India biotechnology company claims to have a cure for H1N1 swine flu made from plant extracts
Thursday, August 27, 2009
India biotechnology company claims to have a cure for H1N1 swine flu made from plant extracts
New Delhi : India based biotechnology company claims to have a cure for H1N1 swine flu.According to Indus biotechnology its compound is effective in Tamiflu-sensitive (strain 676) as well as Tamiflu-resistant (strain 6706) swine flu.
The new antiviral, which is derived from a plant in the human food chain and hence is very low on toxicity, a burden that most synthetic drugs come with.
While Indus has filed an investigational new drug (IND) application with the US Food and Drug Administration (FDA) for the compound’s action against HIV, subsequent research at one of the laboratories it works with at the National Taiwan University Hospital in Taipei showed that the compound is very effective against another virus—H1N1.
While testing a compound on asthma, and studying the link between inflammation and autoimmune diseases, Indus came across an interesting mechanism that triggers inflammation. “We were curious and tested our compound on HIV virus two years ago in a high safety lab in Taipei and we found it confirmed our hypothesis.
The company now proposes to develop this drug for influenza and H1N1, both as a drug as well as a prophylactic since it shows promise in preventing the infection.
The Indus team will present the data to the Union health ministry next week and seek an approval road map as India, unlike the US, doesn’t have guidelines for botanical drugs—drugs that are made from plant extracts. “Our science is impeccable and we are open to scrutiny from any agency,”.
After completing its patent filing on 11 August, Indus submitted its H1N1 data to the health ministries of Cambodia and the Philippines, which are currently evaluating it for placing supply orders. Experts say H1N1, like other influenza viruses, mutates fast, so attacking it with just one drug—as is the case today—is not a good strategy. “Combination therapy, as is seen in HIV, is always advisable in fights against virus. That’s why you see that countries that use flu shots for the seasonal virus, develop it every year, depending on the virulent strain.
One of the challenges before the drug discovery companies that do bioprospecting is their inability to produce a standardized product, says Rajan R. Srinivasan, executive director of Indus. In the absence of such a process, called chemistry and manufacturing control by FDA, plant-derived products remain in the nutritional category and never reach the prescription drug level.
Indus has a calculated strategy:
The starting point, always, is food chain raw materials with well-known medicinal value, so that toxicity risk is minimal. It conducts proof of concept studies in humans at a very early stage, even though they are not mandatory in standard IND application. “By design, we have orphan positioning for most drug candidates with respect to the US FDA, which allows for shorter approval time with smaller studies,” says Srinivasan. An orphan drug, according to FDA, is one that addresses a disease affecting less than 200,000 people in the US and hence, isn’t of interest to most pharmaceutical firms.
“That’s why we are filing INDs in the US and we’ll take these molecules to their logical conclusion in the US,” he added.
New Delhi : India based biotechnology company claims to have a cure for H1N1 swine flu.According to Indus biotechnology its compound is effective in Tamiflu-sensitive (strain 676) as well as Tamiflu-resistant (strain 6706) swine flu.
The new antiviral, which is derived from a plant in the human food chain and hence is very low on toxicity, a burden that most synthetic drugs come with.
While Indus has filed an investigational new drug (IND) application with the US Food and Drug Administration (FDA) for the compound’s action against HIV, subsequent research at one of the laboratories it works with at the National Taiwan University Hospital in Taipei showed that the compound is very effective against another virus—H1N1.
While testing a compound on asthma, and studying the link between inflammation and autoimmune diseases, Indus came across an interesting mechanism that triggers inflammation. “We were curious and tested our compound on HIV virus two years ago in a high safety lab in Taipei and we found it confirmed our hypothesis.
The company now proposes to develop this drug for influenza and H1N1, both as a drug as well as a prophylactic since it shows promise in preventing the infection.
The Indus team will present the data to the Union health ministry next week and seek an approval road map as India, unlike the US, doesn’t have guidelines for botanical drugs—drugs that are made from plant extracts. “Our science is impeccable and we are open to scrutiny from any agency,”.
After completing its patent filing on 11 August, Indus submitted its H1N1 data to the health ministries of Cambodia and the Philippines, which are currently evaluating it for placing supply orders. Experts say H1N1, like other influenza viruses, mutates fast, so attacking it with just one drug—as is the case today—is not a good strategy. “Combination therapy, as is seen in HIV, is always advisable in fights against virus. That’s why you see that countries that use flu shots for the seasonal virus, develop it every year, depending on the virulent strain.
One of the challenges before the drug discovery companies that do bioprospecting is their inability to produce a standardized product, says Rajan R. Srinivasan, executive director of Indus. In the absence of such a process, called chemistry and manufacturing control by FDA, plant-derived products remain in the nutritional category and never reach the prescription drug level.
Indus has a calculated strategy:
The starting point, always, is food chain raw materials with well-known medicinal value, so that toxicity risk is minimal. It conducts proof of concept studies in humans at a very early stage, even though they are not mandatory in standard IND application. “By design, we have orphan positioning for most drug candidates with respect to the US FDA, which allows for shorter approval time with smaller studies,” says Srinivasan. An orphan drug, according to FDA, is one that addresses a disease affecting less than 200,000 people in the US and hence, isn’t of interest to most pharmaceutical firms.
“That’s why we are filing INDs in the US and we’ll take these molecules to their logical conclusion in the US,” he added.
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