positions of increasing responsibility since 1994. While at Wyeth, Dr. Berlin was responsible for the development and successful clinical testing and registration of multiple NDAs, sNDAs and MRP approvals. He led a 400+ person organization comprised of diverse functions including clinical research, medical affairs, biostatistics, regulatory affairs, formulation and analytical development, project planning and new business development. Dr. Berlin served on the divisional senior leadership team, was an instructor for the corporate leadership training program, served on the Consumer Health Products Association scientific leadership group and was Wyeth's lead presenter for several key FDA advisory committee meetings.

Prior to joining Wyeth, Dr. Berlin served in a variety of leadership roles in prescription drug development at Merck from 1985 to 1994. He was head of global clinical research operations, a group of approximately 225 that conducted clinical studies in all therapeutic areas worldwide. In 1994, he led the first external course for the Chinese FDA that covered GCP, clinical study design and data interpretation. Previous to that assignment, Dr. Berlin was head of international regulatory liaison, responsible for registration strategy development and execution in a wide variety of therapeutic areas. During his time at Merck, Dr. Berlin served on many key leadership committees and groups and was involved in two inter-company collaborations that led to successful marketed products. Prior to his tenure at Merck, Dr. Berlin was in private practice in the area of gastroenterology.

Dr. Berlin holds a BS in Biology from Queens College, CUNY, an MD from Cornell-Weill Medical College and completed the Harvard Business School Advanced Management Program. He serves on the advisory board of the Pharmaceutical MBA program at the University of the Sciences in Philadelphia and JRG Ventures. Dr. Berlin received research grants from NIH and the Bank of America-Giannini Foundation. He has published extensively, served as a reviewer to numerous journals and served on the national research committee of the American Gastroenterological Association.

Healthcare
Biotechnology
(ARNI-OTC: BB)

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Arno Therapeutics, Inc.

4 Campus Drive, 2^nd Floor

Parsippany, NJ 07054
Phone: 862-703-7175
of 862-703-7176

Brian Lenz, CPA, Chief Financial Officer

Interview conducted by: Lynn Fosse, Senior Editor, CEOCFOinterviews.com, Published – December 12, 2008

CEOCFO: Dr. Berlin, you have a long history in the industry; what attracted you to Arno Therapeutics?
Dr. Berlin: “I was excited by the portfolio of compounds that Arno Therapeutics has and the fact that there are tremendous opportunities in the area of oncology to positively affect the lives of the patients that have cancer. Our portfolio of three compounds offer a very interesting mix of therapeutic agents. Our lead clinical development compound is AR-67. This is a third generation camptothecin with a proven mechanism of action, but with improved properties based on good medicinal chemistry design. We also have AR-12, which is an oral potentially first-in-class PDK1 inhibitor that targets the PI3Kinase/Akt pathway. The third compound is AR-42, an oral Pan-DAC and Akt inhibitor. AR-67 is already in the clinic and entering Phase II. AR-12 and AR-42 are scheduled for IND filing and first in man by the middle of 2009.

We are a company of six people and by the middle of 2009 we expect to have three very interesting and promising cancer drugs in patients This is very unusual for a company our size.”

CEOCFO: What is special about the compounds that you are working with?

Dr. Berlin: “Our lead compound is furthest along in clinical testing. It is a compound that causes breaks in DNA by attaching to the DNA. This leads to cell death and is a way of targeting rapidly dividing cells and causing their death; in other words, you preferentially target cancer cells. We know this class of compounds, camptothecins, has been proven effective. There are two approved drugs in this class in the United States and they account for about ~$1.2 billion in sales. What we are doing is working on a compound where the basic mechanism has been proven, but where the properties of the compound are improved. Therefore, we think it has the potential to be better tolerated and more effective then the currently marketed drugs in this class.

The second compound is a ‘targeted agent’. There are many signaling pathways in cells. These signaling pathways are disordered in cancer and there are a variety of drugs that are now either approved or being developed which specifically target abnormal signaling pathways in cancer cells. AR-12 targets something called PDK1, which is part of the PI3Kinase/Akt signaling pathway. By blocking the action of PDK1, it prevents the next molecule in that signaling pathway, Akt, from being activated, and by preventing AKT from being activated; it leads to cell death, control of cell proliferation and has other effects. We know this is a very important pathway and there are theoretical advantages to targeting the pathway at this particular point. We are moving toward IND filing and the first patient receiving this agent by the middle of 2009.

