US EditionLife Bio receives FDA approval for ER-100 clinical trial
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As billionaires chase immortality, this startup cofounded by a Harvard genetics professor gets FDA approval for the first partial de-aging human trial
A startup cofounded by a renowned Harvard geneticist has taken a step toward cracking the human body’s biological breakdown by securing FDA approval to test its cutting-edge gene therapy on humans. Life Biosciences, a biotech company cofounded by Harvard genetics professor David Sinclair, said Wednesday it had secured approval for a Phase 1 clinical trial aiming, in part, to restore vision in people with eye conditions such as glaucoma and non-a…
Life Bio receives FDA approval for ER-100 clinical trial
Life Bio has received the US FDA approval for its IND application, allowing it to begin a clinical trial of ER-100 for optic neuropathies.The post Life Bio receives FDA approval for ER-100 clinical trial appeared first on Clinical Trials Arena.
The biotechnological strategy behind the ER-100 treatment is based on the introduction of so-called Yamanaka factors, reprogramming genes that can induce a specialized cell to revert to a stem cell state, functioning as a cellular "factory reset." In this first clinical phase, a dozen volunteers will receive an injection of a virus carrying three of these genes in one of their eyes. The genetic control of this process is extremely precise: activ…
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