67 WALL STREET, New York - April 25, 2014 - The Wall Street Transcript has just published its Biotechnology and Pharmaceuticals Report offering a timely review of the sector to serious investors and industry executives. This special feature contains expert industry commentary through in-depth interviews with public company CEOs and Equity Analysts. The full issue is available by calling (212) 952-7433 or via The Wall Street Transcript Online.
Topics covered: Health Care - Biotechnology and Pharmaceuticals - Orphan Drug and Biologics Manufacturing - Oncology Drug Development - Orphan Drugs - FDA Approval Process - Biotechnology and Pharmaceutical Companies Valuation - Genetic and Cell Therapies
Companies include: Arno Therapeutics, Inc. (ARNI) and many more.
In the following excerpt from the Biotechnology and Pharmaceuticals Report, the President, CEO and Director of Arno Therapeutics, Inc. (ARNI) discusses company strategy and the outlook for this vital industry:
TWST: While endometrioid cancer is an area of unmet patient need, there are lots of treatments for breast cancer and prostate cancer. Tell me what's unique about your approach.
Mr. Mattes: First of all, our development approach is quite unique in the way the Phase I trials are designed. We are doing randomized dosing versus sequential dosing in both trials. We are randomly assigning patients who are enrolled into each trial to the different dose strengths that we are testing. This rollout is a Phase I trial, but it's being done in a much more efficient way.
As a therapy though, what's quite unique about onapristone comes back to two significant points. Number one is the lead indications that we are going after. As a small biotech company, we need to be quite efficient in managing our resources and focusing on our speed to the market. We are focused on those indications that we think have the greatest opportunity for a more rapid development approach, and that led us to endometrioid cancer, which we believe presents the most rapid path to the market.
And then, the companion diagnostic will ultimately allow us to efficiently screen those patients who are more likely to benefit from treatment with onapristone. Also on a parallel path, the companion diagnostic is being developed and will be used in the trials to identify those patients who test positive for the activated form of the progesterone receptor or APR biomarker.
We have already solidified our working relationships on the companion-diagnostic front; Leica Biosystems is our co-developer. I think that this is also a very unique milestone that we have already partnered with a world-class companion-diagnostic developer. Leica has a very significant presence in the companion-diagnostic arena, especially as it focuses on the specific technology that we are using for the diagnostic. Also it is our understanding that they are very selective in how they choose their pharmaceutical partners; it is notable that we were one of only three companion-diagnostic partnerships that Leica did last year.
We also have relationships with other diagnostic companies looking at other potential modalities and technologic approaches that could further refine the companion-diagnostic outcome. We have a relationship with Clarient Diagnostics, a division of General Electric; a relationship with the University of Minnesota for a gene-expression model for the diagnostic; and we have one with Veridex - which is now known as Janssen Diagnostics, part of Johnson & Johnson - looking at circulating tumor cells. These partnerships allow Arno to explore several potential paths and technologies toward refining the companion-diagnostic approach, which is ultimately aimed at identifying the best way to select the patient population.
TWST: What are your core objectives over the next 12 to 24 months and the milestones that it will take you to achieve it?
For more of this interview and many others visit the Wall Street Transcript - a unique service for investors and industry researchers - providing fresh commentary and insight through verbatim interviews with CEOs, portfolio managers and research analysts. This special issue is available by calling (212) 952-7433 or via The Wall Street Transcript Online.