Recently, Genentech presented data at the American Neurologist
Association Meeting in Miami Florida of the results of a phase II
diabetic neuropathy study that demonstrated there was significant
inprovement in response to heat and cold. What this means is that Nerve
Growth Factor has an effect on small fiber neurons in stead of large
fiber neuorns, and this is significant since HIV associated peripheral
neuropathy is primarily a small fiber neuropathy. There was also an
overall reduction in pain as measured by "accepted pain scales." The
results have motivated Genentech to move ahead with a 1600 patient
phase III study and to use this to go for approval. Hence there are
many folk with Diabetic Neuropathy athat live longer than PWA’s, that
is where the big money is.
ACTG#291 is a phase II study of rhNGF v/s placebo for HIV associated
Peripheral Neuropathy. Participants can take any adjuctive treatment to
control pain. Unfortunately, Genentech has not made a commitment to
trial participants to recieve study drug at all following the study.
ACT UP Golden Gate will be meeting with Genentech very soon. We would
like to hear from PWA’s that have neuropathy and are interested in
receiving rhNGF. Your testimonies will be critical in convincing
Genentech to do the ethical thing and supply study drug to
participants, if they choose, when their regamin is completed.
Currently, there is no commitment to ever give trial participants NGF
after the study.
NGF is the only drug that has the potential to repair damaged nerves or
protect them. Hence this study is the most important peripheral
neuropathy trial in the history of HIV.
Please call 415 502 7525 or e mail Matt_Chapp…@out.org with comments.
Matthew Chappell, CCG rep to the ACTG Neurology Committee and member of
ACT UP Golden Gate.