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Fw: NATAP: New HCV Drug CPG 10101-FDA Fast Tracks

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  • Alley Pat
    NATAP http://natap.org/ ... Fast Track Designation from U.S. Food and Drug Administration Press announcement from Coley. WELLESLEY, Mass., May 17
    Message 1 of 7 , May 20, 2006
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      NATAP http://natap.org/
      _______________________________________________



      --------------------------------------------------------------------------------


      Fast Track Designation from U.S. Food and Drug Administration

      Press announcement from Coley.

      WELLESLEY, Mass., May 17 /PRNewswire-FirstCall/ -- Coley Pharmaceutical Group, Inc. (Nasdaq: COLY) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ACTILON (CPG 10101) for use in treatment-refractory patients chronically infected with the Hepatitis C virus (HCV).

      The Fast Track program of the Food and Drug Administration is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.

      "A Fast Track designation for our ACTILON development program allows Coley to work closely and expeditiously with the FDA to potentially benefit patients who currently have no other treatment alternatives," said Ferdinand E. Massari, M.D., Senior Vice President, Drug Development and Chief Medical Officer of Coley Pharmaceutical Group.

      ACTILON Clinical Development Status
      ACTILON is an investigational Toll-like receptor 9 (TLR9) agonist designed to induce both rapid and sustained immune responses that can have durable anti-viral effects.

      Positive data from the company's 12-week Phase Ib clinical study of ACTILON in combination with pegylated interferon and ribavirin among treatment-refractory patients, who had initially responded but then relapsed after treatment with pegylated interferon and ribavirin, were presented in April 2006 at the European Association for the Study of the Liver (EASL) meeting in Vienna, Austria.

      A 48-week Phase II clinical study evaluating safety and activity of ACTILON in combination with pegylated interferon and ribavirin is currently enrolling treatment-refractory HCV patients who never responded after a minimum of 12 weeks of pegylated interferon and ribavirin treatment.

      Here are links to the study results reported at EASL:
      EASL: Early Viral Response to New HCV Drug CPG 10101 Toll-Receptor Antagonist, in Combination with Pegylated Interferon and/or Ribavirin, in Chronic HCV Genotype 1 Infected Patients with Prior Relapse Response - (05/09/06)

      EASL: Randomized, Placebo-Controlled, Dose-Escalation Trial of New HCV Drug CPG 10101 Toll-Receptor Antagonist in Patients with Chronic Hepatitis C Virus - (05/09/06)


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    • avansi7465
      Now that s some good news! Let s keep our fingers crossed. How goes it, kiddo? Anne
      Message 2 of 7 , May 21, 2006
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        Now that's some good news! Let's keep our fingers crossed. How goes it, kiddo? Anne

        -----Original Message-----
        >From: Alley Pat <alleypat@...>
        >Sent: May 20, 2006 3:27 PM
        >To: happyheppers <happyheppers@yahoogroups.com>, GIWorld-Hepatitis@yahoogroups.com
        >Subject: [GIWorld-Hepatitis] Fw: NATAP: New HCV Drug CPG 10101-FDA Fast Tracks
        >
        >
        >
        >NATAP http://natap.org/
        >_______________________________________________
        >
        >
        >
        >--------------------------------------------------------------------------------
        >
        >
        >Fast Track Designation from U.S. Food and Drug Administration
        >
        >Press announcement from Coley.
        >
        >WELLESLEY, Mass., May 17 /PRNewswire-FirstCall/ -- Coley Pharmaceutical Group, Inc. (Nasdaq: COLY) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ACTILON (CPG 10101) for use in treatment-refractory patients chronically infected with the Hepatitis C virus (HCV).
        >
        >The Fast Track program of the Food and Drug Administration is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.
        >
        >"A Fast Track designation for our ACTILON development program allows Coley to work closely and expeditiously with the FDA to potentially benefit patients who currently have no other treatment alternatives," said Ferdinand E. Massari, M.D., Senior Vice President, Drug Development and Chief Medical Officer of Coley Pharmaceutical Group.
        >
        >ACTILON Clinical Development Status
        >ACTILON is an investigational Toll-like receptor 9 (TLR9) agonist designed to induce both rapid and sustained immune responses that can have durable anti-viral effects.
        >
        >Positive data from the company's 12-week Phase Ib clinical study of ACTILON in combination with pegylated interferon and ribavirin among treatment-refractory patients, who had initially responded but then relapsed after treatment with pegylated interferon and ribavirin, were presented in April 2006 at the European Association for the Study of the Liver (EASL) meeting in Vienna, Austria.
        >
        >A 48-week Phase II clinical study evaluating safety and activity of ACTILON in combination with pegylated interferon and ribavirin is currently enrolling treatment-refractory HCV patients who never responded after a minimum of 12 weeks of pegylated interferon and ribavirin treatment.
        >
        >Here are links to the study results reported at EASL:
        >EASL: Early Viral Response to New HCV Drug CPG 10101 Toll-Receptor Antagonist, in Combination with Pegylated Interferon and/or Ribavirin, in Chronic HCV Genotype 1 Infected Patients with Prior Relapse Response - (05/09/06)
        >
        >EASL: Randomized, Placebo-Controlled, Dose-Escalation Trial of New HCV Drug CPG 10101 Toll-Receptor Antagonist in Patients with Chronic Hepatitis C Virus - (05/09/06)
        >
        >
        >--------------------------------------------------------------------------------
        >
        >
        >_______________________________________________
        >NATAP nataphcv mailing list -- nataphcv@...
        >
        >This is an annoucement-only mailing list. Do not reply.
        >
        >To unsubscribe: send a blank email to nataphcv-request@... with a subject of unsubscribe.
        >
        >
        >For more information, see http://seven.pairlist.net/mailman/listinfo/nataphcv
        >
        >_______________________________________________
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        >[Non-text portions of this message have been removed]
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      • Alley Pat
        Hey Anne! (and everyone :) It IS good news and I hope more will follow. For me, things are going great! The tumors are shrinking with this trial medication,
        Message 3 of 7 , May 21, 2006
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          Hey Anne! (and everyone :)

