Tuesday, September 16, 2008

 

Human clinical trials of IN-105

India's Biocon Ltd., a biotechnology company, and its subsidiaries Syngene and Clinigene focus on biopharmaceuticals, contract research and clinical research. India's first indigenous monoclonal antibody was produced by Biocon in September 2006 BIOMAb-EGFR(TM) a new cancer drug for the head and neck. Biocon also launched the world's first recombinant human insulin, INSUGEN(R) in November 2004.

Biocon's IN-105 is another more novel insulin product, research into which began with the collaboration between Biocon and the US-based Nobex Corporation in 2004. Later when Nobex filed for bankruptcy, all its patents (intellectual property) were bought by Biocon. The great advantage of IN-105 is that it can be taken orally without the use of needles. The tablet releases insulin in practically the same manner as the human pancreas. Early this month Biocon announced the results of human trials of IN-105 at the European Association for the Study of Diabetes (EASD) meeting in Rome (September 8, 2008).

human clinical trials

The study involved dosing Type 2 diabetes subjects with single doses of 0 mg (placebo), 10 mg, 15 mg, 20 mg and 30 mg tablets of IN-105 in 5 separate periods before a mixed 600 kcal breakfast. The outcome measurements were the safety and tolerability of IN-105, as well as the pharmacokinetics and pharmacodynamics of IN-105. The results showed that IN-105 was safe and well tolerated by patients.

Due to the rapid pharamacokinetics of the drug, there were transient values of hypoglycemia seen soon after the administration of the drug; however these values did not result in any symptoms due to the rapid alleviation of glucose levels due to the meal that followed the drug. C-peptide values were also significantly depressed over all the doses tested, indicating a possibility of beta cell rest in patients dosed with IN-105.


"The data presented here show that insulin can be reliably delivered in individuals with type 2 diabetes via the oral route. Further the administered insulin improved control post meal plasma glucose without causing symptomatic hypoglycemia. Such data support the feasibility of oral insulin delivery as a therapeutic option," said Prof Alan D. Cherrington, Ph.D. Professor of Molecular Physiology & Biophysics, Professor of Medicine, Vanderbilt University.

Longer term, 6 month, studies are being planned in Type 2 diabetic subjects to understand the impact of chronic dosing of IN-105 on postprandial glucose control and glycated haemoglobin.



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