IITRI's Drug Testing Services Based on
40-Years of Cutting-Edge Cancer Research

Discovering and developing new drugs to treat cancer is a time-consuming and costly process. Only one in 5,000 potential cancer drugs or fewer will make it to FDA approval, according the National Cancer Institute's "Plans and Priorities for Cancer Research" (2004).

Cutting-edge research methods and experienced, knowledgeable scientists are essential assets in the race to develop and market new therapeutics. With a 40-year history in the research of cancer prevention and therapy, IITRI offers pharmaceutical customers the edge they need to successfully navigate the drug development process.

IITRI Studies Surpass FDA Requirements

IITRI has been working closely with the National Cancer Institute (NCI) since the early 1960s to advance our understanding of cancer biology, and to develop novel agents for cancer prevention and therapy. Disease targets have included cancers of the breast, prostate, colon, lung, skin, urinary bladder, head and neck, and hematopoietic system. The many classes of agents studied have included retinoids, hormones and anti-hormones, anti-inflammatory agents, angiogenesis inhibitors, histone deacetylase inhibitors, vitamin D analogs, and a wide range of natural products with anticancer activity. A substantial number of these initiatives have led to clinical studies conducted by the NCI or by companies who have partnered with the NCI in drug development.

In April 2004, IITRI was awarded a $17.3 million contract with the Division of Cancer Treatment at NCI to advance the development of novel cancer therapeutics. This program in cancer therapy was followed later in 2004 by two more awards (for $4.5 and $6.3 million) from the NCI Division of Cancer Prevention to support drug screening and preclinical toxicology studies of cancer chemopreventive agents. (See article in IITRI's Life Sciences Today newsletter.)

IITRI's work with NCI is fundamentally based on protocols that meet FDA requirements for new drug development. Beyond these requirements, the programs often include more exploratory endpoints and state-of-the-art technologies, such as microarray and proteomic analyses. As such, IITRI has remained at the cutting edge of advances in drug development. This experience and know-how is a considerable advantage in the commercial market.

IITRI Labs Perform Comprehensive Testing Services

Once a compound has shown efficacy in halting or slowing the production of cancer cells in vitro, IITRI scientists perform tests to determine that the same pharmacologic effect can be achieved in vivo without introducing severe toxicity. These initial tests can quickly identify compounds that are unusable due to toxicity, thus saving sponsors the expense of further research.

If initial results are encouraging, scientists conduct a more detailed series of toxicology and pharmacology studies to characterize drug toxicity, determine dose-response relationships and examine drug and metabolite levels in the blood and tissues. As required by regulatory agencies, these studies are conduced in full compliance with Good Laboratory Practice (GLP) regulations.

In addition to a wide variety of in vitro and transplantable tumor models that are suitable for drug screening and efficacy evaluations, IITRI offers a broad range of in vivo primary cancer models. These models include animal models for cancer of the:

• Breast
• Esophagus
• Hematopoeitic System
• Liver
• Lung and Trachea
• Oral Cavity
• Prostate
• Skin
• Urinary Bladder

IITRI Offers Highly Skilled Staff and Fully Equipped Facilities

• IITRI studies are led by experienced, Ph.D. or D.V.M. toxicologists with many years of experience in drug development.
• IITRI can integrate biochemical and molecular studies into toxicology study designs.
• IITRI's analytical team provides complete analytical chemistry and pharmacokinetics support on-site, using state-of-the-art instrumentation, including LC, GC, LC/MS, and LC/MS/MS, combined with virtually every standard type of detection system.
• IITRI's molecular biologists have extensive expertise in studies of gene expression, using microarray, polymerase chain reaction, and other technologies.
• IITRI will soon (8/2005) complete a major facility expansion that will create 30,000 square feet of new laboratory space to support drug development studies.

Please visit our Research Services web page or contact us at LSGInfo@IITRI.org for more information on the studies we perform.