Invited
Speaker
Avotermin (Juvista®) - A Novel Drug in a New Therapeutic
Field
John Hutchison
Scarring is a natural reaction to tissue injury and an appropriate
defensive response. However scars that result in impairment of function
or physical disfigurement are undesirable. Renovo is developing agents
that reduce the appearance of scars following injury to the skin and
other tissues, whilst preserving appropriate wound-healing responses.
Avotermin (Juvista®) is recombinant human transforming growth
factor β3 (TGFβ3), an important cytokine in embryonic
development1. It has also been shown to improve the macroscopic and
microscopic appearance of scars following surgical wounding in man2.
The optimal regimen for dosing avotermin is two intradermal injections,
one at the time of surgery and the second 24 hours later. A double-blind,
within-patient, placebo-controlled, multi-national, Phase III clinical
trial is currently underway to further investigate improvements in
scar appearance following avotermin treatment in patients undergoing
scar revision surgery for disfiguring scars.
Despite high levels of patient dissatisfaction with surgical scars,
there are currently no licensed pharmaceutical products for scar improvement3.
In developing avotermin, Renovo has overcome the challenges of being
a pioneer in a new therapeutic field, including optimising trial design,
developing endpoints and identifying appropriate patient populations.
Ongoing dialogue with the Regulators will ensure an appropriate filing
strategy for avotermin in the EU.
1. Ferguson MW, and O’Kane S. Scar-free healing; from embryonic
mechanisms to adult therapeutic intervention. Philos Trans R Soc Lond
B Biol Sci 2004:359;839-50.
2. Ferguson MW, Duncan J, Bond J, Bush J, Durani P, Taylor L, Chantrey
J, Mason T, James G, Laverty H, Occleston N, Sattar A, Ludlow, A and
O’Kane S. Prophylactic administration of avotermin for improvement
of skin scarring: three double blind placebo-controlled phase I/II
studies. Lancet 2009;373;1264-74
3. Young VL and Hutchison J. Insights into patient and clinician concerns
about scar appearance: semiquantitative structured surveys. Plast.
Reconstr. Surg;124;1-10
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