Clinical Development Strategy

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Zywie is currently working with the FDA to confirm the clinical and pre-clinical requirements to support approval of Ziva for the treatment of T3 GD. Based on this guidance, Zywie plans to finalize its proposed protocol for two Phase 2/3 placebo-controlled pivotal studies with an integrated natural history study. Zywie has been granted orphan drug designation by the US FDA for the use of Ziva in the treatment of GD.

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source url Well-Defined Primary Endpoint FOR TYPE 3 GD

Zywie has completed a meta-analysis of T3 GD and has used these findings to design a clinical study that will provide sufficient data on the safety and effectiveness of Ziva to support a near-term decision on its approvability for marketing as a new treatment for T3 GD.

  • To minimize the risk of delay, Zywie will proceed with two pivotal studies and plan to file for approval based on the results of the first pivotal study.
  • Ziva is a potential treatment for an orphan disease with no approved treatment.

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POTENTIAL OPPORTUNITIES BEYOND TYPE 3 GD

Zywie is also evaluating the potential to pursue other indications, including:

  • Type I Gaucher Disease (a substantially larger market than Type 3 GD because there are about 20 times more patients with T1 than with T3 GD)
  • Lewy Body Dementia (a subset of Parkinson’s Disease with significant neurological symptoms)
  • Other subsets of patients with Parkinson’s Disease (which has a similar disease mechanism that is likely to respond to treatment with Ziva).

There’s a significant overlap between Gaucher and Parkinson’s. Please see Publications Section for a large number of both studies and assumptions.