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Newsletter April 2014

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News: FDA Grants Breakthrough Status to Gene Therapy for First Time
Celladon today became the first company to receive breakthrough status for a gene therapy treatment in development. The treatment, MYDICAR, is intended to reduce the risk of heart failure in patients with a deficiency of the enzyme SERCA2a. The FDA made its decision to grant breakthrough status to MYDICAR on the basis of Celladon's Phase 1 trial of 39 systolic dysfunction patients. The study reported that subjects receiving high doses of MYDICAR experienced fewer heart failure events than subjects given a placebo, by a factor of more than 80%, and that this reduction was sustained for three years after treatment. No safety issues were reported in this initial trial. Breakthrough status, which is reserved for treatments targeting life-threatening diseases that show significant improvements over the standard of care, allows closer communication with the FDA and potentially an accelerated approval process.
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News: Stem cell gene therapy: Chances and risks
Physicians and scientists from Munich and Heidelberg have now proven the long-term effectiveness of stem cell gene therapy, based on a study of patients from the first clinical trial worldwide using gene therapy to treat Wiskott-Aldrich syndrome. Yet several years after the therapy, the researchers also observed an increased incidence of acute leukemia among the patients.
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Conferences
- 23 - 26 April 2014, International Society for Cellular Therapy (ISCT) 20th Annual Meeting, Paris, France
- 21 – 24 May 2014, American Society of Gene and Cell Therapy (ASGCT) 17th Annual Meeting, Washington, DC
- 2 – 3 June 2014, 3. Laupheimer Zelltage - Processes for Virus-based Biologics, Laupheim, Germany
- 6 – 8 August 2014, The 20th Annual Meeting of the Japan Society of Gene Therapy (JSGT), Tokio, Japan
- 25 – 27 September 2014, 14th Annual Meeting of the International Society for Cell & Gene Therapy of Cancer, Amsterdam, The Netherlands
- 23 – 26 October 2014, XXII Congress of the European Society of Gene and Cell Therapy (ESGCT), The Hague, The Netherlands
- 27 – 29 October 2014, 3rd International Conference and Exhibition on Cell & Gene Therapy, Las Vegas, NV
- November 2014, Formulation and Drug Delivery Congress, London, UK
- November 2014, Cell Therapy Congress, London, UK

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Gene Therapy Net is the information resource for basic and clinical research in gene therapy, and the site serves as a network in the exchange of gene therapy information and breaking news items. Visitors can keep track of the latest scientific papers, conference announcements, gene therapy jobs, regulations and guidelines. Other information websites created and maintained by the owner of Gene Therapy Net are Dengue Virus Net, Influenza Virus Net and Chikungunya Virus Net.
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Gene Therapy Net Banner
News: FDA Grants Breakthrough Status to Gene Therapy for First Time
Celladon today became the first company to receive breakthrough status for a gene therapy treatment in development. The treatment, MYDICAR, is intended to reduce the risk of heart failure in patients with a deficiency of the enzyme SERCA2a. The FDA made its decision to grant breakthrough status to MYDICAR on the basis of Celladon's Phase 1 trial of 39 systolic dysfunction patients. The study reported that subjects receiving high doses of MYDICAR experienced fewer heart failure events than subjects given a placebo, by a factor of more than 80%, and that this reduction was sustained for three years after treatment. No safety issues were reported in this initial trial. Breakthrough status, which is reserved for treatments targeting life-threatening diseases that show significant improvements over the standard of care, allows closer communication with the FDA and potentially an accelerated approval process.
Read more...

News: Stem cell gene therapy: Chances and risks
Physicians and scientists from Munich and Heidelberg have now proven the long-term effectiveness of stem cell gene therapy, based on a study of patients from the first clinical trial worldwide using gene therapy to treat Wiskott-Aldrich syndrome. Yet several years after the therapy, the researchers also observed an increased incidence of acute leukemia among the patients.
Read more...

Conferences
- 23 - 26 April 2014, International Society for Cellular Therapy (ISCT) 20th Annual Meeting, Paris, France
- 21 – 24 May 2014, American Society of Gene and Cell Therapy (ASGCT) 17th Annual Meeting, Washington, DC
- 2 – 3 June 2014, 3. Laupheimer Zelltage - Processes for Virus-based Biologics, Laupheim, Germany
- 6 – 8 August 2014, The 20th Annual Meeting of the Japan Society of Gene Therapy (JSGT), Tokio, Japan
- 25 – 27 September 2014, 14th Annual Meeting of the International Society for Cell & Gene Therapy of Cancer, Amsterdam, The Netherlands
- 23 – 26 October 2014, XXII Congress of the European Society of Gene and Cell Therapy (ESGCT), The Hague, The Netherlands
- 27 – 29 October 2014, 3rd International Conference and Exhibition on Cell & Gene Therapy, Las Vegas, NV
- November 2014, Formulation and Drug Delivery Congress, London, UK
- November 2014, Cell Therapy Congress, London, UK

Read more...

Gene Therapy Net is the information resource for basic and clinical research in gene therapy, and the site serves as a network in the exchange of gene therapy information and breaking news items. Visitors can keep track of the latest scientific papers, conference announcements, gene therapy jobs, regulations and guidelines. Other information websites created and maintained by the owner of Gene Therapy Net are Dengue Virus Net, Influenza Virus Net and Chikungunya Virus Net.
To unsubscribe from the Newsletter, please login and edit your subscription details or contact us. You are currently registered as: {subtag:name}, email address: {subtag:email}.