Understanding clinical trial results – P values

Friday, December 11th, 2009

Clinical trials are complicated and often the results can be even more so. Close monitoring of the interactions between patients, diseases, conditions and drugs for extended periods of time and the various questions posed in order to prove or disprove safety and efficacy of particular treatments result in an accurate yet highly complex mountain of data.

Clinical trials are conducted to answer a specific question about a treatment, usually related to safety and efficacy. This involves the development of a hypothesis, and then the running of clinical trials to collect data and to demonstrate the validity of the hypothesis using statistical analysis.

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The Clinuvel AGM

Tuesday, November 24th, 2009

melbournetownhallAs many of you may know, this week saw Clinuvel hold its Annual General Meeting in the Melbourne Town Hall. As managing director I welcome these opportunities where I am able to meet and talk to the people whom Clinuvel considers integral to the company and its existence; the Board of Directors sees Clinuvel’s investors as unique. In Clinuvel, an investor has to fundamentally believe in the premise of offering pharmaceutical photoprotection, a novel option, an innovative approach to skin disorders.

In a meeting that would be considered short by international standards I was both excited and proud to present some of the achievements and milestones our team has reached this year, and lay out our plans for the next 12 months.

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A brief history of afamelanotide

Friday, October 9th, 2009

Photoart_0117The research that underpins afamelanotide began over 20 years ago in the US. At that time the dramatic increase in incidence of skin cancer and its impacts were beginning to be discovered and new solutions sought. The National Cancer Institute (NCI) sponsored researchers to explore applications for various peptides as part of its melanoma prevention strategy.

This study led them to investigate peptides that acted on melanocyte receptors. The rationale behind this being that increased melanin leads to more efficient photoprotection, as melanin is a highly successful and naturally occurring UV quencher and filter. By consistently increasing melanin in the skin, skin damage from light and UV radiation can be lessened.

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Killing cancer in the UK

Thursday, October 8th, 2009

unitedkingdomA new initiative has just launched in the UK with the goal of increasing awareness and support for the more widespread use of photodynamic therapy (PDT). Compared to surgery and chemotherapy, PDT is a relatively simple, quick and effective treatment for certain types of cancer that we have covered previously on this blog.

Killingcancer.co.uk is a fundraising initiative aiming to create both a groundswell of interest and a pool of funds to support the development and access to PDT in the UK, to make it more readily available through the National Health Service (NHS). Through a mix of celebrity endorsements and patient stories they build an informative and compelling case for their cause.

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Two conferences, one city

Friday, October 2nd, 2009

newyorkThose of you that follow pharmaceutical development and Clinuvel in particular will know that we recently presented at Rodman and Renshaw’s 11th Annual Healthcare Conference in New York. It’s serendipitous that the following week found another conference taking place in the same city, although involving a rather different topic. The coincidence draws attention to a connection that is of increasing urgency and importance.

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Green pharma and the path to sustainable, responsible drug development

Friday, September 18th, 2009

earth_2A most interesting movement that’s gathering steam within pharmaceutical development is that of Green Pharma.

The concept began in Germany and Sweden, home to many environmentally and socially aware initiatives. Simply put, Green Pharma is the practice of considering the broader implications and consequences of the entire process of drug development and striving to ensure that when a drug gets to market it can be considered benign by design.

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Clinuvel’s regulatory strategy – Dr Hank Agersborg

Monday, August 31st, 2009

sidebar_podcastDr. Hank Agersborg is Clinuvel’s Chief Scientific Officer. With over 50 years working in the industry, his insights and experience span some of the most dynamic and exciting eras of change and evolution that this sector has seen.

In this interview he discusses the company’s regulatory strategy following the announcement of a confirmatory Phase III EPP study.

Click here to listen or download.

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Light, life’s invisible paradox

Friday, August 28th, 2009

Photoart_0117During more than a decade of clinical research on Clinuvel’s proprietary drug afamelanotide, our teams have specialised in, and focused on, the study and importance of light absorption for our health and well-being.

However, light is regarded as an ‘optical paradox’: too little may result in vitamin D deficiency or seasonal affective disorder (SAD), while too much may result in skin cancer. In seeking answers from related fields, our in-house scientists often remark that human biology is unfortunate to lack green chlorophyll with its ability to efficiently process light into nutrition.

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Light and UV in Australia

Tuesday, August 25th, 2009

Australians have a love for their outdoors and a great appreciation for sunshine. With our appreciation comes understanding, and with that understanding, a healthy respect of the sun.

In Australia, sun safety is paramount and education starts early. Year round, Australians are exposed to high levels of UV; two in three Australians are expected to be diagnosed with skin cancer by the age of 80. Education in sun awareness is essential: even during a Melbourne winter, UV levels can be high, skin damage can occur on overcast days.

Recognising the potentially harmful properties of both controlled artificial light and natural light, at Clinuvel we have built an Australian company to compliment Australia’s awareness in light and UV: using this understanding in our research into medicinal photoprotection.

Light and UV in Australia from Clinuvel Australia on Vimeo.

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CEO’s welcome message

Friday, August 21st, 2009

Photoart_0117The launch of Clinuvel’s New Media channels mark the start of an exciting era in the company’s evolution. Although online information channels are not strictly part of classical pharmaceutical development, I believe that direct communication with drug developers will become the norm in our industry as part of greater accountability and transparency. Looking ahead, I wish to see Clinuvel in a leading position, not only by the progressive development of our ‘orphan drug’ afamelanotide, but also in the way we are communicating to the world.

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