FDA Approves Investigational New Drug Application For an Experimental Treatment for Guillain-Barre Syndrome

According to a story from BioSpace, the biotechnology company Cellenkos, Inc., recently announced that the US Food and Drug Administration (FDA) has given the company the go ahead to begin its Phase I trial of its investigational product CK0801. This product is in development as a treatment for Guillain-Barré syndrome that is resistant to other treatments.

About Guillain Barré Syndrome

Guillain-Barré syndrome is an autoimmune disease which is characterized by rapid onset muscle weakness. This is caused by the immune system inflicting damage on the peripheral nervous system. The symptoms can appear in a little as a few hours or over the course of a few weeks. The trigger the causes the autoimmune response is linked to an infection of the digestive tract or respiratory tract in most cases. The infections are often linked to Campylobacter jejuni or cytomegalovirus. Other infections can also serve as potential triggers. Symptoms of Guillain-Barré syndrome include sensations like numbness, pain, or tingling, progressive muscle weakness of the arms, legs, and face, pain, and difficulty swallowing. Some patients may experience respiratory failure, which is a medical emergency. Treatment includes interventions to restore breathing ability, immunotherapy, and rehabilitation to restore movement and muscle strength. To learn more about Guillain-Barré syndrome, click here.

About CK0801

CK0801 is an innovative first in class drug. This drug is intended to regulate the activity of T-cells, the immune cells that are often involved in autoimmune disease. The therapy allows healthy T-cells to converge at the points where inflammatory activity is occurring, which served to shut down the autoimmune response and restore normal immune system activity. In effect, the therapy is able to replace the cells that are causing the inflammation.

The exact structure for the Phase I trial has yet to be determined. However, Cellenkos will be working with the University of Texas Health Sciences Center for the trial, which will be led by Dr. Kazim Sheikh.

About Cellenkos

The current development focus of Cellenkos on T regulatory cell treatments that are derived from cord blood, which is blood that is obtained from the umbilical cord. These treatments are intended to address inflammatory disorders and autoimmune diseases such as Guillain-Barré syndrome.

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