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LiRIS News! TARIS launches Second Phase 2 Clinical Study for Interstitial Cystitis

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  • LiRIS News! TARIS launches Second Phase 2 Clinical Study for Interstitial Cystitis

    (Very exciting news my friends! LiRIS®is a promising new therapy for IC, particularly for patients who have Hunner's ulcers/lesions. In their first study, conducted in 2011, sixteen women treated with the LiRIS device showed clinically meaningfully reductions in their IC symptoms but what was shocking was that 5 of 6 women with Hunner's Lesions showed a complete "resolution" of the ulcers after two weeks of treatment. Think about it. Hunner's lesions, considered the most severe form of IC, were healing in two weeks. Obviously, the IC research and patient communities became very excited. Last year, they launched their first Phase II study in the USA which was suspended later in the year. After reviewing the data from that study, they found that the results were encouraging enough to launch a second Phase II study today! I couldn't be more thrilled. I consider this to be the first truly revolutionary breakthrough in the treatment of IC and I encourage patients to learn about LiRIS and to consider participating in some way, especially if they have Hunner's ulcers/lesions that have not responded to other therapy. The clinical trial centers will be announced within a few days. - Jill Osborne MA)

    TARIS® Announces Dosing of First Patient in Second Phase 2 Clinical Study of LiRIS® in Interstitial Cystitis

    Lexington, MA – April 2nd, 2013 – TARIS Biomedical®, a specialty pharmaceutical company developing
    innovative, targeted therapies to treat bladder diseases with high unmet medical need, announced
    today that it has dosed the first patient in its second Phase 2 clinical study with LiRIS®, its novel product
    candidate, in patients with Interstitial Cystitis (IC). LiRIS® is designed to continuously deliver lidocaine
    over an extended period directly to the bladder of patients with IC, to relieve the painful and often
    debilitating symptoms associated with this disease.

    “TARIS®’ first Phase 2 study provided important insights into both the disease and the benefit of LiRIS
    relative to placebo in this patient population. This new study incorporates these learnings,” said J. Curtis
    Nickel, MD, FRCSC, Professor of Urology, Queens University, Canada, and the trial’s principal
    investigator. Dr. Purnanand Sarma, PhD, President and CEO of TARIS® said, “We anticipate this new
    study will provide necessary data that will enable us to design a successful registration program.
    Interstitial Cystitis continues to be a significant unmet medical need, and we believe our technology can
    fundamentally change the treatment of this debilitating condition.”

    This multi‐center, randomized, double‐blind, placebo-controlled Phase 2 clinical study will evaluate the
    safety and efficacy of LiRIS® in up to 124 patients with Interstitial Cystitis. Patients who successfully
    complete the randomized trial will be eligible to participate in a subsequent open-label extension arm
    where all patients are eligible to receive LiRIS®. TARIS® plans to conduct this study in up to 15
    investigational sites in the US and Canada.

    In a separate release issued today, TARIS Biomedical® also announced that it has closed a $12.5M
    financing, led by its existing investors, Flagship Ventures, Flybridge Capital Partners, Polaris Partners and
    Third Rock Ventures.

    In addition to Interstitial Cystitis, TARIS® is developing a pipeline of novel, targeted therapies designed
    to treat a variety of bladder diseases, such as bladder cancer and urinary incontinence, utilizing its novel
    targeted bladder delivery system.

    Additional Info:

    - Osborne, J. Early LiRIS® Trial Results Show Healing of Hunner's Ulcers. ICN E-Newsletter May 2012 -

    - Nickel JC, et al. Continuous intravesical lidocaine treatment for interstitial cystitis/bladder pain syndrome: safety and efficacy of a new drug delivery device. Sci Transl Med. 2012 Jul 18;4(143):143 -

    - Press Release April 2, 2013 - TARIS® Announces Dosing of First Patient in Second Phase 2 Clinical Study of LiRIS® in Interstitial Cystitis -
    Would you like to talk with someone about your IC struggles? The ICN now offers personal coaching sessions that include myself, Julie Beyer RD on the diet and Dr. Heather Howard on Sexuality.

