Date: 2011-02-11
Type of information:
phase: 3
Announcement: results
Company: Renovo (UK)
Product: Juvista® (avotermin - human recombinant Transforming Growth Factor Beta3 [TGFBeta3])
Action mechanism:
Disease: type 1 diabetes
Therapeutic area: Metabolic diseases
Country: UK France, Hungary, Germany, Italy, Poland, Spain, Denmark, Latvia and USA
Trial details:
Latest
news: Renovo Group has announced that its first EU Phase III trial for Juvista® in scar revision surgery (REVISE®) did not meet its primary or secondary endpoints. Renovo will conduct further exploratory analysis and determine the future of the Juvista® development programme. On March 3,2011, Renovo announced that further exploratory analyses of the results of that trial revealed that, despite appropriate inclusion criteria in the protocol and real time monitoring of patient selection, considerable unpredictable variation was found in the appearance of the two halves of the revised scar in some individuals; and no meaningful subset of responders was found in the population of scar revision patients.
So Renovo has concluded that Juvista® is not efficient enough to demonstrate significant benefit when tested in a broad population of scar revision patients. The company has decided to halt the development of the product and its commercialisation partner for Juvista®, Shire, has just confirmed that it is terminating the Juvista® licensing agreement. Shire has also returned to Renovo the rights to Juvista® in the USA, Canada and Mexico.
