Indus Biotech's drug shows promise in HIV, H1N1
Biospectrum – December 1, 2009
Ajeesh Anand
Bangalore, Dec 01, 2009: What could be a major breakthrough in the fight against AIDS, Indus Biotech, a Pune, India-based drug discovery company, has come up with a botanical drug candidate, which has shown efficacy in HIV/AIDS patients.
The company claims that this antiviral drug candidate has also shown promising results for the pandemic H1N1 during initial clinical trials. Apart from taming HIV/AIDS, according to the founders of the company Mr Sunil Bhaskaran and Mr Rajan Srinivasan, the company is developing this molecule as an influenza A drug, which has shown efficacy in various influenza A strains such as H1N1, H5N1 and H3N2.
The company has received an Investigational New Drug (IND) application approval from the US Food and Drug Administration (FDA) for this novel drug candidate, IND02. With this approval, Indus Biotech has become the first Indian drug discovery company to have obtained IND approval from FDA to start human clinical trials for this drug in the US. Furthermore, the company has also made an IND submission with the Drug Controller General of India (DCGI), the FDA equivalent of the country, and is awaiting clearance to start a large-scale study locally.
The company expects that post approval, the clinical studies for H1N1 would take five to seven months, while for HIV it would take 18 to 24 months.
Highlighting the mechanism of action of IND02, Mr Bhaskaran said, “In simple terms, this drug converts an HIV patient into what is called in scientific circles as an 'HIV controller' and people can well live out their normal life span with the disease, without the concerns of the high cost of treatment or the dramatic shortening of their life span. IND02 is an 'enabler' that converts the HIV patient to a HIV controller.”
According to the company, since it is a botanical drug, it has got huge advantages over the New Chemical Entity (NCE) drugs and the biologicals. The company terms this drug as 'the third world answer for third world diseases'. This botanical drug would be affordable with less side-effects as compared to the anti-retroviral therapy (ART), the current first-line therapy for AIDS. The company estimates that the drug would cost only a fraction of ARTs.
“However it is difficult to comment on the cost now, which would be decided by the marketing partner to who we out-license the drug. Once the drug is ready to be commercialized, we would start discussions with companies strong in antivirals and anti-infectives,” says Mr Srinivasan.
http://www.biospectrumasia.com/Content/011209IND11412.asp?nl=4_18224_Dec1
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