Some senior Indian scientists working on blood substitutes or artificial blood that could replace human blood in transfusions, say that a marketable product could become available in two or three years.
Dr Anil Gulati, president of Chicago Labs, USA told Pharmabiz.com in Hyderabad recently, that two American companies had filed applications with FDA for permission to market artificial blood.
His own company, in collaboration with the University of Illinois, has already completed animal studies and is looking for partners to proceed towards filing IND(investigational new drug) with FDA. He hopes to market their product within three years.
Tracing the history of research in artificial blood, Dr Gulati said in the 60's there was some breakthrough in the studies but the project was shelved because of renal failure in two patients. The US Army got interested in artificial blood following a research paper published by an Indian, S S Chatterjee. The Army, together with Baxter, took up the project called Alpha & Alpha based on cross-linked haemoglobin. Though the Army slowed down later, Baxter went ahead in a big way, completed pre-clinical studies and obtained permission to do clinical trials. That was in 1991. In the year 1999, the project failed at phase-III due to toxicity. The mortality rate was 23 % higher in artificial blood.
Dr Gulati said in the early researches it was found that when haemoglobin was injected into the body, the blood pressure and also the pulmonary artery pressure shot up. At the University of Illinois, the plan is to produce polymerized haemoglobin by using the surface conjugation technology. In this there was an in-built pressure neutralizing substance which controlled the pressure from going up.
Dr Gulati said the new substance would have only the oxygen-carrying properties and no nutrients and components. This would not require blood-typing or blood-matching. This would be a replacement for RBC and could be stored for at least one year.
Dr Gulati, an MBBS and MD from Lucknow, had obtained his PhD from Erasmus University, Rotterdam, Holland, and a Board Certificate in Chemical Pharmacology from the US. He began research in artificial blood in 1988, and was consultant to Baxter, Illinois, on their blood substitute programme and also consultant to Synzyme Technology, California, before joining the artificial blood programme of the University of Illinois.
Chicago Labs, a start-up company, with the university of Illinois, is developing a technology to enhance the pain-killing properties of morphine and other opiates and completely remove the development of tolerance to morphine or opiates. Studies have been successful on two different animal species. They were negotiating with a pharmaceutical company for its further development.
The company is also working on a technology to increase the delivery of cancer drugs to the tumour tissues in breast cancer. The animal studies are in progress. Research on strokes and enzyme diseases are at animal trial stage. Dr Gulati also teaches in the University of Illinois and is a guide for research students.