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Novartis’ dengue drug to undergo human studies

Wednesday, March 25, 2009, 12:48 This news item was posted in Clinical Trials category and has 0 Comments so far.

 

A drug to cure the dreaded dengue fever will be ready to test in humans in next two years. Dengue fever, which affects millions of people in the poor countries has no known cure yet.

Novartis, the Swiss drug MNC, has lined up a few new potential drug candidates to treat dengue fever. Atleast one of them is expected to undergo human studies by the year 2011. 

novartis

Human studies — also called clinical trials to study if the drug has any bad effect on healthy as well as diseased people –are the last phase of the development process before the dengue drug reaches the chemist shops.

Dengue is a serious infectious disease spread by mosquitoes. It is caused by a virus belonging to the class of flavivirus. The major symptoms of dengue infection are fever, severe joint pain and, in some cases, hemorrhage, shock and death. Dengue hemorrhagic fever (DHF), an advanced form of dengue, can kill 20 percent of the people it infects, making the disease a key public health concern.

Four types of closely related viruses cause dengue. This makes it difficult for researchers to develop an effective vaccine or treatment. Meanwhile, an estimated 500 000 cases require hospitalization each year. A large number of these are children.

Dengue affects 50 million people annually, of which half a million are hospitalized and 12,500 die, according to the World Health Organization. Dengue, being a disease affecting mostly the people in the developing world, has no drug to cure or avaccine to prevent. Dengue patients are currently given only supportive treatment– some treatment to control the symptoms. 

Dengue has been largely neglected by big pharma companies in the US and Europe who discover new drugs for diseases. Because, most of the drug makers find developing drugs for diseases like dengue is the least profitables. And no drug company from the so-called 3rd world- including India–has successfully deveoped a new drug to treat an illness todate.

In a big departure, the Novartis Institute for Tropical Diseases (NITD) has been working on a drug to treat for dengue since 2002. NITD is a partnership between Novartis and the Singapore government incepted to develop drugs to treat diseases affecting the poor, tropical countries, is also working on treatments for malaria and tuberculosis. 

Novartis intially had plans to to launch the dengue drug studies last year. However, laboratory tests on Novartis’s most advanced potential cure for dengue were discontinued in October because of concerns about its safety for humans, Paul Herrling, head of corporate research at Novartis, said in an interview. 

Getting laboratory studies under way has taken time, largely because most global experts on tropical diseases were academics with little experience in the pharmaceutical industry, Mr. Herrling said. NITD now has 100 Singaporean and foreign scientists.”There was no drug discovery [in tropical diseases], so we had to hire academics,” Mr.Herrling said.

Novartis is now developing other potential dengue cures that are likely to take two years to bring to clinical trials, he added.

Novartis’ dengue drug portfolio

Novartis’s drug portfolio against dengue consists of viral targets such as NS5 RNA-dependent RNA polymerase, nucleoside inhibitor, prodrug of nucleoside inhibitor, non-nucleoside inhibitor, NS5 methyltransferase and host target cholesterol biosynthesis.  

Its high throughput screening for anti-dengue activity in cell-based assays has been completed and is being followed by target deconvolution and lead identification. Novartis is also developing therapeutic antibodies in association with Experimental Therapeutics Centre and National University Singapore.

Dengue cases are on the rise worldover, in recent decades. Dengue is classified as a re-emerging infectious disease. Dengue and dengue hemorrhagic fever/ dengue shock syndrome (DSS) occur in more than 100 countries, with more than 2.5 billion people at risk and an estimated 50 to 100 million infections per year. The major disease burden is found in Southeast Asia and the Western Pacific, with increased reporting of dengue in the Americas.

2006 Dengue fever in India

Dengue fever is a growing concern in India also. In 2006 there was a dengue outbreak in India. Cases of dengue fever were reported first from New Delhi in early September and by end of September other states in India also started to report deaths due to dengue fever of the year.

 

State      Cases Reported

New Delhi       886

Kerala               713

Gujarat            424

Rajasthan       326

West Bengal   314

Tamil Nadu    306

Maharastra     226

Uttar Pradesh     79

Harayana        65

Karnataka        59

Andhra Pradesh      9

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