The third of our portfolio of compounds targets a variety of pathways that are disordered in cancer cells. It blocks the addition of specific molecules to histones that control the way DNA is expressed. It also inactivates the Akt pathway and it has other actions. It interferes with the mechanism of repair for double-strand DNA breaks. This orally acting molecule acts on a variety of different pathways within the cancer cell to lead to the cancer cell death.

CEOCFO: Are there particular types of cancer that your products would target or is it universal?

Dr. Berlin: “We are choosing to look at certain targets but that doesn’t mean those would be the only places these compounds work. For AR-67 we just completed enrollment for this Phase I trial and we now understand what are the dose limiting toxicities and maximum tolerated dose. Our first Phase II trial will be in MDS (Myelodysplastic syndrome). For compounds like AR-12 and AR-42, which target specific pathways, in Phase I we will be able to look at some measures of the activation of these pathways to determine not only the dose limiting toxicity and the maximum tolerated dose, but also to begin the validation that these drugs work on the targets at the dose levels we are able to achieve in humans. We have a great deal of preclinical data that suggests that AR-12 is very effective when added to other widely used anti-cancer drugs. Using these newer agents in combination with AR-12 we hope will improve the response.”

CEOCFO: When you do the testing, do you test with all of the other drugs that it would be working with or is it more isolated?

Dr. Berlin: “We test a variety of drugs; we don’t test every drug because it is not feasible to do that. In humans, based on preclinical data, we will select a few drugs to be tested in combination with our drug because it will validate the information that we generated in the preclinical study.”

CEOCFO: Is there much competition in the particular areas that you are looking in terms of new drug developments?

Dr. Berlin: “There is tremendous interest in cancer therapy, so there is a lot of competition in the area. I think it reflects the fact that cancer is such an important target and has such an affect on patients’ lives. We think we have a chance of being the first PDK1 inhibitor with AR-12. We believe that AR-42 may be unique in this class of compounds as it targets a variety of pathways.”
 

CEOCFO: What is the financial picture like today at Arno?

Mr. Lenz: “We just recently filed our 3^rd Quarter 10Q. As of September 30^th we had $13.2 million in cash equivalents and we believe this is sufficient to fund the next twelve months of development. For the 9 Months ended September 30, 2008, we had a loss from operations of approximately $8.8 million with the majority of the loss of $7.1 million going to research and development.”
 

Dr. Berlin: More than 80% of our expenditures are on R&D. We are very focused to make sure our expenditures go toward the development of these three products in our portfolio. We are a very lean and efficient organization.”
 

CEOCFO: Given today’s environment what do you do going forward? Do you see partnerships; how will you continue to proceed?

Dr. Berlin: “We think that others share the excitement about the compounds in our portfolio. We have had discussions with other pharmaceutical companies that may have a potential interest in partnering with us. We very much appreciate the support of our existing investors and believe that we have the opportunity to talk with them about augmenting their investments in the company. Obviously we will continue to look for additional outside sources of funding.”

CEOCFO: There are so many companies to choose from; why should potential investors be interested in Arno?

Dr. Berlin: “We stand out because of our strong portfolio. We have moved two of these compounds, acquired in January 2008, from preclinical status to anticipated IND filing and enrollment into our Phase I trials by the middle of 2009. We are efficient with our spending and have the management expertise to succeed.”
 

CEOCFO: Final thoughts; what should people reading about Arno Therapeutics remember most?

Dr. Berlin: “We are a small company moving potentially important cancer drugs forward rapidly in an efficient fashion.”

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“I was excited by the portfolio of compounds that Arno Therapeutics has and the fact that there are tremendous opportunities in the area of oncology to positively affect the lives of the patients that have cancer. Our portfolio with its three compounds offers a very interesting mix of therapeutic agents. Our lead clinical development compound is AR-67. This is a third generation camptothecin with a proven mechanism of action, but with improved properties based on good medicinal chemistry design. We also have AR-12, which is an oral potentially first-in-class PDK1 inhibitor that targets the PI3Kinase/Akt pathway. The third compound is AR-42, an oral Pan-DAC and Akt inhibitor. AR-67 is already in the clinic and entering Phase II. AR-12 and AR-42 are scheduled for IND filing and first in man by the middle of 2009.” - Dr. Roger G. Berlin M.D. FACP, FACG