Talaris Advisors Contracts with NMPI for Diabetes Drug Development

Oct. 21, 2009 - PRLog -- Talaris Advisors, LLC, today announced it has been engaged by NMPI, LLC, to develop its novel approach for the treatment of diabetes.  Utilizing technology developed by Dr. Guo-Ping Shi, a Harvard scientist and leader in the field of cysteine proteases in human biology, NMPI is focused on advancing novel drugs that inhibit the Cathepsin L (CatL) pathway.  The prevalence of diabetes continues to grow and today affects over 24 million people in the US alone.  Global sales of diabetes drugs were over $15 billion in 2005.

In partnering with Talaris Advisors, NMPI is able to rapidly accelerate its development plan and drive to key milestones, and yet continue to operate in a capital-sparing manner as a virtual company.  Talaris will manage non-clinical, Investigational New Drug(IND)-enabling studies in diabetes focusing on Cathepsin L.  These proof-of-concept studies are aimed at demonstrating the efficacy in the gold standard models.  Talaris will then manage pharmacology and toxicity studies to support the filing of an IND, prepare and submit the IND, and oversee the preparation, implementation and management of the Phase I clinical studies.  Talaris will also oversee manufacturing of clinical trial material.

Dr. Shi and colleagues published the first scientific paper regarding the possibility of using cathepsin inhibitors to treat human disease (Chapman, HA, Riese, RJ, Shi, G-P. Emerging roles for cysteine proteases in human biology. Annu. Rev. Physiol. 1997).  He was the principal investigator in the paper published in Nature Cell Biology disclosing for the first time the link between Cathepsin L and obesity and diabetes (Cathepsin L activity controls adipogenesis and glucose tolerance, Nat. Cell Biol., 2008).  CatL inhibition is a potential means of treating the inflamed fat cells and restoring the function of certain damaged proteins including the insulin receptor necessary for reducing serum levels of insulin and glucose.

Speaking on behalf of NMPI, co-founder Rob Gregory stated, “We are pleased to be working with Talaris and their innovative approach to drug development.  For a start-up company like NMPI, we are able to access the needed strategic expertise for our program, but to do so on an out-sourced basis.  The Talaris approach is expected to save us time and money by avoiding the ramp-up, hiring, integration and execution delays and costs, and to accelerate the achievement of key, value-building milestones.  By working with Talaris, we hit the ground running and get immediate, on-demand expertise integrated across all of the required functions necessary to take our drug through to proof-of-concept.  This novel, turn-key model provides many attractive benefits in drug development.”

About Talaris Advisors:
Talaris Advisors, LLC is the one-stop solution for drug, diagnostic and device development worldwide bringing significant flexibility and efficiency to our clients through turn-key management solutions.  The Company focuses on assisting emerging, technology-driven healthcare companies attain key milestones to reach key value inflection points through strategic, turn-key drug development services.  Talaris provides the full spectrum of drug development and project management capabilities, including management of drug discovery and medicinal chemistry, non-clinical, cGMP manufacturing/scale-up, regulatory/quality and medical/clinical development.


About NMPI:
NMPI, founded in 2004 by Dr. Guo-Ping Shi and Robert Gregory, today operates as a virtual company.  Dr. Shi is one of the pioneering scientists in the study of cathepsins and the discoverer of Cat S (1992) and Cat K (1995).  Patents covering these therapeutic treatments extend until 2027.  Dr. Shi’s discoveries identify for the first time a single therapeutic target that addresses the paradox of the metabolic syndrome with its clustering cardiovascular risk factors, such as type 2 diabetes, hypertension, high triglyceride and low high density lipoprotein cholesterol.  The findings published in Nature Cell Biology address in a single target both central obesity and insulin resistance which are the underlying disorders of the syndrome as well as further risk factors for cardiovascular disease.

About Diabetes:
Type 2 diabetes (diabetes mellitus) is a metabolic disorder in which blood glucose levels fluctuate due to the failure of the body to produce adequate levels of insulin to meet its needs.  Approximately 24 million children and adults in the United States, or 7.8% of the population, have diabetes. While an estimated 17.9 million have been diagnosed with diabetes, The American Diabetes Association estimates that 5.7 million people (or nearly one quarter) are unaware that they have the disease.(1) Global sales of diabetes drugs totaled $15 billion in 2005(2).  
In type 2 diabetes, patients develop resistance to the effects of insulin, and obesity is the chief risk factor in developing type 2 diabetes as 80-90% of patients with type 2 diabetes are obese. Diabetes symptoms include increased urination, thirst, and weight loss. Diabetes also can lead to nerve damage, blood vessel damage, and increased risk of heart attack, stroke, and kidney failure. About 15% of people over the age of 70 develop Type 2 diabetes.  Treatment of diabetes involves diet, exercise, education, and, for most people, drugs.  

Obesity is the excess accumulation of body fat and is defined as having a Body Mass Index(3) more than 30.  Obesity increases the risk of many disorders, such as diabetes, heart disease, and certain cancers, and can result in high blood pressure and early death. Increasing activity and reducing caloric intake are essential to treating obesity, but some people also need to take drugs.  Thirty percent of adults in US are obese and frequently have hypertension, type-2 diabetes, dyslipidemia, or atherosclerosis, conditions that pose serious threats to public health.(4) Approximately 10% of the world population is obese(5).  Sales of obesity drugs in the world’s largest markets are expected to grow from $500 million in 2006 to more than $2 billion by 2016(6).
1  http://www.diabetes.org/diabetes-basics/
2  “The Global Diabetes Market – Therapeutics, Diagnostics, and Complications” Arrowhead Publishers
3 Body Mass Index = (weight in kilograms)/(length in meters)
4 Evans, R.M., Barish, G.D., & Wang, Y.X. PPARs and the complex journey to obesity. Nat. Med.  10, 355-361 (2004). Stemming the Obesity Epidemic: A Tantalizing Prospect J. Lennert Veerman et als Obesity (2007) 15, 2365–2370.
5 World Health Organization estimates from 2005
6 Decision Resources, March 2008

Talaris and the Talaris logo are trademarks of Talaris Advisors, LLC

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Talaris Advisors, LLC is the one-stop solution for drug, diagnostic and device development worldwide bringing significant flexibility and efficiency to our clients through turn-key management solutions. The Company focuses on assisting emerging, technology-driven healthcare companies attain key milestones to reach key value inflection points through strategic, turn-key drug development services. Talaris provides the full spectrum of drug development and project management capabilities, including management of drug discovery and medicinal chemistry, non-clinical, cGMP manufacturing/scale-up, regulatory/quality and medical/clinical development.