The Science

Our testing, functional profiling, is a laboratory technique that measures how cancer cells respond when they are exposed to drugs and drug combinations.

 

We have survival curves comparing the survival of patients who tested sensitive to the agents they received, compared with those who were found resistant to the treatments that they received.

 

Dr. Nagourney, his team and colleagues have published a number of papers supporting the use of our functional profiling assay, as well as the effectiveness of new drugs and combinations.

Microscope

Most Effective and Least Toxic Treatment

Currently, hundreds of drugs, drug combinations, and targeted agents are used to treat cancer patients. With so many choices, how does your oncologist decide which ones are right for you?

Generally, oncologists use established regimens developed through randomized clinical trials to prescribe chemotherapeutic agents. These regimens are average solutions for the “average” patient.

Regrettably, average treatments provide average outcomes, with the majority of patients failing to show significant improvement from these protocols.

Cancer is Unique

Each cancer patient is unique and their response to therapy is very different from one person to the next.  Drugs that work for one patient may not work for another, even if they carry exactly the same diagnosis. 

One way to help identify the best treatment option for you is to submit a living sample of your cancer cells for what we call a "functional profile".

Functional Profiling With Our EVA-PCD Assay

Functional profiling is very different from genomic testing which is offered by most medical centers.  Genomic testing looks for mutations and other changes in each patient's gene makeup that might guide drug selection.  Although the concept is appealing, in reality, a minority of patients have genetic changes that can be used for therapy.

Functional profiling is a laboratory technique pioneered by Dr. Robert Nagourney, founder of Nagourney Cancer Institute, that measures how cancer cells respond when they are exposed to drugs and drug combinations. 

We call it the Ex-Vivo Analysis of Programmed Cell Death (EVA-PCD) assay.

Programmed Cell Death is the Key

Put simply, it is a real-time measure of which drugs cause your cancer cells to die, through a process called programmed cell death.

By using this approach, we can determine in the laboratory the best drugs for each patient before they receive them.

The selection of drugs/agents used for testing are disease-specific and based on your diagnosis and previous treatment history.

We can customize the drugs tested based on your oncologist’s request.

A standard panel consists of 8 – 16 drugs/combinations. 

Creating a Predictive Human Tumor Model

Cancers arise from cells that have learned certain tricks to enhance their survival so they can outlive their normal counterparts. 

These transformed (cancerous) cells interact directly with their micro-environment.  

Cancer cells "talk" to each other and to all the surrounding cells using chemical signals like growth factors and byproducts of metabolism.  Blood vessels, immune cells, and connective tissues (stroma) all participate and contribute to the cancer process.

This is why it is absolutely essential to test cancers in their own natural clusters known as "microspheroids".  We isolate these three-dimensional structures directly from each patient's cancer specimen to test drugs and combinations.  

These microspheroids represent cohesive populations that interact directly with stroma, vasculature, inflammatory cells, and other tumor cells. Thus, the microspheroid recapitulates the human tumor environment.

By applying cell death endpoints (the most rigorous of predictive measures) to these microspheroids, we have overcome pitfalls encountered by earlier technologies.  Put simply, it is a real-time measure of which drugs cause your cancer cells to die, through a process called programmed cell death.  By using this approach, we try to determine in the laboratory the best drugs for each patient before they receive them.

And, for the first time, a truly predictive human tumor model that we call the Ex Vivo Analysis of Programmed Cell Death (EVA-PCD) assay has been developed.

The Critical Path from Bench to Bedside

For over 20 years, Dr. Nagourney and the team here at Nagourney Cancer Institute (formerly Rational Therapeutics) have been cost-effectively assisting pharmaceutical and biotechnology firms streamline the research process and more rapidly provide information not available within the current drug development process.

What We Can Do For You

Nagourney Cancer Institute has developed a human tumor primary culture platform (called EVA-PCD) for the study of drugs, biologic agents, radiation and drug combinations.

Cells isolated from surgical biopsies, peripheral blood, fluids and bone marrow aspirates are examined for drug-induced programmed cell death.  Incorporating the complexity of cell death, this platform measures both apoptotic and non-apoptotic events. 

Our laboratory has the capacity to obtain fresh, viable specimens for the isolation of micro-spheroids that have proven reflective of the clinical behavior of human tumors. 

Nagourney Cancer Institute has experience in drug development and drug synergy analysis, and has successfully applied these platforms to study the disease-specific efficacy of novel molecules.

Lower Your Costs Dramatically

Our low-cost EVA-PCD functional platform allows us to analyze the activity of your new compounds in multiple disease types at a fraction of the cost of other research avenues, identifying the most responsive diseases and eliminating tumor types with little activity.

Additionally, we can explore combinatorial potential, as well as synergy and sequence dependence. 

A recent analysis in Forbes magazine stated that the cost to bring a new drug to market has reached $5 billion.

While the cost of each individual compound comes closer to $350 million, the fact that 95 percent of new agents fail to achieve FDA approval burdens the industry with enormous un-recouped R&D expenses. 

Streamline Your Development

As the costs of drug development continue to climb, the early identification of disease specific, combinatorial and synergy analyses could streamline clinical development and curtail unnecessary expenditure of resources in getting your new compounds to market. 

Proven Results

Having proven the capacity of this platform to predict the activity of drugs like 2-CDA,[1] the Gemcitabine plus CDDP combination[2] and the EGFr antagonists,[3]Nagourney Cancer Institute is actively engaged in the study of the newest classes of compounds which target a wide variety of cellular signaling pathways.

 

Our EVA-PCD platform has been successful in the identification of a novel small molecule WNT inhibitor as reported in the lead article in PNAS April 2011.[4]  Click here for the article.

The EVA-PCD platform has been shown to correlate with clinical response, time to progression and survival in hematologic and solid tumors[5].

It provided a two-fold improvement in response (p = 0.0015) and near two-fold improvement in median overall survival (21.3 vs. 12.5 month) in previously untreated metastatic NSCLC3.

A meta-analysis of 2,581 patients revealed a 2.04 fold improvement in response and 1.44 fold improvement in 1 year survival.[6] 

Call us today at 800-542-4357 or email us through our Contact Us page to inquire about working with Dr. Nagourney and the team at Nagourney Cancer Institute to streamline your clinical development, curtail costs and get your novel agents to market sooner.

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Survival Curves

Stack of Magazines

Published Papers

Test Tubes

Assay-Directed Therapy

Doctors

Physician

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Nagourney Cancer Insitute is managed by Rational Therapeutics, LLC.  EVA-PCD, Target Rx, and Translational Rx are registered trademarks of Rational Therapeutics.

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