CLINICAL TRIAL HOME

CLINICAL TRIAL HOME

This year, Envita revolutionized the field of natural medicine by becoming one of the first natural medical clinics to be approved by the Food and Drug Administration (FDA) for a Phase I clinical biological drug trial for the treatment of cancer.  It is unprecedented for a natural medical clinic to conduct a Phase I clinical drug trial of this sort.

Envita is committed to research, innovation, and advancing the field of natural medicine.  We are one of only a handful of clinics around the world that is moving beyond the limitations of conventional treatments and is thinking outside the box.

We hope that our Phase I clinical drug trial will lead to other ways for us to revolutionize patient outcomes and change the face of cancer treatment for the better.

What is a Phase I Clinical Drug Trial?

Clinical trials are research studies conducted in human volunteers to answer specific health questions about a new treatment or a new way of using an old treatment. They are the best and safest way for finding new and more effective therapies and for progressing the field of medicine.

There are three phases of clinical trials intended for support of a new drug or biological.  In the first phase, the safety and efficacy of the drug or biological is tested in a small number of patients, and patients are closely monitored for side effects.  The safety of the treatment is tested at various dosage levels.

In Phase II, the study is opened up to more patients, usually no more than 50, in order to further test the safety and efficacy of the study drug or biological.  The Phase II study is used to identify the optimum dose for the treatment and any related adverse events, and the production process for the product is refined.  Only if the treatment has shown success in the first two phases will the trial be permitted to progress to the third phase.

In Phase III, large numbers of patients are enrolled, sometimes numbering in the thousands.  In this phase, the sponsor of the study is seeking to establish that the new drug or biological is more effective than a placebo or no treatment.  Following successful completion of Phase III, the sponsor generally submits an application for a new drug or biologics approval to the FDA.

To learn more about clinical drug trials, click here.

To read about clinical trials from a patient’s perspective, click here.

What Does Envita’s Clinical Trial Involve?

We are studying the effect of natural killer cells on the immune system of certain cancer patients.  Our study involves removing a patient’s own natural killer cells, expanding them, and then reintroducing them to the body, which we call 4NKT treatment.

What is 4NKT?

4NKT is the name for the new biological treatment being studied in Envita’s Phase I trial.  The trial is being conducted to learn if 4NKT treatment will help cancer patients achieve healthier immune systems by supplementing their bodies with immune cells that have the ability to fight cancer.  In essence, 4NKT is akin to an immune system transplant.  Unlike organ transplants, in which organs are obtained from one person and given to another, the cells that are transplanted in the 4NKT process are actually autologous, which means they are the patient’s own cells. 

Here’s why we do it: Cancer patients usually have a very low number of natural killer cells, which are an important type of white blood cell that mainly functions to control viral infections and recognize tumor cells in the early stages of cancer.  In addition to having low numbers, the NK cells that are present in cancer patients usually don’t work properly.  This, of course, further aggravates the course of disease in these patients. 

Here’s how it works: Once we have identified a patient as being a candidate for 4NKT in the clinical trial, we use a machine called an apheresis unit to obtain billions of white blood cells from the patient.  In healthy adults, less than 8% of white blood cells are NK cells.  This number, of course, is even lower in patients with late-stage, metastatic cancer.  About 20% of the cells we obtain from the apheresis procedure cannot be expanded or re-infused back into the patient, because they are the wrong type of cell to do the job we are looking to do.  However, these cells do help the right cells grow, so they are not disposed of during the process.  They play a very important role in helping the right cells grow and mature.

Once the white blood cells are obtained, we “wash” the cells in saline to sterilize them, and then we “feed” them to keep them alive.  However, our goal is not just to keep the cells alive; we also want to train them how to fight and be productive again.  Once that is accomplished, we want to make as many of them as we can to build an army of competent, motivated cells.  To accomplish this goal, we use some FDA-approved agents called cytokines.  Cytokines are proteins that occur naturally in the body.  They are used by the cells of the immune system to talk to one another.  Each cytokine sends its own particular signal to a particular type of cell.  The cytokines we use send signals to three major types of cells: natural killer cells, natural killer T cells, and cytotoxic T lymphocytes.  Once cytokines are added, the 20% of cells that are the “wrong” type of cell produce more cytokines themselves, helping to feed the right cells and speeding up the process of expansion.  This process is conducted over a span of three to four weeks. 

The goal is to end up with billions of properly trained cells that are capable of recognizing and killing tumor cells.  But because this is only a Phase I study, the effectiveness of our treatment and our ability to consistently and successfully train and expand these cells has not been established yet.  This brief summary only describes what we hope to achieve with our experimental treatment.