VGX Pharmaceuticals today announced that the DNA plasmid-based product manufactured by VGX on behalf of Nucleonics,Inc. has entered Phase I human clinical trials in the United States and Europe for the treatment of chronic Hepatitis B virus (HBV) infection.
The Nucleonics’ HBV clinical candidate (NUC B1000) is an expressed interfering RNA (eiRNA) based product, consisting of a plasmid DNA construct that encodes four short interfering RNA (siRNA) molecules, each under the control of an RNA polymerase III promoter. Each of the four siRNAs targets a different segment of the HBV genome, collectively leading to the potential destruction or elimination of all RNA species produced by HBV within an infected cell. The result is a potent antiviral effect designed for efficacy against all HBV genotypes, including drug resistant strains.
“VGX’s extensive experience in DNA plasmid manufacturing as well as their responsiveness as an organization to meet our specific needs have been very helpful,” said Dr. C. Satishchandran, Ph.D., Chief Operating Officer and Executive Vice President of Nucleonics. “The level of cooperation by the manufacturing and quality teams at VGX made it seem like they were an extension of our own internal teams."
A second VGX cGMP manufactured plasmid product is a component of a real-time PCR diagnostic kit for fungal infections being developed by Myconostica, ltd. The FXG™: Resp (Asp+) kit has been developed by Myconostica as an aid for the diagnosis of Aspergillus and Pneumocystis fungi, the common causative agents of life-threatening respiratory infections. Over 10 million people are at risk of life threatening respiratory fungal infections in Europe and North America each year and current methods for fungal diagnostics are inherently slow and imprecise.
Commenting on the showcasing of Myconostica’s diagnostic product, Professor David Denning, Research Director of Myconostica said, “There is a great need for precise diagnostics with a rapid turn around time for the diagnosis of disease-causing fungi in respiratory and other clinically relevant tissues and body fluids. VGX’s extensive DNA manufacturing experience and cGMP capabilities were helpful to us in establishing critical standards and controls for our FXG™: Resp (Asp+) molecular test kit.”
“We are very pleased to see the translation of these exciting product candidates progress into human trials,” said Dr. J. Joseph Kim, CEO and President of VGX Pharmaceuticals. “The Nucleonics trial marks the first time that a targeted RNAi therapeutic has been systemically delivered to patients, and VGX is pleased to have been selected to manufacture the product under cGMP to mark this important milestone in the RNAi area. The Myconostica product represents an important aid soon to be available to clinicians in the area of fungal diagnostics. Together, the products highlight the breadth of VGX expertise in tackling complex and diverse projects and adaptability to meet client specific requirements across the broad pharma-diagnostics spectrum.”
He continued, “VGX operates a state-of-the-art cGMP plasmid manufacturing facility to produce products that are in development internally at VGX as well as for partners under contract. We value the external vote of confidence in our manufacturing capabilities brought about through our partnerships. Indeed, VGX carefully selects its manufacturing clients based on their technical excellence and market potential of the products.”
About VGX Pharmaceuticals
VGX Pharmaceuticals is a biopharmaceutical company with small molecule and biologic product candidates for the treatment of infectious diseases, cancer, and inflammatory diseases. The Company’s clinical development programs include PICTOVIR™ for HIV infection, which is in Phase II clinical trials, and PENNVAX™-B, a DNA vaccine for HIV infection, which is in 2 separate Phase I clinical trials. The Company’s lead compound for inflammatory diseases, VGX-1027, is also in Phase I clinical trials. VGX’s research pipeline includes a new generation of SynCon™ DNA vaccines and therapeutics as well as the CELLECTRA™ electroporator, a patented DNA delivery device. The product candidates and technology programs are protected by the Company’s extensive global intellectual property portfolio. More information about VGX can be found at www.vgxp.com.
About VGXI Inc.
VGXI Inc. is a leading provider of DNA plasmid 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 cGMP conditions for client companies’ clinical studies in the US and Europe, and its cGMP and non-cGMP 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. The recently announced research and pre-clinical production services extend the range of high-quality, research grade materials utilizing the same efficient service. This rapid turnaround program provides consistent materials to build a reliable pre-clinical dataset. For information, visit 18.104.22.168/~vgxiico2
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