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Alnylam Pharmaceuticals, Inc. Message Board

  • watchoowant2000 watchoowant2000 Sep 20, 2005 9:19 AM Flag

    Dropping its AMD program

    Link at: http://biz.yahoo.com/bw/050920/205435.html?.v=1

    Alnylam Accelerates RSV Infection Program and Provides Update on AMD Program
    Tuesday September 20, 8:00 am ET
    Rapid Progress with RSV Program Supports IND Filing by Year End


    CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sept. 20, 2005--Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY - News), a leading RNAi therapeutics company, today updated its product pipeline guidance for the remainder of 2005. The company now expects to file an investigational new drug (IND) application for ALN-RSV01, its proprietary RNAi therapeutic candidate for RSV infection, with the Food and Drug Administration (FDA) by the end of the year, rather than in the first half of 2006 as previously forecast. In addition, given the reported efficacy in recent Phase III studies from competing drugs targeting vascular endothelial growth factor (VEGF) for the treatment of age-related macular degeneration (AMD), the company has made a strategic business decision to suspend further development of ALN-VEG01, its RNAi therapeutic candidate targeting VEGF for AMD, in order to allocate resources to other product opportunities.
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    "Our RSV program continues to generate compelling pre-clinical data, as was presented Sunday by Alnylam scientists at the RSV Symposium 2005," said John Maraganore, Ph.D., President and Chief Executive Officer of Alnylam Pharmaceuticals. "There exists a significant unmet medical need for novel therapies to effectively treat patients infected with RSV, and we are pleased to report that, based on the tremendous progress we have made with this proprietary program, we are able to move our therapeutic candidate into human clinic trials ahead of schedule. Based on our interactions with regulatory authorities we believe we have a clear path forward to conduct a Phase I safety study."

    "We have also made an important business decision to put the development of ALN-VEG01, part of our Merck ocular collaboration, on hold," continued Dr. Maraganore. "ALN-VEG01 had been expected to advance into Phase I clinical trials in the second half of 2005. With the increasingly competitive landscape for VEGF-targeting AMD therapeutics on the market and in late-stage human trials, we have made the strategic decision to allocate resources to higher-value product opportunities, such as ALN-RSV01. However, Alnylam and Merck continue to work together on the discovery of other RNAi therapeutics for the treatment of ocular disease."

    At the RSV Symposium 2005, held recently in the UK, Alnylam researchers reported that ALN-RSV01 selectively and potently silences the highly conserved RSV N gene, which encodes a previously non-druggable protein target required for viral replication. Data presented show both in vivo and in vitro efficacy in pre-clinical animal studies. Intranasally delivered ALN-RSV01 specifically inhibits RSV replication in animals and is active in the prevention and treatment of RSV infection. Additionally, Alnylam reported that the in-life phase of IND-enabling GLP toxicity studies of ALN-RSV01 has been completed with no significant toxicities seen to date. The abstract, titled "siRNA intervention strategies for Respiratory Syncytial Virus Infection" was awarded 'Best Abstract' of the symposium by committee organizers.

    The Company is reiterating its financial guidance that it will end the year with greater than $75 million in cash, and remains on track to announce its third development program by year-end.

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    • Should I take your two recent posts in the context of your "Liberalism is a mental disorder" diatribe?

    • "How far back?"

      The posts on AMD. The discussion was about whether ALNY's dropping their AMD project was a good idea because targeting AMD could be done locally, whereas their other targets are through systemic delivery, which is more difficult.

      "What does intranasal have to do with pulmonary?"

      Where does air go when you breathe through your nose?

      "Who is attempting to aerodolize nucleic acids?"

      Inhibition of respiratory syncytial virus infection with intranasal siRNA nanoparticles targeting the viral NS1 gene.

      Zhang W, Yang H, Kong X, Mohapatra S, San Juan-Vergara H, Hellermann G, Behera S, Singam R, Lockey RF, Mohapatra SS.

      Nat Med. 2005 Jan;11(1):56-62. Epub 2004 Dec 26

      To name one.

    • How far back?

      >>Wasn't familiar with the company, but I checked out their website. . .Nasal delivery is an interesting approach, and may work for RSV or other lung specific diseases. But I'd like to see some real data. Not to be a naysayer, but I'm always wary about claims of "70% reduction by QPCR", which is how these studies are generally reported. 70% of untreated can still mean plenty of gene product. Plus nucleic acids have a lot of charge that needs to be neutralized to aerosolize them, and presumably keep them stable. This is complex chemistry. Interesting company though. Thanks. <<

      What does intranasal have to do with pulmonary?

      Who is attempting to aerodolize nucleic acids?

    • I'm neither confused nor off-base; read further back.

    • You are confused and off base. The first RNAi candidate is an injectible NOT IN. It is a systemic for RA and targets the production of TNF-a.

    • coroners_assistants_helper coroners_assistants_helper Sep 21, 2005 7:20 PM Flag

      <NSTK has an excellant message board.>
      Yeah - sort of. Participate only if you agree 100% that NSTK is future DNA, and Quay is the greatest leader since Abe Lincoln, or else. One of the most cultish boards on the whole Yahoo.

    • AK41 : NSTK is tied in with ALNY some how. That's why I lokk at ALNY.
      NSTK has an excellant message board.
      Your welcome
      Lou

    • Wasn't familiar with the company, but I checked out their website. . .Nasal delivery is an interesting approach, and may work for RSV or other lung specific diseases. But I'd like to see some real data. Not to be a naysayer, but I'm always wary about claims of "70% reduction by QPCR", which is how these studies are generally reported. 70% of untreated can still mean plenty of gene product. Plus nucleic acids have a lot of charge that needs to be neutralized to aerosolize them, and presumably keep them stable. This is complex chemistry. Interesting company though. Thanks.

    • Not surprising really. The have always been looking to target areas where there is no other suitable treatments. They've dropped the ball with AMD so they are moving on.

 
ALNY
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