Voyager Therapeutics Inc (NASDAQ: VYGR) saw its shares progress Tuesday, after the company reported the FDA clearance of Investigational New Drug application for VY-AADC for advanced Parkinson's disease.
The Cambridge, Mass.-based company reported Tuesday the IND nod VY-AADC would allow the Company to initiate formally clinical trial sites, screen and begin dosing patients for its pivotal Phase 2-3 program for advanced Parkinson’s disease.
A release said that, ss part of this IND, the chemistry, manufacturing, and controls section included data demonstrating comparability between VY-AADC produced under good manufacturing practice (GMP) using Voyager’s baculovirus/Sf9 manufacturing process and VY-AADC produced using a mammalian cell system consisting of triple-transfection of human embryonic kidney (HEK293) cells.
Voyager Chief Medical Officer Bernard Ravina was quoted in the release as saying, "our baculovirus manufacturing process is designed for production of AAV vectors at clinical and commercial scale, with the potential for increased yields and efficient scaleability compared with mammalian-based systems.
"Having demonstrated comparability between the baculovirus and mammalian-based VY-AADC, we are pleased to initiate our pivotal program and begin dosing patients with the baculovirus-produced vector.
Following institutional review board approval and patient screening at clinical referral and surgical sites, we continue to plan to dose the first patient in our pivotal program during the second quarter of this year, representing a very important milestone for both the program and the company."
Voyager shares approached noon ET Tuesday up $1.03, or 5.1%, to $21.26.
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