          It IS good news and I hope more will follow.

          For me, things are going great! The tumors are shrinking with this trial medication, the side effects are minimal (a little anemia fixed with intestinal bloating iron pills, which I don't take often because I don't wanna ruin my liver with this HCV).

          I've lost my job, but applied for SSDI (disability). It'll be several months before I know anything. I lost my good insurance and hubby's insurance doesn't pay for everything, even meds I've been taking for a long time it wants $100 copay or doesn't pay at all. I'm not happy with that and trying to find alternatives, tho there are no generics for them and the older meds either don't work for me or they give me bad reactions. arg!

          But, I've returned to my writing and hope to finish book one this year at the least and get it sent out and try to finish book 2 and make progress on books 3 and 4 as well as sending out short stories for contests and publication. So I've been busy.

          Course, in the meantime, I'm poor folk again, sacrificing some things to keep my internet and cable TV ( I like being able to record my fave shows to watch when I'm not writing :). But I've rediscovered the library LOL which now has wireless internet and the Atlanta Bread Company where myself and other writers meet to have a "write in", writing together and socializing.

          The list has been pretty quiet lately. Where is everyone? Must be spring :)

          << waves to everyone >>

          Thanks for asking Anne :). How have you been? Anyone talked to Taz?

          Take care,

          Alley
          www.alleypat.com
          www.geocities.com/dfwhcv


          [Non-text portions of this message have been removed]
        • avansi7465
          Dear Alley
          Message 4 of 7 , May 21, 2006
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            Dear Alley<

            I'm so delighted to hear that the tumors are shrinking........that's wonderful!!!!!!

            Insurance is a drag. Thank God that is one thing that I don't have to worry about, although for a time I did.

            Disability should not take months.........more like weeks. I think it took 6 for mine, but I can go back and look it up for you, if you like.

            Can't believe that your job let you go while you were on treatment. You might want to check with their EEO rep on that one. I don't think they can do that unless you were still on probation. But at least you got to go to Holland. Not a bad deal.

            Glad to hear you are writing again. Can I have a quick synopsis? I'm an avid reader, so I"ll be a happy buyer! I've been working on stained glass pieces and jewelry and have sold a surprising amount this Spring. Wish I'd thought to get back to this sooner. It's not a lot, but a couple hundred extra a month is not to be sneezed at (pays for the direct TV, and the internet).

            I got word on Taz from Carol several weeks back. It seems she lost her job because she lied on the application about what she was doing while on treatment and the company found out. I don't know much more than that.

            Keep on writing, girl. Then we cna say we knew you when.............

