ALNY takes aim at Medimmune and its bread and butter, Synagis. By the time they get anywhere with this, they'll likely be facing 2nd generation Synagis produced by Applied Molecular Evolution and devolped by MEDI, called Numax.
>>CAMBRIDGE, Mass., Jan. 4 /PRNewswire-FirstCall/ -- Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY - News), a leading RNAi therapeutics company, today announced it has initiated a therapeutic development program for the treatment of respiratory syncytial virus (RSV) infection. RSV is a major cause of respiratory illness in young children, the elderly and immune- deficient patient populations. RSV infects nearly every child by the age of two years and typically results in cold-like symptoms; however, it may lead to lower respiratory tract infections or respiratory failure. Children born prematurely or with pulmonary, cardiac and immune deficiencies are at the highest risk for severe RSV infection that can result in hospitalization, morbidity and even death. Alnylam will implement its Direct RNAi(TM) technology to treat RSV infection by targeting key viral genes at the site of infection.
"We are excited to initiate this new program in RSV disease, as it further advances our leadership in the development of Direct RNAi therapeutics for important diseases with unmet medical needs," said John Maraganore, President and Chief Executive Officer of Alnylam Pharmaceuticals. "We plan to move forward aggressively to develop a novel treatment for RSV infection, present additional in vivo data at upcoming scientific meetings and initiate clinical trials in the first half of 2006."
This program is based in part on research published last week in Nature Medicine by Professor Sailen Barik and his colleagues from the University of South Alabama, College of Medicine. This research demonstrated that RSV infection could be prevented and treated with high potency in an animal model by intranasal administration of short interfering RNAs (siRNAs), the molecules that induce RNAi.
"Our published results showing in vivo inhibition of RSV through intranasal delivery of siRNAs clearly highlight the power of harnessing the natural process of RNAi," said Sailen Barik, Ph.D., Professor in the Department of Biochemistry at the University of South Alabama, College of Medicine. "We are excited to be working with Alnylam Pharmaceuticals, the leading RNAi therapeutics company, as we believe they are best able to rapidly advance our scientific breakthrough to positively impact the significant RSV patient population worldwide."
The RSV therapeutic program is the second therapeutic development program announced by Alnylam, the first being the age-related macular degeneration program Alnylam is conducting in collaboration with Merck. Both programs aim to develop Direct RNAi products, which are RNAi therapeutics that will be administered directly at sites of diseases, such as the lung, eye or the brain. In addition, Alnylam has a number of earlier-stage pre-clinical programs including a program in Parkinson's disease and additional programs as part of its collaborations with Merck.
In connection with its new RSV program, Alnylam has completed a licensing agreement with the University of South Alabama that provides Alnylam with an exclusive license to certain intellectual property stemming from the work of Dr. Sailen Barik. The license covers RNAi compositions and methods of treating pulmonary viral infections with siRNAs.
About RSV
RSV is a highly contagious virus that causes infections in both the upper and lower respiratory tract. RSV infects nearly every child by the age of two years and is a major cause of hospitalization due to respiratory infection in infants born prematurely, children with lung or congenital heart disease, the elderly, and other adult immune-compromised populations. RSV infection typically results in cold-like symptoms but can lead to more serious respiratory illness such as croup, pneumonia and bronchiolitis, and in extreme cases severe morbidity and death. RSV is responsible for up to an estimated 125,000 pediatric hospitalizations each year in the United States. As a result, there is a significant need for novel therapeutics to treat patients who become infected with RSV.<<
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>>Nat Med. 2004 Dec 26; [Epub ahead of print]
Inhibition of respiratory viruses by nasally administered siRNA.
Bitko V, Musiyenko A, Shulyayeva O, Barik S.
Department of Biochemistry and Molecular Biology (MSB 2370), University of South Alabama, College of Medicine, 307 University Boulevard, Mobile, Alabama 36688-0002, USA.
Respiratory syncytial virus (RSV) and parainfluenza virus (PIV) are two respiratory pathogens of paramount medical significance that exert high mortality. At present, there is no reliable vaccine or antiviral drug against either virus. Using an RNA interference (RNAi) approach, we show that individual as well as joint infection by RSV and PIV can be specifically prevented and inhibited by short interfering RNAs (siRNAs), instilled intranasally in the mouse, with or without transfection reagents. The degree of protection matched the antiviral activity of the siRNA in cell culture, allowing an avenue for quick screening of an efficacious siRNA. When targeting both viruses in a joint infection, excess of one siRNA moderated the inhibitory effect of the other, suggesting competition for the RNAi machinery. Our results suggest that, if properly designed, low dosages of inhaled siRNA might offer a fast, potent and easily administrable antiviral regimen against respiratory viral diseases in humans.<<
Cheers, Tuck |
