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TIS update from BiosharesTissue Therapies (TIS: $0.47), the...

  1. 21 Posts.
    TIS update from Bioshares

    Tissue Therapies (TIS: $0.47), the developer of the VitroGro wound healing product, may have gained an important commercial advantage this week when Shire Pharmaceuticals announced the failure of Dermagraft, a wound healing product, in a 500 patient pivotal trial in venous leg ulcer patients.

    Dermagraft did not meet its endpoint of achieving complete healing, defined as 100% re-epithelialization with no presence of scab of drainage, at 16 weeks. Dermagraft showed a higher rate of closure when combined with compression therapy. However, the product also needed to show a minimum level of absolute superiority over compression therapy.

    Shire Pharmaceuticals acquired Advanced Biohealing, the developer of Dermagraft, in May for US$750 million. Dermagraft is approved for the treatment of full-thickness diabetic foot ulcers of greater than six weeks duration.

    The Dermagraft venous leg ulcer trial failure is relevant to Tissue Therapies, because it is conducting a trial in venous ulcer patients. Interim data in its trial showed complete healing in eight of 24 evaluated patients, with Vitrogro administered once or twice weekly for 12 weeks in patients who did not respond to compression therapy.

    With competition now freed up in the venous ulcer market, a refreshed opportunity exists for Tissue Therapies, or more likely with a commercial partner, to tackle the broader venous ulcer market. We would expect a clinical development program similar to the randomised 500 patient Dermagraft pivotal trial to be adopted. However, the key point for Tissue Therapy investors is that the broader venous ulcer market is up for grabs again for new technologies.
 
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