            TTYL,
            Anne

            -----Original Message-----
            >From: Alley Pat <alleypat@...>
            >Sent: May 21, 2006 1:53 PM
            >To: GIWorld-Hepatitis@yahoogroups.com
            >Subject: Re: [GIWorld-Hepatitis] Fw: NATAP: New HCV Drug CPG 10101-FDA Fast Tracks
            >
            >Hey Anne! (and everyone :)
            >
            >It IS good news and I hope more will follow.
            >
            >For me, things are going great! The tumors are shrinking with this trial medication, the side effects are minimal (a little anemia fixed with intestinal bloating iron pills, which I don't take often because I don't wanna ruin my liver with this HCV).
            >
            >I've lost my job, but applied for SSDI (disability). It'll be several months before I know anything. I lost my good insurance and hubby's insurance doesn't pay for everything, even meds I've been taking for a long time it wants $100 copay or doesn't pay at all. I'm not happy with that and trying to find alternatives, tho there are no generics for them and the older meds either don't work for me or they give me bad reactions. arg!
            >
            >But, I've returned to my writing and hope to finish book one this year at the least and get it sent out and try to finish book 2 and make progress on books 3 and 4 as well as sending out short stories for contests and publication. So I've been busy.
            >
            >Course, in the meantime, I'm poor folk again, sacrificing some things to keep my internet and cable TV ( I like being able to record my fave shows to watch when I'm not writing :). But I've rediscovered the library LOL which now has wireless internet and the Atlanta Bread Company where myself and other writers meet to have a "write in", writing together and socializing.
            >
            >The list has been pretty quiet lately. Where is everyone? Must be spring :)
            >
            ><< waves to everyone >>
            >
            >Thanks for asking Anne :). How have you been? Anyone talked to Taz?
            >
            >Take care,
            >
            >Alley
            >www.alleypat.com
            >www.geocities.com/dfwhcv
            >
            >
            >[Non-text portions of this message have been removed]
            >
            >
            >
            >
            >Welcome to GIHepWorld
            >
            >Post message: GIWorld-Hepatitis@yahoogroups.com
            >Subscribe: GIWorld-Hepatitis-subscribe@yahoogroups.com
            >Unsubscribe: GIWorld-Hepatitis-unsubscribe@yahoogroups.com
            >List owner: GIWorld-Hepatitis-owner@yahoogroups.com
            >URL to this page: http://groups.yahoo.com/group/GIWorld-Hepatitis
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          • Alley Pat
            SSDI said they would contact me with an answer within 90 days. My first check, if I m approved, they said would be six months or so. They also said there s a
            Message 5 of 7 , May 21, 2006
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              SSDI said they would contact me with an answer within 90 days. My first check, if I'm approved, they said would be six months or so. They also said there's a waiting period after stopping work. I just said OKOK to get it over with. I know it's all online.

              I had stopped work before and applied, several years ago after I did those two rounds of interferon, and a few years later, (2005) finally returned to work. I never got my birth certificate in time for their deadline and I just gave up after that. Hubby's job and insurance was great then, so I didn't worry about it too much and worked on my writing and web design business.

              Now tho, it's the real thing. No one is going to hire me when I could only work when I feel like it and then limited with energy. In the meantime, I write :).

              Sure, I'm due to write a synopsis/outline soon on it for a workshop and I'll send you a copy :) It's fantasy/romance, more on the fantasy with romantic elements. I want to be able to market it either way, romance a better seller.

              Thanks :)

              Alley

              [Non-text portions of this message have been removed]
            • avansi7465
              Dear Alley: Somehow I missed this post, but didin t delete it. If you want to try for a publisher, you might want to contact Mann Media in Greensboro, N. C.
              Message 6 of 7 , Aug 26, 2006
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                Dear Alley:

                Somehow I missed this post, but didin't delete it. If you want to try for a publisher, you might want to contact Mann Media in Greensboro, N. C. I don't have more of an address, but you should be able to google them.

                Hope this helps.

                Anne

                -----Original Message-----
                >From: Alley Pat <alleypat@...>
                >Sent: May 21, 2006 3:07 PM
                >To: GIWorld-Hepatitis@yahoogroups.com
                >Subject: Re: [GIWorld-Hepatitis] Fw: NATAP: New HCV Drug CPG 10101-FDA Fast Tracks
                >
                >SSDI said they would contact me with an answer within 90 days. My first check, if I'm approved, they said would be six months or so. They also said there's a waiting period after stopping work. I just said OKOK to get it over with. I know it's all online.
                >
                >I had stopped work before and applied, several years ago after I did those two rounds of interferon, and a few years later, (2005) finally returned to work. I never got my birth certificate in time for their deadline and I just gave up after that. Hubby's job and insurance was great then, so I didn't worry about it too much and worked on my writing and web design business.
                >
                >Now tho, it's the real thing. No one is going to hire me when I could only work when I feel like it and then limited with energy. In the meantime, I write :).
                >
                >Sure, I'm due to write a synopsis/outline soon on it for a workshop and I'll send you a copy :) It's fantasy/romance, more on the fantasy with romantic elements. I want to be able to market it either way, romance a better seller.
                >
                >Thanks :)
                >
                >Alley
                >
                >[Non-text portions of this message have been removed]
                >
                >
                >
                >
                >Welcome to GIHepWorld
                >
                >Post message: GIWorld-Hepatitis@yahoogroups.com
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              • Alley Pat
                Thanks Anne, I m not ready to publish yet, still editing :) Alley [Non-text portions of this message have been removed]
                Message 7 of 7 , Aug 26, 2006
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                  Thanks Anne, I'm not ready to publish yet, still editing :)

                  Alley

                  [Non-text portions of this message have been removed]
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