Arno Therapeutics, Inc. (ARNI-OTC: BB)
December 12, 2008 Issue
The Most Powerful Name In Corporate News and Information
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 1st Half Of 2009
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.
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.
Arno Therapeutics, Inc.
4 Campus Drive, 2nd Floor
Parsippany, NJ 07054
Brian Lenz, CPA, Chief Financial Officer
Interview conducted by: Lynn Fosse, Senior Editor, CEOCFOinterviews.com, Published – December 12, 2008
CEOCFO: What is special about the compounds that you are working with?
“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.
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?
“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
CEOCFO: What is the financial picture like today at Arno?
“We just recently filed our 3rd Quarter 10Q. As of September 30th
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
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?
“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
CEOCFO: Final thoughts; what should people reading about Arno Therapeutics remember most?
Berlin: “We are
a small company moving potentially important cancer drugs forward rapidly in
an efficient fashion.”
“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
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