Selecta Biosciences has started the Phase 1 clinical study for the evaluation of pharmacodynamic profile, tolerability and safety of its nicotine nanoparticle vaccine candidate called SEL-068 for relapse prevention and smoking cessation.
The SEL-068 is Selecta Biosciences’ first vaccine from its in-house synthetic vaccine particle (SVP) technology to be clinically studied and is likely to become the first synthetically engineered vaccine.
The SEL-068’s Phase 1 clinical trial was conducted with health smoking and non-smoking volunteers and is a double-blind, rising-dose and placebo-controlled evaluation. Besides evaluating safety profile, the trial will assess the potency of the vaccine by measuring the levels of nicotine-specific antibodies. Selecta hopes to report preliminary findings of the Phase 1 study during the first half of 2012.
Since the SEL-068 is completely synthetic, the immune reaction is fully concentrated on nicotine and eliminates off-target reactions to biological carriers that normally happened with other vaccine techniques, enabling the SEL-068 to increase the antibody level for efficient nicotine absorption, which in turn stops addictive response by preventing nicotine’s entry to the brain. The U.S. National Institutes of Health’s institute, the National Institute of Drug Abuse has granted a part of the fund for the SEL-068 development program of Selecta Biosciences.
Ulrich von Andrian, Co-founder of Selecta Biosciences, stated that this is the first-of-its-kind completely integrated, nanoparticle-based synthetic vaccine and is being investigated in human clinical studies, marking a key landmark in the development of the company’s SVP platform. The President and Chief Executive Officer at Selecta Biosciences stated that the company is happy with the pre-clinical findings of its SVP technology and believes that the SEL-068 will fulfill the requisites of a relapse prevention and smoking cessation vaccine.
Source: http://www.selectabio.com