#leftcontainerBox {
border:1px solid #808080;
border-radius:5px 5px 5px 5px;
box-shadow:2px 2px 5px rgba(0,0,0,0.3);float:left;
position: fixed;
top:40%;
left:60px;
z-index:1;
background-color:#F0F4F9}

#leftcontainerBox .buttons {
float:left;
clear:both;
margin:4px 4px 4px 4px;
width:55px;
height:60px;
padding-bottom:2px;
}

#bottomcontainerBox {
border:1px solid #808080;
border-radius:5px 5px 5px 5px;
box-shadow:2px 2px 5px rgba(0,0,0,0.3);float:left;
height:30px;
width:100%;
background-color:#F0F4F9}

#bottomcontainerBox .buttons {
float:left;
height:30px;
width:85px;
margin:4px 4px 4px 4px;
}

Company Announcement Friday 21st October 2011 Melbourne, Australia First positive observations from Clinuvel’s US vitiligo trial Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that early clinical observations from the company’s open label Phase II pilot trial (CUV102) of the novel drug SCENESSE® (afamelanotide) in patients with nonsegmental vitiligo (NSV) were presented [...]

Nathalie speaks with Madelaine Haddican, MD., about the new clinical trials for Clinuvel’s new treatment for vitiligo. Dr. Haddican will describe the study and give qualification details for those wishing to participate in the trial.

Nathalie speaks with Madelaine Haddican, MD., about the new clinical trials for Clinuvel’s new treatment for vitiligo. Dr. Haddican will describe the study and give qualification details for those wishing to participate in the trial.

Lachlan explains exactly how Scenesse works on vitiligo and thoroughly unravels the FDA trial process which Scenesse will undergo. He also gives us an informative background on Clinuvel, the developers of Scenesse, and describes the stipulations and process one needs to know in order to be a part of the FDA trials for Scenesse.

Clinuvel Pharmaceuticals Limited today announced that the US Food and Drug Administration (FDA) has allowed the company to proceed under its current Investigational New Drug to conduct a pilot Phase II clinical trial of its drug afamelanotide (known as SCENESSE®) in patients diagnosed with nonsegmental vitiligo.

Yesterday Cartman left a really great question in our comment area on this post which included a short video, by Clinuvel, which shows how UVB treatments work on Non-segmental vitiligo.
Cartman asked:
What does it mean that UVB treatments only work on Non-segmental vitiligo?
Since I didn’t have the answer, I immediately emailed my contact at Clinuvel and received this answer a few hours later.
Clinuvel said:
Hi Nathalie,
A fair question and one I sent across to a member of our scientific team who reviewed the initial video. I’ve had the following response:
Phototherapy with NB-UVB …

Have you ever wondered exactly how those white patches of skin begin forming below your skins surface? Me, too! Our friends over at Clinuvel have made a really cool video about it, so check it out!

Recently I’ve had the great pleasure of speaking with Lachlan Hay, Head of Global Network and Communications, Media Communications & IT Team @ Clinuvel.  I had many questions about Scenesse®; how it works, the clinical trial process, and when it will be offered world-wide. Mr. Hay was kind enough to answer every question in detail.
Here is the interview:
Recently, the Australian company Clinuvel announced that it would commence a clinical trial of a new drug for vitiligo. The company has received a large number of questions related to its proposed trial …

This is a continuation of the post “The drug development process – Part 1” and “The drug development process – Part 2?
The 3 Phases of clinical trials are strictly monitored and controlled by different regulatory bodies such as the FDA (US), the TGA (Australia), the EMEA (EU) and SwissMedic.
All trials must undergo the same rigorous process as outlined in our previous post, but are quite distinctly different and influenced by a number of other factors.
Phase I trials are carried out on healthy volunteers and are primarily focused on exploring the …

This is a continuation of the post “The drug development process – Part 1”
Clinical trial development must follow a strict and comprehensive process and there are different objectives and focuses for each phase. Generally, phase I trials assess the toxicity of a drug, while phase II focuses on in-depth study of the drugs activity with the chosen condition or indication. Phase III aims to prove the drugs efficacy (efficiency) as a treatment or cure for a condition. However, the safety of the drug is a common consideration throughout the entire …