Clinical trials

Immunicom is currently conducting clinical trials at world’s leading hospitals to evaluate the investigational use of our LW-02 column to treat different cancers. We expect to initiate additional clinical trials in the future.

What is a Therapeutic Device Clinical Trial?

Before certain types of therapeutic device can be approved for use by doctors and patients, they must be carefully evaluated in one or more clinical investigations.

Clinical trials (also known as clinical investigations or clinical research studies) help doctors and researchers determine if certain types of therapeutic devices are safe and effective in helping treat different medical conditions.

Can I Participate in a Therapeutic Device Clinical Trial?

If you meet specific requirements, then you may be eligible to participate in a study. The study doctor and his/her support team will determine if you can qualify.

Before you can participate, you will need to provide written informed consent after you review all relevant information about the study including the requirements, potential risks, alternative forms of treatment, financial support, the use and protection of your personal health data and other information.

You also will have the opportunity to ask questions. And, even if you choose to participate, you can change your mind at any time and not have any obligation to continue to participate without affecting your other medical care.

Does Immunicom have any ongoing
Therapeutic Device Clinical Trials?

Yes, Immunicom is currently recruiting patients for three (3) studies evaluating the investigational use of our LW-02 column to treat different cancers.

Women with Triple-Negative Breast Cancer

This study is being conducted at several hospitals across Poland



Men and Women with Non-Small Cell Lung Cancer

This study is being conducted in one hospital in Istanbul, Turkey



Men and Women with Melanoma, Triple-Negative Breast Cancer, Non-Small Cell Lung Cancer and Renal Cell Carcinoma

This study is being conducted at the Sheba Medical Center in Ramat Gan, Israel

What is the LW-02 Column?

The LW-02 column is an investigational therapeutic device used in Immunicom’s Immunopheresis® therapy. Because it is investigational, it has not been approved by the US Food and Drug Administration (FDA) for the treatment of cancer.

The LW-02 column removes specific blood factors that prevent the body’s own immune system from fighting certain cancers. Immunopheresis therapy has been given Breakthrough Device Designation by the US Food and Drug Administration (FDA) which means that it has the potential to more effectively treat life-threatening cancers.

The LW-02 column has been granted a CE Mark, approving its use in Europe for adults with advanced, refractory, triple-negative breast cancer. However, the use of the LW-02 column in Immunopheresis is still considered investigational in all Immunicom’s ongoing clinical research studies.

What is Immunopheresis®?

Immunopheresis® is Immunicom’s patented technology that uses an existing form of blood filtering treatment called therapeutic apheresis (like dialysis) with our investigational LW-02 column to remove specific blood factors. It is believed that by removing these blood factors, it will allow the body’s own immune system to fight certain cancers.

To learn more about Immunicom’s Immunopheresis therapy, click the button below.

Diagram of imunopheresis process

Learn more about targeted cancer
types and clinical trials

Triple-Negative Breast Cancer

Non-Small Cell Lung Cancer

Renal Cell Carcinoma

Melanoma

What is Triple-Negative Breast Cancer?

Triple-negative breast cancer (also called TNBC) is a type of breast cancer that does not respond to the same anticancer treatments as other types of breast cancers because the cancer cells are missing three more common types of receptors found on other types of breast cancer cells.

Up to 20% of all breast cancers are triple-negative. Unfortunately, triple-negative breast cancer is often not diagnosed early and is difficult to treat. Triple-negative breast cancer is more likely to affect younger people, particularly African-Americans and Hispanics and those with a certain gene mutation called BRCA1.

The good news is that doctors and researchers continue to learn more about triple-negative breast cancer. New discoveries and improved treatments are available to sometimes cure it if it is found early and to help slow down the disease if it is more advanced and spreads into other places in your body.

Immunicom is supporting the battle against breast cancer; we have two clinical research studies that are actively recruiting patients with advanced triple-negative
breast cancer.

Additional information about triple-negative breast cancer can be found at these websites:

Information About Immunicom’s Clinical Research Studies

If you or a loved one is interested in participating in one of our clinical research studies that is actively recruiting patients, you can learn more by reviewing the information presented below and clicking on the links that will provide more detailed information.

CP7 – 005

Conducted at several hospitals in Poland

CP7 – 007

Conducted at Sheba Medical Center in Israel

ELIGIBILITY CRITERIA

  • At least 18 years old and diagnosed with triple-negative breast cancer
  • Have triple-negative breast cancer that is metastatic (has spread in the body)
  • Already have had at least one other treatment that did not stop the cancer from spreading or worsening

What is Non-Small Cell Lung Cancer?

Non-Small Cell Lung Cancer (also referred to as NSCLC) is the most common type of lung cancer. There are three main subtypes of non-small cell lung cancer based on their microscopic picture. Although, they are different, most of the subtypes of non-small cell lung cancer usually respond to the same forms of treatment.

