logo-loader

OncoSil Medical appoints senior pharmaceutical executive as CEO

Last updated: 21:40 11 Nov 2014 AEDT, First published: 22:40 11 Nov 2014 AEDT

pancreatic_cancer_diagram__358x266_54629c6c6f102

OncoSil Medical (ASX:OSL) has appointed Daniel Kenny as its chief executive officer to executive growth plans as it drives towards registration of its OncoSil™ localised radiation therapy medical device for treatment of pancreatic cancer.

The device is currently undergoing trials in Australia and the U.S. as well as progressing towards CE Mark for commercialisation in Europe.

Kenny has almost 30 years’ experience in the global pharmaceutical industry, including senior roles with Roche, Allergan and Baxter. 

He also has more than 10 years of experience in clinical research in the fields of ophthalmology and HIV/AIDS prior to joining the pharmaceutical industry.

Prior to joining OncoSil, he as chief commercial officer and vice president business development at major French biopharmaceutical company, ABIVAX, where he was responsible for the development and implementation of the commercial and business development strategy.

He was also previously global franchise head at Baxter Vaccines, where he successfully reinvigorated the base commercial business and significantly exceeded the business’s financial plan in each of the three years of his tenure. 

Kenny was also vice president Baxter BioScience, EMEA where he was responsible for the marketing and key business programs in support of regional sales exceeding $1.9 billion.

In addition, he was a global lifecycle leader for Roaccutane with Roche, with responsibility for global strategic marketing and business development activities of Roaccutane, an acne treatment product, which generated sales in excess of 1.1 billion Swiss francs (A$1.32 billion) in 2002.

Kenny will be taking the leadership position in driving the development of OncoSil™ with global regulatory authorities. 

This is focused on FDA and EMA approval for pancreatic cancer.

Separately, Dr Neil Frazer has decided to step down from his position on the company’s board with effect from 28 November 2014. 

He will remain with the company in a senior management role.

In September, Dr Roger Aston was appointed executive chairman and Martin Rogers became non-executive director. Dr Neil Frazer moved from CEO to the newly created position of chief medical officer.

   
OncoSil™

The company continues to advance the clinical development pathway for the OncoSil™ device as a new and commercially available option for the treatment of pancreatic cancer, and then marketing the product on a global basis.

It recently commenced a Pivotal Trial that will enrol 150 patients across 20 trial sites.

This will compare patients receiving standard-of-care (for inoperable pancreatic cancer this includes chemotherapy treatment) with patients receiving standard-of-care plus OncoSil treatment, in a randomised and controlled fashion.

The Australian trial is expected to take 12-18 months to evaluate patients and determine their progress.

A key goal of the trial is also to have results published in a prestigious medical journal, with a view to influencing the standard-of-care (the current accepted best practice treatment) provided to pancreatic cancer patients globally. 

Positive, data generated by the Trial may facilitate the commercialisation of OncoSil, including in the US, which is the world's largest health care market. 

The main focus of the Pivotal Trial is for FDA approval and for the results to be published in a prestigious medical journal. The Johns Hopkins University in Baltimore under Professor Joseph Herman is planned for the role of lead investigator.

OncoSil plans to roll-out the trial in Australia, in parallel with trial sites in the UK, Belgium, US and then Singapore. Engaging hospitals as trial sites is a key initial focus, followed by patient recruitment and then the commencement of dosing patients under the trial.

It also continued to make preparations for an Investigational Device Exemption application (IDE) submission for OncoSil to the US Food and Drug Administration (FDA), and expects to submit an IDE in the near future. 

An IDE submission would represent a significant step in the regulatory pathway for OncoSil, and is the first step towards securing the FDA's commercial approval for OncoSil under a Premarket Approval (PMA).



Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

Australian Strategic Materials signs US$600 million LoI

Rowena Smith, CEO and managing director of Australian Strategic Materials Ltd (ASX:ASM, OTC:ASMMF), joins Jonathan Jackson in the Proactive studio to discuss the company’ s Dubbo Project, in Central West New South Wales. This project aims to extract and process critical minerals and rare earth...

10 hours, 13 minutes ago