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Newsletter July 2011

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News: Survey on Risk Assessment in Clinical Trials
Please consider participating in the following survey, which is being conducted by gene therapy and ethics researchers from the University of Sydney. This research aims to investigate how gene therapy researchers take account of considerations of risk when making decisions about the design and conduct of gene therapy clinical trials. The survey is completely anonymous and takes approximately 10-15 minutes to complete.
Complete survey here...

News: Amsterdam Molecular Therapeutics Receives Opinion on Glybera Marketing Authorisation Application
Amsterdam Molecular Therapeutics (Euronext: AMT), a leader in the field of human gene therapy, today announced that it has received an opinion on its Marketing Authorisation Application (MAA) for Glybera® (alipogene tiparvovec) as a potential therapy for Lipoprotein Lipase Deficiency ("LPLD"). Following a recent meeting with the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP), AMT has been notified that, at this time, Glybera is not approvable.
Subsequent to a review of the CHMP's letter, AMT believes that Glybera can receive a positive opinion subject to generating additional data from existing patients. AMT has therefore decided to ask for a re-examination of the clinical data package.

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News: New approach to cancer vaccines proves successful in early studies
University of Leeds researchers, funded by Cancer Research UK, have used a library of DNA to create a vaccine that could be used to treat cancer, according to a study published in Nature Medicine. Before now, ‘gene therapy’ vaccines have often delivered just one gene to stimulate the immune system. It produces a protein, called an antigen, which activates the immune system to destroy cancer cells. It has been difficult to develop successful cancer vaccines because each tumour has specific proteins and identifying the right antigens has been a huge challenge.
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Report: Gene Therapy in China - From a Dutch perspective
The drug approvals in China for Gendicine in 2003 and Oncorine in 2005 for cancer gene therapy startled the world. The issue of medical tourism for gene therapy treatment in China was unprecedented. However, in recent years the special attention for gene therapy developments in China has faded.
The present study was initiated by The Netherlands Commission on Genetic Modification (COGEM) to retrieve information from Chinese sources, esp. Chinese literature databases, Chinese scientists, scientific meetings in China, on gene therapy developments and risk assessment.
Even though recently no special hallmarks have been reported on gene therapy in China, the number of publications on gene therapy has increased nearly 10-fold between 2000 and 2009, esp. in the last 5 years, whereas these numbers were more or less stable in other countries. Research in China is as broad as in the rest of the world. A prominent focus is apparent to disease areas that have a relative high prevalence in China, e.g., liver related disorders. The total number of clinical studies approved in China that could be retrieved was 44. More than 10 companies in China are directed at gene therapy. It is difficult to predict how the gene therapy field will further evolve in China. However, it is obvious that China still has the potential to become the country with the most clinical data from gene therapy patients. Recording and publication of these data, should be further improved in order to substantiate clinical developments in the gene therapy field.

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Poll: The development of which type of adenoviral vector for (solid) cancer gene therapy treatments is most promising and should be supported?
Gene Therapy Net started a new poll regarding the development of adenoviral vectors for cancer gene therapy. What do you think? Vote now!
1- Suicide gene therapy adenoviral vectors expressing HSV-TK, or
2- Tumor specific replication competent adenoviral vectors (like CrAd), or
3- Immuno stimulating adenoviral vectors (like GM-CSF expressing), or
4- Tumor antigen expressing adenoviral vectors (like Mart-1 for melanoma)

Vote now...

Conferences
- 15 – 17 July 2011, The 17th Annual Meeting of the Japan Society of Gene Therapy (JSGT), Kyushu University, Fukuoka, Japan
- 16 – 18 August 2011, ImVacS: The Immunotherapeutics & Vaccine Summit, Cambridge, MA
- 19 - 21 September 2011, Phacilitate’s 1st Asian Cell & Gene Therapy Forum, Singapore
- 21 - 23 September 2011, Annual Meeting of the Spanish Society of Gene and Cell Therapy (SETGyC), Zaragoza, Spain
- 26 - 27 September 2011, ASGCT - NIH Gene Therapy Symposium, Bethesda, MD
- 27 - 31 October 2011, European Society Of Gene & Cell Therapy (ESGCT) and the British Society of Gene Therapy (BSGT) collaborative Congress 2011, Brighton, UK
- 8 November 2011, 4rd annual Workshop on Genome Engineering, Seattle, WA
- 16 - 18 November 2011, 10th Annual Gene Therapy Symposium for Heart, Lung, and Blood Diseases. Focus Topic: Cell Trafficking and the Niche, Sonoma, CA
- 30 January - 1 February 2012, Phacilitate 8th Annual Cell & Gene Therapy Forum 2012, Washington DC, MD
- 2 -5 February 2012, Up Close and Personalized, International Congress on Personalized Medicine, Florence, Italy
- 16 – 20 May 2012, American Society of Gene and Cell Therapy (ASGCT) 15th Annual Meeting, Philadelphia, PA
- 5 – 8 June 2012, International Society for Cellular Therapy (ISCT) 18th Annual Meeting, Seattle, WA
- 5 – 6 October 2012, International Society for Cell & Gene Therapy of Cancer - 2012 Singapore Conference, Singapore

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