VGX Pharmaceuticals Provides Update on Additional Phase II Clinical Trial for PICTOVIR™....에이즈 사진자료
VGX Pharmaceuticals announced today that the IRB at Georgetown University approved the initiation of an additional Phase II clinical trial for PICTOVIR™, VGX’s leading compound for the treatment of HIV infection.
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 known effective cure or vaccine for AIDS, HIV drug resistance has become a serious treatment concern. There is a great need for a new class of drug compound to combat drug resistances observed with existing compounds.
The first PICTOVIR™ Phase I/II clinical study was completed in 2005 under an IND held by the National Institutes of Allergy and Infectious Diseases in collaboration with VGX Pharmaceuticals. Based upon the preliminary results, the Company opened its own IND to support additional Phase II clinical trials for PICTOVIR™ with higher doses to determine the dosage level necessary to achieve a clinically significant antiviral effect. Additional information can be obtained at the National Institute of Health’s website, www.clinicaltrials.gov, with an Identifier number, NCT00352911.
“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™ is a first drug in a new class of HIV drugs targeting the Pre-Integration Complex Translocation (PICT). It is an orally active, small-molecule drug.” PICTOVIR™ works by preventing the transporting of PIC to the nucleus of many of the body’s important immune cells. By inhibiting this mechanism, PICTOVIR™ can prevent the replication of HIV. In cell culture assays and in animal models, treatment of virus infected human primary cells by PICTOVIR™ at low doses resulted in a significant inhibition of viral replication of all of the laboratory-adapted and clinical primary isolates of HIV-1 virus. Additionally, in studies of PICTOVIR™ in non-human primates, the drug has been shown to effectively reduce viral load in monkeys infected with multi drug-resistant (MDR) viruses. “PICTOVIR™ could make a significant impact for HIV treatment,” said Dr. Kim.
“We are very excited to initiate this additional study for the development of PICTOVIR™. We look forward to advancing the associated clinical trials as efficiently as possible,” said Dr. Kim.
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