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VGX Pharmaceuticals Announces Preliminary Results on the Phase I/II
Clinical Trials of PICTOVIR™.
BLUE BELL, P.A. -- December 29, 2005 --
VGX Pharmaceuticals announced that the Company has received preliminary results on the first
Phase I/II clinical trials of PICTOVIR™, a lead drug compound for the treatment of HIV infection.
This double-blinded, placebo-controlled, multi-center, multi-dose, randomized, Phase I/II study
was conducted in collaborations with the Adults AIDS Clinical Trials Group (AACTG).
The preliminary results indicate that:
o All 3-dose levels were safe and well tolerated.
o There was an indication of antiviral effects at the highest dose tested (225 mg).
o More laboratory tests are currently underway to evaluate whether these dose
levels of PICTOVIR™ improved immune function in HIV-1 infected patients and
also to determine the drug levels of PICTOVIR™ achieved during the study in the
patients’ blood.
Based upon the preliminary results, the company is currently planning to conduct additional
Phase II clinical trials for PICTOVIR™ with higher dosage levels to determine the dosage level
necessary to achieve a clinically significant antiviral effect. The next Phase II clinical study is
planned to begin enrolling patients in the second quarter of 2006. The company also expects to
initiate other Phase III-enabling studies of the drug, including the drug-drug interaction studies in
2006.
PICTOVIR™ is an investigational drug for the treatment of HIV infection. Currently 30 to 50
percent of patients who are treated with current drugs regimens develop resistance to one or
more antiretroviral drugs, reducing the treatment options available to them. Since there is no
effective cure or vaccine for AIDS, HIV drug resistance has become a serious treatment failure
and concern. There is a great need for a new class of drug compound to combat drug
resistances observed with existing compounds. In studies of PICTOVIR™ in non-human
primates, the drug has been shown to effectively reduce viral load in monkeys infected with drugresistant
viruses.
“This is an important milestone both for VGX Pharmaceuticals and for the treatment of HIV
infection,” says J. Joseph Kim, Ph.D., President and CEO of VGX Pharmaceuticals.
“PICTOVIR™ represents a first-in-class HIV Pre-Integration Complex Translocation Inhibitor
(PICT) that could significantly reduce mutation effects of the virus. It is an orally active, smallmolecule
drug that provides once a day convenience.” PICTOVIR™ works by inhibiting the
binding of one of HIV-1 virus’ accessory proteins, Vpr, to its receptors. Vpr plays an important role
for the survival of the HIV-1 virus in human cells, and by inhibiting it the virus is unable to
replicate in many of the body’s important immune cells. In cell culture assays and in animal
models, treatment of virus infected human primary cells by PICTOVIR™ resulted in a significant
inhibition of viral replication of all of the laboratory-adapted and clinical primary isolates of HIV-1
virus. “PICTOVIR™ could make a significant impact for HIV treatment,” said Dr. Kim.
About VGX Pharmaceuticals
VGX Pharmaceuticals is a leading biopharmaceutical company with several product candidates
for the treatment of infectious diseases including HIV and hepatitis C virus (HCV) as well as
cancer. The Company’s clinical development programs include PICTOVIR™ for HIV infection
and VGX-410C for chronic HCV infection, which are currently in Phase II clinical trials. In
addition, VGX Pharmaceuticals’ therapeutic platform is designed to advance a strong and
continual pipeline of drug candidates into the clinic with VGX-150 for cancer treatments and VGX-
750 for toxic-mediated infections currently in development.
About AIDS Clinical Trials Group (ACTG)
The AIDS Clinical Trials Group (ACTG), the largest HIV clinical trials organization in the world,
plays a major role in setting standards of care for HIV infection and opportunistic diseases related
to HIV/AIDS. The ACTG is composed of, and directed by, leading clinical scientists in HIV/AIDS
therapeutic research. The ACTG is funded by the Department of Health and Human Services,
National Institutes of Health (NIH) through the National Institute of Allergy and Infectious