Non-small cell lung cancer occurs more frequently in black men than white men, but white women are more likely to develop the disease than black women. Non-small cell lung cancer is a difficult cancer to treat, however, important advances in the treatment include surgery, systemic therapy and radiotherapy, which have been shown to improve survival and even allow a cure, particularly if the cancer is detected early before it spreads throughout the body. However, if the disease becomes more advanced and spreads to other areas of your body it can become more difficult to treat.

Immunicom has joined the efforts of doctors and researchers to find new and better ways to treat non-small cell lung cancer. We presently have two clinical research studies being conducted, one in Israel and another in Turkey, that are actively recruiting patients diagnosed with advanced non-small cell lung cancer. Additional information about non-small cell lung cancer can be found at these websites:

Information About Immunicom’s Clinical Research Studies

If you or a loved one is interested in participating in one of our clinical research studies that is actively recruiting patients, you can learn more by reviewing the information presented below and clicking on the links that will provide more detailed information.

CP7 – 007

Conducted at Sheba Medical Center in Israel

CP7 – 008

Conducted at Acibadem Healthcare Group Hospitals in Turkey

ELIGIBILITY CRITERIA

  • At least 18 years old and diagnosed with non-small cell lung cancer
  • Have non-small cell lung cancer that is metastatic (has spread in the body)
  • Already have had at least one other treatment that did not stop the cancer from spreading or worsening

What is Renal Cell Carcinoma?

Renal Cell Carcinoma (also referred to as renal cell cancer or RCC) is the most common type of kidney cancer. There are many types of renal cell cancers and you may have more than one type at the same time.

The most common type of renal cell carcinoma is called ‘clear cell’ and is due to a genetic mutation. Other types are believed to be hereditary and may be passed along in families from one generation to another. The clear cell type has the most treatment options, while the rare, unclassified type, is difficult to treat. There is even a type that is benign (not a cancerous tumor) and does not spread.

Treatment depends on the type(s) of renal cell carcinoma you have. Sometimes, no treatment is recommended if it will not spread. However, the earlier the renal cell carcinoma is detected, the better chance you have of controlling or curing the disease. Many renal cell cancers often can be treated with surgery by removing part of or the entire affected kidney. In more advanced cases, if the disease has spread to other parts of your body, there are other treatments such as chemotherapy, targeted therapy and immunotherapy drugs, as well as combinations of these treatments.

Immunicom is committed to helping doctors and researchers find new treatments for renal cell carcinoma.

Additional information about renal cell carcinoma can be found at these websites:

Information About Immunicom’s Clinical Research Studies

If you or a loved one is interested in participating in one of our clinical research studies that is actively recruiting patients, you can learn more by reviewing the information presented below and clicking on the links that will provide more detailed information.

CP7 – 007

Conducted at Sheba Medical Center in Israel

ELIGIBILITY CRITERIA

  • At least 18 years old and diagnosed with renal cell carcinoma
  • Have renal cell carcinoma that is metastatic (has spread in the body)
  • Already have had at least one other treatment that did not stop the cancer from spreading or worsening

What is Melanoma?

Melanoma is primarily found on your skin and although is not a common type of skin cancer, it can be the most challenging to treat. In up to 10% of cases, Melanoma also can occur in your mouth or even your eye.

The number of cases of melanoma continues to increase worldwide and is increasing faster (and is the second most common type of cancer) in younger women. Melanoma is more common in women than men under the age of 50, but much more common in men in age groups more than 50 years old. Melanoma is far more common in individuals who are white than in people of color; however, it is often not diagnosed early in people of color.

If detected early, melanoma often can be cured by surgically removing the cancer from the skin. Once it has spread, it is more difficult to treat. However, many years of hard work by doctors and researchers are now producing new types of drugs called targeted therapies and immunotherapy agents, that attack melanoma in different ways and can greatly improve survival, even in advanced stages of the disease. Other treatments continue to be studied.

Immunicom is involved in finding new ways to treat melanoma. We have a clinical research study in Israel that is actively recruiting patients diagnosed with advanced melanoma.

Additional information about melanoma can be found at these websites:

Information About Immunicom’s Clinical Research Studies

If you or a loved one is interested in participating in one of our clinical research studies that is actively recruiting patients, you can learn more by reviewing the information presented below and clicking on the links that will provide more detailed information.

CP7 – 007

Conducted at Sheba Medical Center in Israel

ELIGIBILITY CRITERIA

  • At least 18 years old and diagnosed with melanoma
  • Have melanoma that is metastatic (has spread in the body)
  • Already have had at least one other treatment that did not stop the cancer from spreading or worsening

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