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Bioxytran gets CDSCO approval to initiate trials with ProLectin-I to treat Long Covid and idiopathic pulmonary fibrosis

Boston, Massachusetts
Tuesday, February 7, 2023, 15:00 Hrs  [IST]

Bioxytran, Inc., a clinical stage biotechnology company, announced the receipt of an Investigational New Drug (IND) authorization letter from India’s Central Drugs Standard Control Organization(CDSCO) to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ProLectin-I injection. The objective of this trial is to provide guidance for our future phase II trial in Long Covid and idiopathic pulmonary fibrosis (IPF).  This is a separate and additional approval from the authorization that ProLectin-M received on December 2, 2022.  

ProLectin-I is an intravenous new chemical entity drug that is expected to treat Long Covid and idiopathic pulmonary fibrosis. Long Covid is estimated to have 65 – 100 million cases worldwide.  The CDC believes it affects one in five people that contract Covid-19.  According to Harvard University, the economic cost of Long Covid is $3.7 trillion in the just the United States. IPF affects approximately 3 million people worldwide. The disease primarily affects patients over the age of 50 and affects more men than women.

The top theory behind the pathogenesis of Long Covid is viral persistence6 or viral fragments. ProLectin-I binds to the ‘galectin fold’ of the spike protein thereby neutralizing a replication competent viruses’ ability to infect other cells, but it also binds to spike protein fragments thought to be the cause of ongoing inflammation.

The medical term for scar tissue is fibrin. The word fibrosis stems from the continued growth of fibrin. Once scar tissue forms in the lungs combined with an already suppressed immune system, scar tissue can start to spread quickly. The reason for scar tissue forming in the lungs can vary, but it can always be associated with the onset of lung damage. Combining lung damage with an impaired immune system leads to scar tissue forming in the lungs. Multiple galectin types are associated with fibrosis, and ProLectin-I is thought to bind to a few.

Bioxytran, Inc. is a clinical stage biotechnology company developing novel therapies targeting the treatment of significant unmet medical needs in virology, degenerative disease, and hypoxia.


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