VGX Pharmaceuticals has submitted an investigational new drug application to the FDA for Phase I clinical studies of VGX-3200 in late stage cancer patients.
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The proposed human studies with plasmid-delivered Growth Hormone Releasing Hormone (GHRH) follow successful studies in dogs with cancer. Administration of GHRH plasmid with VGX’s Cellectra electroporation device was shown to increase IGF-I levels, ameliorate cachexia, improve anemia, prolong survival, and improve quality of life in dogs with cancer.
VGX-3200 is an injectable DNA plasmid-based therapeutic that expresses GHRH protein. Treatment for cancer-related cachexia and anemia is the first target for VGX-3200. Additionally, the company is developing the GHRH technology for a number of other indications including age-related disorders.
Joseph Kim, president and CEO of VGX, said: “We plan to file two additional INDs for our SynCon product candidates during the first two quarters of 2008: VGX-3100, a therapeutic vaccine for the treatment of cervical cancer and VGX-3400, a pandemic avian flu vaccine.”
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