Positive Data Announced in Phase IIb Clinical Trial of Cystic Fibrosis Gene Therapy Manufactured by VGXI, Inc.

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Positive clinical data has been published for a cystic fibrosis gene therapy clinical trial supported by the cGMP plasmid DNA manufacturing services of the Texas-based CMO, VGXI.

GMP Plasmid Gene Therapy

Plasmid Gene Therapy Product

The entire VGXI team is committed to providing the highest quality DNA products and services, and it is rewarding to see these products make a meaningful impact on patients’ quality of life

Recently, the United Kingdom Cystic Fibrosis Gene Therapy Consortium (UKCFGTC) published the first clinical data from a Phase IIb, multi-dose clinical trial for cystic fibrosis. In this trial, patients received aerosolized DNA plasmid expressing Cystic Fibrosis Transmembrane Conductance Receptor (CFTR), manufactured at the VGXI cGMP production facility. This trial is the first to show that gene therapy can have a meaningful effect on the disease and benefit the lung function of patients with cystic fibrosis.

“One hundred and thirty-six patients aged 12 and above received monthly, inhaled doses of the gene therapy or a placebo for 1 year,” said Professor Deborah Gill, from Oxford University. “The results are encouraging and are expected to lead to a further study to assess higher, more frequent doses.”

VGXI is pleased to have provided over 10 years of continued support for the UKCFGTC’s translational program.

“We are delighted that the UKCFGTC has continued to trust in VGXI’s manufacturing capabilities,” said Mr. Young Park, President and CEO of VGXI. “The entire VGXI team is committed to providing the highest quality DNA products and services, and it is rewarding to see these products make a meaningful impact on patients’ quality of life.”

Since 2005, VGXI and the UKCFGTC have entered into several, multi-year supply agreements for production of the CFTR plasmid product to support the pre-clinical, product development, and clinical programs of the consortium. As part of this partnership, the highly experienced scientific staff at VGXI has enabled significant improvement in production yields through a combination of plasmid re-design and optimization of the fermentation and recovery process. As the clinical program advances toward later stage trials and commercial availability, VGXI looks forward to providing continued, large-scale manufacturing support.

With over 15 years of experience, VGXI Inc. is a leading provider of plasmid DNA manufacturing and development services for DNA vaccine and gene therapy research. The company has an outstanding track record of success in manufacturing plasmid products under GMP conditions for clinical trials in the US, EU, Asia and Australia, and its cGMP and non-GMP products have passed rigorous reviews by several international regulatory agencies. VGXI’s ability to work with unique requirements and create custom manufacturing solutions is based on its patented manufacturing process, flexible cGMP production facility, and experienced development team. VGXI is a wholly-owned subsidiary of GeneOne Life Science, Inc. (KRX:011000)

For further information on the work of the UKCFGTC, please visit http://www.cfgenetherapy.org.uk
For the full text publication and clinical data, please visit http://www.TheLancet.com

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Christy Franco
VGXI, Inc.
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