CytoDyn, Inc. has sent the FDA what the Company
believes is a complete response to the agency's preliminary comments on
Cytolin, a monoclonal antibody designed to restore immune function in
those afflicted with HIV/AIDS.
As one example of how this process works, the FDA asked CytoDyn to
conduct a laboratory experiment to quantify the effect of Cytolin on
HIV. In its response, the Company explained that an immune modulator
cannot have a direct effect on a virus making what the FDA requested a
scientific impossibility. Rather, the reduction in HIV levels
consistently observed in patients treated with Cytolin is due to
improved functioning of the immune system, as confirmed by a restored
ability of patients treated with Cytolin to recognize five germs to
which most adults have been previously exposed. This effect is studied
by injecting a small quantity of dead germs just under the skin and is
referred to as a resolution (cure) of cutaneous (skin related) anergy
(lack of immunologic activity). It was first observed in the earliest
human study of Cytolin, a small pilot study conducted by AIDS reSEARCH
ALLIANCE in 1995 and subsequently reported in the peer-review
literature.
As another example, the FDA expressed a concern that Cytolin - which
reduces HIV levels indirectly by strengthening the immune system, might
suppress the immune system and exacerbate infections. Precisely because
this concern is nonsensical, it underscores the impact of the criticism
that was directed at the FDA after the approval of Raptiva, an antibody
designed to be the opposite of Cytolin and to suppress the immune
system as a treatment for moderate to severe plaque psoriasis, a
disease caused by a hyperactive immune system and characterized by
rash, fever, chills, and severe itching. Raptiva is the registered
trademark of Genentech. In other words, it is as if the FDA had been
criticized for allowing a company to pour water on a fire that was out
of control after some patients alleged this had left them susceptible
to infections. The FDA is now concerned that pouring gasoline on a fire
weakened by HIV will do the same thing as water because the agency
lacks the expertise to distinguish between two very different fluids.