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VGX Pharmaceuticals announces the discontinuation of its PICTOVIR™ Program
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Bell, PA – July 7, 2008 – |
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VGX Pharmaceuticals, Inc. (VGX) announced today that it will terminate its internal development program of PICTOVIR™, its drug candidate for HIV infection, to focus the Company’s product development efforts on DNA-based vaccines and therapies.
The Company’s decision is based on the following:
- Lack of clinically significant antiviral effects at the doses tested to date as a single therapy.
- Since the standard of care is to treat HIV patients with 3-4 antiretroviral drugs, the current regulatory environment would require VGX to conduct extensive interaction studies on PICTOVIR™ with other HIV drugs on the market, which could take a very long time and be highly expensive.
- The market for HIV drugs has become very competitive – more novel drugs with better safety and efficacy profiles have come to market in the last two years.
- In contrast, there are very few viable vaccine candidates for HIV. VGX will focus its efforts on DNA vaccines and therapies, including its preventative and therapeutic vaccine for HIV, PENNVAX™-B, which is a DNA-based vaccine in clinical trials and supported by the HIV Vaccines Trials Network (HVTN).
“As a dynamic growth company, we must allocate the Company’s resources to the areas with the greatest potential to succeed,” stated Dr. J. Joseph Kim, President and Chief Executive Officer. “VGX will focus its valuable resources on programs that can create the greatest value for our Company and our shareholders.”
Using its vertically integrated DNA product development platform, VGX has taken three independent product programs from ‘Bench to IND filing’ within 12 months. In 2008 alone, the Company has filed and received approval for an IND for a DNA therapeutic vaccine for cervical cancer (VGX-3100), and has filed INDs for a novel DNA therapy that utilizes GHRH for the treatment of cancer cachexia and anemia (VGX-3200) as well as for a DNA preventative vaccine for avian influenza (VGX-3400).
Cautionary
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statements within the meaning of the Securities Litigation Reform
Act of 1995. Forward-looking statements relate to expectations or
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They use words such as "anticipate," "estimate,"
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or future operating or financial performance. In particular, these
include statements relating to future actions, prospective products
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forward-looking statements here or in other publications may turn
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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. |
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 PENNVAX™-B for HIV infection, which is in 2 separate Phase I clinical trials, as well as VGX-1027 for inflammatory diseases, VGX-3100, a DNA therapeutic vaccine for cervical cancer, and the CELLECTRA® electroporation device, all of which are in Phase I clinical trials. In addition, the Company has filed INDs for VGX-3200, a novel DNA therapy that utilizes GHRH for the treatment of cancer cachexia and anemia, and for VGX-3400, a DNA preventative vaccine for avian influenza. VGX has established a vertically-integrated DNA Vaccines and Therapies Platform with extensive capabilities including SynCon™ DNA-based product candidates, the CELLECTRA® delivery device, and efficient cGMP plasmid manufacturing. Vertical control over key aspects of product development has enabled the Company to consistently develop multiple product candidates, from bench-to-IND filing, within 1 year. 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.
Company Contact:
Kevin W. Rassas
Senior Vice President
Tel. 267.440.4208
Fax 267.440.4242
E-mail: Rassas@vgxp.com
www.vgxp.com
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