Skip to main content

Sanofi Pasteurs dengue vaccine in ph III clinical trials

News item: Source BioSpectrum, Asia Edition




Singapore, Nov 4, 2010: Sanofi Pasteur, the vaccines division of Sanofi-aventis Group, has announced that its dengue vaccine is in final stage of clinical development. Sanofi Pasteur’s dengue vaccine, the world’s most clinically advanced dengue vaccine candidate entered its first phase III clinical study in Australia. 

This study is part of a global phase III clinical study program aimed at advancing the development of a novel vaccine for the prevention of dengue disease in children and adults. Currently, there is no specific treatment available for dengue fever, which is a threat to nearly three billion people and a public health priority in many countries of Latin America and Asia where epidemics occur. 

Phase III studies are the ultimate steps in the clinical development of a vaccine before it is submitted to regulatory authorities for evaluation for market authorization. Sanofi Pasteur’s candidate dengue vaccine is the first to reach phase III of clinical development.

“To address the global health challenge represented by dengue fever, we are conducting an unprecedented dengue vaccine research and development program as well as a scale up of the vaccine production. We are now entering the final laps of a long run that Sanofi Pasteur started almost 20 years ago. If successful, we are committed to introducing the vaccine in countries where dengue is of highest public health priority,” said Mr Wayne Pisano, President and Chief Executive Officer of Sanofi Pasteur. 

The study in Australia is the first to use dengue vaccine doses produced with industrial scale processes. The study is aimed at demonstrating that production of the vaccine at industrial scale will meet consistency criteria required for market authorization by regulatory authorities. Details of the phase III study in Australia as well as results of already completed studies are presented at the 59th annual conference of ASTMH (American Society of Tropical Medicine and Hygiene), held in Atlanta, US, on November 3-7, 2010.

Comments

Popular posts from this blog

''Dynamic Indian of the millenium"

As Member Secretary of CLINICOM, I am so thrilled to post this information here:
''Dynamic Indian of the millenium" award conferred

Coimbatore, Jul 4 (PTI) City-based K G Foundation today conferred the 'Dynamic Indian of the Millennium' award on Arun Madhavan, a former member of Prime Minister's special committee for model village development programme under the 20-point programme.


The award, carrying a citation, was given for his 'distinguished achievements and contribution to society over the years', the foundation chairman G Bhakthavatsalam, said at a function got up as part of the celebrations of World Doctors' Day, here.

Besides being conferred a global recognition for his 'project gateway' for promoting India as an investment destination, Arun had delivered a speech at the United Nationas, Geneva, on 'A New dimension to healthcare,' in 1996, he said. The first recipient of this award was the former president, A P J Abdul K…

Isotretinoin in India: A tragedy in the offing

Isotretinoin in India: A tragedy in the offing
Wednesday, March 28, 2007 08:00 IST 
Seema Thakral

Isotretinoin is the drug of choice for severe calcitrant cystic acne vulgaris, which often causes scarring and depression from disfigurement. Isotretinoin has been called "the greatest medical advance of the 1980's." A majority of patients with acne are permanently cleared after a four to five months course of treatment. It has also been used off-label for a variety of oncology uses including: cervical cancer, head and neck cancer, squamous cell cancer of the skin, juvenile chronic myelogenous leukemia (CML), and neuroblastoma. However, the drug is a proved teratogen and carries a significant risk of birth defects, if it taken during pregnancy. Birth defects, which have been documented following isotretinoin exposure include abnormalities of the face, eyes, ears, skull, central nervous system, cardiovascular system, and thymus and parathyroid glands. There is an increased risk …

An important discovery

"Gene therapy strategies will come in with a major cost advantage since DNA interference technology will act at the DNA level at lower doses, reduce toxicity and only one or two copies of the DNA"- Dr Ramanand Nadig
President Operations and  
Deputy Dean 
Clinical Research Education and Management Academy (CREMA)
Genes are segments of DNA present in the chromosomes in the nucleus of every cell. Genes carry instructions for making proteins, which are then copied by special enzymes into many copies of messenger RNA (mRNA). The mRNA then comes out of the nucleus, into the body of the cell; where it goes on to create the proteins needed for everyday life. Faulty or mutated genes lead to malfunctioning proteins that cause disease. Gene expression can be blocked by restricting the ability of chromosomal DNA to be copied into RNA and made into proteins. This research has given the lead wherein the ways to correct genetic disease by changing mutant gene sequences to its normal has been …