Indus Biotech gets FDA nod to start trials for HIV/AIDS molecule

[marius68]

Another company to start clinical trials! Interestingly they want to start a phase III trial in India. No numbers of VL, CD4s, etc are given

You can read here:

http://www.biospectrumasia.com/Content/291009IND11100.asp

http://www.indusbiotech.com/about/aboutus.asp


Bangalore. Oct 29, 2009: India-based Indus Biotech, focusing on drugs derived from plant extracts, announced the scientific breakthrough of their HIV/AIDS drug IND02. The molecule has recently obtained an IND approval from the FDA and is now all set to commence with human clinical trials in US. The company also announced that it has applied for an IND approval to the Drug Controller General of India (DCGI). If approved Indus Biotech would be the first company in India to get an IND approval for a botanical drug. Indus Biotech is an Intellectual Property Driven company and has 10 granted International Patents and another 22 international patents that are applied for and are in the process of being granted.

Highlighting the mechanism of action of IND02, their drug candidate, Mr Sunil Bhaskaran, the MD of Indus Biotech, 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 their normal life span with the disease, without the concerns of the high cost of treatment or the dramatic shortening of their life span." He further went on to say that 1 in 300 HIV patients is a "Natural HIV Controller", who is able to block the progression of the disease by managing the virus and protecting the immune cells. IND02 is drug candidate that is an "enabler" that converts the HIV patient to a HIV Controller.

Interestingly, the molecule has also shown new indications for the H1N1 strain as well as the H3N2 strain (avian flu). Also, it has shown to be effective on Tamiflu resistant strains. “Since both are anti viral strains we were curious to see whether the HIV molecule could also be a cure for the H1N1 strain and hence started with our studies in that area,” added Mr Bhaskaran. Separate studies will be conducted for the H1N1 strain and 330 patients would be recruited for clinical trails. “We have independently verified the studies in Japan and bio safety tests were conducted in the National Taiwan University Hospital in a P3P4 lab,” said Bhaskaran.

Now having received approval from the FDA, it will now move to phase I trials in the US and if approved by the DCGI will move to phase III trails in India. Around 40 patients were recruited for the pre clinical trials in Pune. “In India, there will be a one year study for this drug and we will take in 430 people while in the US we are negotiating for 32 people,” said Mr Rajan Srinivasan, executive director of the company.

Mr Srinivasan said, “All these years we were focusing on the US because India does not have clear guidelines for botanical drugs whereas the FDA in 2004, came up with concrete guidelines for botanical drugs. Botanical drugs are prescription drugs and are not herbal nor are they alternative drugs. We extract drugs from food chain raw materials, identify the target and then commence with the drug discovery process. In this case toxicology levels are low, costs for a pre clinical studies are around $ 5-10 million and in case of a failure, the loss involved is also low.” With the guidelines out, in the US alone, there are around 200 IND submissions for botanical drugs to the FDA today.

Since the company is aiming at providing affordable drugs for neglected diseases for third world countries, officials did not deny the prospect of approaching organizations like the Bill and Melinda Gates Foundation who in turn would provide the drugs at a subsidized price.

Indus Biotech at present has 7 NCEs in the the pipeline with HIV/H1N1 (phase III) being the lead molecule. Other include diabetes (completed proof of concept studies and ready for phase III), rheumatoid arthritis (completed toxicology and Proof of concept), Parkinson's (will move into human trials in another 6 months recruiting 80 patients), Huntington's disease (pre clinical), Kidney disease and depression. The company is also looking at other segments such as dengue and Hepatitis 3.

[Inchlingblue]

I wish there was more information about this, it sounds very fishy. They say they received pre-IND approval from the FDA. They are claiming that the "botanical" drug can turn everyone into a "controller.'' They also say it works on Influenza and on H1N1. Sounds too good to be true.

Here is a description of how it came about:

During tests on a compound for asthma, studying the link between inflammation and autoimmune diseases, a mechanism triggering inflammation was noticed. Curious, its researchers tested the compound on the HIV virus two years ago. The influenza virus and H1N1 were tested after this. Each time, the compound was effective, not only in the Tamiflu-sensitive strain (676) but in the Tamiflu-resistant strain (6706).

I guess it's efficacy or lack thereof will be known if everyone who has HIV in India and takes this all of a sudden becomes an elite controller (DCGI is the FDA equivalent in India), since it might be available there sooner than elsewhere:

The drug could be available in India within a few months of it receiving the approval from DCGI for human trials.

LINK:

http://www.punjabnewsline.com/content/view/19897/93/