Post by
Red~One on Mar 30, 2022 3:49pm
RE:PHASE 1
Phase 1
The last and only time nitric oxide was approved (to treat newborn babies with respiratory failure) was in 1998 and that was to act as a smooth muscle relaxant (widen blood vessels in the lungs). Since 1998 there has been no approval for NO to treat a disease until this year. One Canadian company has done it, and no it is not CLAS..
Phase I studies of a new drug are usually the first that involve people. Phase I studies are done to find the highest dose of the new treatment that can be given safely without causing severe side effects.
Nitric Oxide is already known to have certain antimicrobial and health uses.
The problem, until now, has been how to administer it safely and cheaply.
Delivery systems using inhalation and other delivery mechanisms such as injection, inhalation and oral medication are now being developed.
The trick is to deliver the correct dose to the proper site with no neural or cellular toxicity. (cytotoxicity) Another issue is how to control the Nitric Oxide when it comes across a superoxide in the body and creates Peroxynitrite which can cause oxidative damage to biological tissues.
Salzman claims that R107 is safe and can be delivered effectively.
Other N.O. carriers are being developed to achieve this and that safe and accurate dosing is going to be key in Phase 1 clinical trials.
Comment by
PTBailey on Mar 30, 2022 3:56pm
Good post. And hopefully Salzmans claims will be proven right very soon when phase 1 begins.