    Looking for books, magazines & reports on IC? Please visit the ICN Shop at: Your ICN subscription & purchases in our shop support these message boards, chats and special events. BECOME AN ICN ANGEL TODAY!

    Please remember that the information on the ICN is provided with the understanding that ICN, its founder, staff, volunteers, and participants are not engaged in rendering medical or professional medical services. We cannot and do not give medical advice. Only your personal physician can do this for you.

  • #2
    wonderfull news


    • #3
      Alleluia! I suffer from numerous hunner's ulcers and nothing has been helping me lately with the pain and resulting frequency. Steroid injections no longer work and make the ulcers worse and cauterizing the ulcers only provides me with a month or two of some relief. Additionally, these outpatient procedures are expensive even with insurance.

      My life is currently on hold so this LIRIS device gives me some hope although it probably won't get FDA approved anytime soon.

      Thanks Jill


      • #4
        Jill - do you happen to know if there is something specific that limits LIRIS to use only in women? I went on the clinical trials site, and they are only seeking female participants.


        • #5
          I was part of the last trial, I went through the first round and was looking forward to the second round where I would get the lidocaine. Unfortunately the trial was stopped before I was able to have the second pretzel placed. Does anyone know if t hey will allow me to continue with the second round?


          • #6
            Good news
            Diagnosed in 2005.
            Currently take Tramadol 50 mg, Amtryptiline 25 mg, and Hydroxizine 50mg at bedtime. Also take Pyridiium or Ultira-C on a rotating basis, and Gelnique as needed as well.


            • #7
              A question about the trial...


              I wondered whether you have undergone treatment did improve your situation?




              • #8
                Yes very much so, I felt better for months.


                • #9
                  Originally posted by signgal View Post
                  Yes very much so, I felt better for months.
                  Your things give me hope,

                  Can you share with us information about the treatment and the difference from the currently available therapies?

                  Do you know the reason for the cancellation experiments?

                  Do you know something about the new experiments?

                  ty for your answer.



                  • #10
                    Shlomi, when I participated in the trail I went through a screening process to determine if I was a good candidate. I needed to keep a log of my bathroom habits and pain. Then I had the procedure done. You may recieve the device with the medicine ( lidocaine) or just the device without the medicine or you might recieve neither. You continue to record your bathroom trips and pain level. After two weeks they will go back in and retrieve the device and once again you will keep records for, I believe, another two weeks. Hope that answers your questions


                    • #11

                      Ty very much for your answers,

                      Your trial included lidocain?

                      You think that this product will improve our life?



                      • #12
                        Yes, I believe I had the device with lidocaine. And yes, I believe that once this device is available it will help many of us, especially if you have hunners ulcers.


                        • #13
                          Great news!!!


                          • #14
                            Re: LiRIS News! TARIS launches Second Phase 2 Clinical Study for Interstitial Cystiti

                            Hi, I am first on the list at my local hospital for the Liris trial coming here soon. I don't have Hunner's ulcers. I have the "glommerations" in all 4 quadrants of my bladder. I burn very badly in the lower bladder and urethra. I am on daily instillations. As soon as I inject an instillation, I feel immediate relief, but it does not last because of the steady supply of fresh urine, which is of course, is offensive to my bladder. Liris sounds like it might be just the thing for me since it gives a steady fresh dose, I guess "keeping up with the supply of urine". Just wondered if you have continuing access to Liris even though it is not FDA approved yet. I had read that Hunner's ulcers returned in these women, but Liris was reinserted to "do it's thing again." I thought, "Well, someone had to have continuing access to this, or they wouldn't know that it would work "again". I hope the FDA fast tracks this through fast. I need help NOW!! I am just dying to know if this works in those with "glommerations."


                            • #15
                              Re: LiRIS News! TARIS launches Second Phase 2 Clinical Study for Interstitial Cystiti

                              Just wondered if you could tell me what the screening process was. Like.....what kinds of questions they asked. What makes a good candidate? What other therapies were allowed during the trial? Also, was there like.......a "stampede of patients" trying to get in or was it easy to "get a slot." I know some folks are hesitant to participate in a trial, but I'm chomping at the bit to try it. Just wondered if there was alot of interest, ie "a line of applicants a mile long."