Genesys Pharma has received approval from Canada's Health ProtectionBranch to begin a Phase I clinical trial with GPI-2A, its antisense drug for the treatment of HIV.
GPI-2A is a 20-mer oligonucleotide whose sequence is complementary to part of the p24 region of the HIV-mRNA. Once GPI-2A binds to the target, it inhibits production of the p24 protein, thus preventing the virus from replicating.
In preclinical studies, GPI-2A has been shown to be specific and potent inhibitor of HIV. It is able to accumulate in brain cells "at good concentrations," says the company, which may give it some advantages over other therapies which are unable to attack this HIV reservoir. Furthermore, its specificity to the p24 mRNA significantly minimizes the risk of side effects; in animals treated with 100 times the human dose, no side effects were observed. The company adds that the development of resistance to this drug "seems unlikely."
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