Renovo Group plc (LSE: RNVO) announced on 11 February 2011 that its first EU Phase III trial for Juvista® in scar revision surgery (REVISETM) did not meet its primary or secondary endpoints. Renovo has now conducted further exploratory analyses of the results of that trial and its implications for Juvista.
The further exploratory analyses have revealed:
- no design, technical, execution or analysis problems were found with the trial
- 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.
In light of these findings the Company regrettably concludes that the efficacy of Juvista is insufficient to demonstrate significant benefit when tested in a broad population of scar revision patients.
The findings are surprising in view of the results of the Phase I and II trials of Juvista, which, as is typical, were conducted in more restricted, controlled populations.
Late yesterday evening, Shire LLC, the Company's commercialisation partner for Juvista, has confirmed that it is terminating the Juvista licensing agreement and in doing so has returned to Renovo the rights to Juvista in the USA, Canada and Mexico.
As a consequence of these events and findings the Board has concluded that:
- no further development of Juvista will be initiated by Renovo; and
- the Company will initiate immediate and significant reductions in expenditure including:
- implementation of a statutory 90 day consultation period to reduce staff headcount by more than 100 including a substantial reduction in the size of the Board; and
- halting recruitment to the ongoing Adaprev® trial, subject to appropriate regulatory and ethical approvals, at the current 32 out of the originally planned 44 patients. This trial should report data in H2 2011 on safety and preliminary performance of Adaprev in improving recovery of tendon function in patients undergoing surgical repair of flexor tendons in Zone II of the hand.
The fully recruited Prevascar® proof of concept clinical trial in incisions and excisions of skin in African volunteers will continue. This trial should report interim data in H1 2011. The interim data are histological and biomarker analyses of Prevascar and placebo treated incisions excised at one month, which may suggest a possible therapeutic use for Prevascar in systemic fibrotic conditions e.g., lung fibrosis. The clinical endpoint of this trial will now be a physician based assessment of the scars treated with the various doses of Prevascar or placebo at month12 and should report data in H1 2012.
The Board is actively exploring all options to maximise shareholder value of the cash and assets including the possible sale of the Juvista, Juvidex, Prevascar, Adaprev and preclinical programmes.
As at 28 February 2011 Renovo had approximately £44 million cash and short term deposits. Renovo is unable to give any financial guidance until after the statutory consultation period.
Professor Mark Ferguson, CEO of Renovo, said "We are extremely surprised and disappointed with the Juvista Phase III trial result in scar revision surgery. The Board is seeking to maximise shareholder value from the remaining assets of Renovo. The significant restructuring consultation plan is sad and difficult for all of Renovo's excellent staff, whom I personally wish to thank for their hard work and dedication".