VGX Pharmaceuticals, Inc., a leading manufacturer of cGMP-grade DNA plasmids, announced today that it has expanded its manufacturing capacity with the installation and testing of a new 500-liter scale fermentor in its cGMP manufacturing facility in The Woodlands, Texas. The new fermentor gives VGX significantly more flexibility than its current 100-liter production scale.
In addition to manufacturing DNA plasmids for its own product development purposes, VGX has been offering contract manufacturing services to outside client organizations with the flexible, state of the art facility used for research, development, and clinical supply. VGX-manufactured products have passed rigorous reviews by several international regulatory agencies.
“This upgrade represents the initial phase of enhancing VGX’s capabilities to manufacture DNA plasmids for clinical and eventually commercial applications,” said Dr. J. Joseph Kim, President and CEO of VGX. “We will continue to enhance our manufacturing capabilities and capacity to meet the increasing demand for our own DNA-based vaccine and therapy product candidates as well as those of our clients.”
VGX Pharmaceuticals has initiated IND-enabling pre-clinical toxicology studies for three of its DNA plasmid-based product candidates. The candidates include vaccines for human papilloma virus for the treatment of cervical cancer (VGX-3100) and avian influenza (VGX-3400), and a therapeutic based on human growth hormone releasing hormone (VGX-3200) for cancer-related cachexia. The Company expects to file Investigational New Drug Applications (INDs) for all three products by June 2008.
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 188.8.131.52/~vgxiico2
Cautionary Factors That May Affect Future Results
Materials in this Web site contain information that includes or is based upon forward-looking statements within the meaning of the Securities Litigation Reform Act of 1995. Forward-looking statements relate to expectations or forecasts of future events. You can identify these statements by the fact that they do not relate strictly to historical or current facts. They use words such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” and other words and terms of similar meaning in connection with a discussion of potential future events, circumstances or future operating or financial performance. In particular, these include statements relating to future actions, prospective products or product approvals, future performance or results of current and anticipated products, sales efforts, expenses, the outcome of contingencies such as legal proceedings, and financial results. Any or all of our forward-looking statements here or in other publications may turn out to be wrong. They can be affected by inaccurate assumptions or by known or unknown risks and uncertainties. Many such factors will be important in determining our actual future results. Consequently, no forward-looking statement can be guaranteed, and forward-looking statements may be adversely affected by factors, including general market conditions, competitive product development, product availability, current and future branded and generic competition, federal and state regulations and legislation, manufacturing issues, timing of the elimination of trade buying, patent positions, litigations and investigations.Our actual results may vary materially, and there are no guarantees about the performance or valuation of VGX stock. It is also important to read the disclosure notice contained in many of the individual VGX documents available on this Web site as many contain important information on such cautionary factors as of the date of the individual document. We undertake no obligation to correct or update any forward-looking statements, whether as a result of new information, future events or otherwise. You are advised, however, to consult any further disclosures we make on related subjects in our reports.