Interesting new potential application...
clinuvel.com
Company Announcement
Wednesday 25 August 2010
Melbourne, Australia
Clinuvel to evaluate SCENESSE® as therapy in vitiligo
Pilot study to evaluate drug in pigmentary disorder affecting more than 45 million globally
Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that it will
begin a pilot trial (CUV031) with its first-in-class drug SCENESSE® (afamelanotide) as a repigmentation
therapy in the pigmentary disorder vitiligo. The trial will focus on patients diagnosed with nonsegmental vitiligo
(NSV), the most common form of the disorder which affects approximately 45 million people globally.
During an investigators’ meeting on 21 August in New York, Clinuvel reached agreement with four of the
world’s most prominent and expert centres specialising in vitiligo. Consensus was reached on the protocol and
study design. The trial is scheduled to start in October, subject to obtaining the necessary European and US
regulatory approvals.
SCENESSE® as repigmentation therapy in nonsegmental vitiligo
SCENESSE® is a first-in-class and innovative drug being developed exclusively by Clinuvel. The drug has
been tested in approximately 550 patients in regulated clinical trials. SCENESSE® acts by increasing melanin
levels in the skin attempting to shield against UV radiation (UVR) and sunlight. The drug is delivered by a
small subcutaneous implant approximately the size of a grain of rice. Increased pigmentation of the skin
begins to appear two days after implantation and lasts for up to two months.
This trial will evaluate SCENESSE’s ability to repigment areas of skin with and without the use of narrowband
ultraviolet B (NB-UVB) phototherapy.
Phototherapy, mainly narrow band UVB (NB-UVB), has emerged as a mainstay of repigmentation treatment in
individuals affected by vitiligo. NB-UVB utilises a localised light source to activate melanin in vitiliginous lesions
of the skin. This therapy is known to effectively suppress the local immune response and accelerate the
maturity of melanocytes in the area around hair follicles, which act as melanocyte reservoirs. This process
leads to activation of melanin (pigment). Data from this pilot study will give Clinuvel insight into whether
SCENESSE® as monotherapy is preferable to NB-UVB alone or whether the two treatments combined
provide a superior clinical result.
Commentary
Clinuvel's Chief Scientific Officer, Dr Hank Agersborg said:
“In this study we seek to evaluate SCENESSE® in perhaps in the most logical indication of all, nonsegmental
vitiligo, a disease in which there is a reduction in functional activity of melanocytes. There is great expectation
from the leading scientific experts in the field that SCENESSE® could actually better the currently inadequate
treatment. The two US and two European centres selected are among the most advanced in the treatment of
vitiligo.”
Clinuvel's CEO, Dr Philippe Wolgen said:
“The breakthrough in our thinking is as meaningful as the choice we made to make SCENESSE® available in
vitiligo.
“About two years ago the first long-term results from phototherapy in vitiligo were seen. Frequent sessions of
NB-UVB showed that repopulation of pigment producing cells either from the periphery or from the roots of the
hairs in the skin was possible. This alone was a breakthrough, as previously it had always been thought that
repigmentation of vitiligo was impossible, now we know that partial repigmentation is clinically possible with the
assistance of narrowband UVB.
“Naturally, these academic developments piqued our interest, and we soon understood that the re-emergence
of melanocytes in vitiligo would offer the pharmacological basis for SCENESSE® to assist, and possibly
reduce, the doses of phototherapy.
“It is again clear that SCENESSE® attracts attention from the clinical and academic communities worldwide
and, after years of clinicians petitioning for the drug to be used in vitiligo, Clinuvel has now found sufficient
evidence to support the use of the drug in vitiligo. For patients and shareholders, today’s announcement marks
one of the most exciting directions for Clinuvel.”
Vitiligo
Vitiligo is a common skin disorder in which the pigment producing cells of the skin (melanocytes) are absent or
inadequate. As a result, lighter depigmented patches of skin (target lesions) appear in different parts of the
body due the lack of melanin (pigment). The exact cause of vitiligo is unknown, but it is generally recognised
that an autoimmune component plays a part in this disease. Between 0.1-2% of the global population is
affected by vitiligo and it affects all races. Vitiligo causes significant psychological and emotional distress.
Vitiligo is traditionally separated into two clinical forms: nonsegmental, or generalised, vitiligo (NSV) and
segmental vitiligo (SV), which present with distinctive clinical features and natural histories.
NSV is the most common form of the disease, accounting for 72-95% of the cases. The vitiliginous lesions are
usually symmetrically distributed and new patches may appear throughout the patient’s life. The disease is
progressive with flare-ups. NSV is frequently associated with personal or family history of auto-immunity.
SV is characterised by a unilateral distribution that may totally or partially match a dermatome (area of skin
with innervation from a single spinal nerve) and has an earlier onset and a rapid spread. It may account for
30% of childhood cases. Auto-immune association is rare with SV.
Vitiligo therapy is intended to arrest depigmentation or provide repigmentation of depigmented lesions. Many
treatment options exist but many clinical challenges persist. Not all patients respond to available therapies and
relapse is common.
Clinuvel's clinical focus for SCENESSE®
Nonsegmental vitiligo (NSV) will be the sixth indication to be clinically evaluated by Clinuvel for the novel drug
SCENESSE®.
The company continues to advance its program for the rare light intolerance erythropoietic protoporphyria
(EPP) in Phase II and III confirmatory trials in the USA and Europe. respectively. Positive results were
announced from the first Phase III study of SCENESSE® in EPP in July 2010. Further trials continue to
evaluate SCENESSE® as a photoprotective drug in Europe for patient with severe polymorphic light eruption
and in Europe and Australia as a preventative for certain skin cancers in immune suppressed organ transplant
recipients.
Pending ongoing safety and efficacy in trials, the company expects to file SCENESSE® for marketing
authorisation approval (MAA) for EPP in Europe by 2011.
The company's program, including the pilot NSV trial, is fully costed and funded to its first MAA.
Clinuvel expects that, should the pilot trial NSV prove successful, the company will further pursue NSV in a
larger patient cohort. It is anticipated that results from the pilot trial will be known by Q2 2011. |
