RPI-78M is a modified anticholinergic alpha-neurotoxin peptide
that was originally derived from an extract of cobra venom and is an antagonist
of the nicotinic acetylcholine receptor. It is expected that RPI-78M may be
beneficial in neuromuscular disorders where the activity of nicotinic
acetylcholine receptor has been compromised. RPI-78M is being developed for the
treatment of multiple sclerosis (MS). Other neurological disorders that may be
served by RPI-78M include myasthenia gravis (MG), muscular dystrophy (MD) and
amyotrophic lateral sclerosis (ALS).
Cobratoxin, a neurotoxin obtained from the venom of the Thailand
cobra, has demonstrated several pharmacological activities that strongly
support its use in this application. By employing a chemical detoxification
step, the neurotoxin was rendered safe for administration to humans with
minimal side effects. In a early reporet study, this modified neurotoxin demonstrated
neuromodulatory, antiviral, and analgesic activity, elements associated with
the multiple sclerosis condition. Modified cobratoxin demonstrated potent
immunosuppressive activity in acute and chronic animal models of the disease. Following
the positive signs, the drug was shortlisted for use in adrenomyeloneuropathy
and clinical trials in Multiple sclerosis were planned [1].
Salient Features about RPI-78M
a:
It lacks measurable toxicity. The binding with receptor is excellent suggesting
that patients cannot overdose.
b:
It has displayed no serious adverse side effects following years of
investigations in humans and animals.
c:
It extremely stable and resistant to heat, which gives the drugs a long shelf
life. The drugs' stability has been determined to be over 4 years at room
temperature. This is extremely unusual for a biologic drug.
d: RPI-78M can be administered orally-a first for a biologic MS drug. This will
present MS patients with additional quality of life benefits by eliminating the
requirement for routine injections.
On Sept 08, 2015 Nutra Pharma
Corporation announced today that they have received Orphan Drug designation
from the US-FDA for the Company's RPI-78M drug candidate for the treatment of
Multiple Sclerosis in children.
RPI-78M
induces interleukin 27 (IL27) and gamma-interferon, and it is in Phase III
testing for Adrenoleukodystrophy and for additional diseases such as multiple
sclerosis and herpes virus infection in earlier phases. IL27 has also been
associated with inflammatory bowel disease, including Crohn's disease. Moreover,
it has been shown that treatment with IL-27 reduces experimental colitis
through the suppression of several inflammatory cytokines including IL- 17. In
this situation, human genetic and animal studies converge to support
inflammatory bowel disease and Crohn's disease specifically as new indications
for RPI-78M [2].
References:
1. Reid,
P. F. Alpha-cobratoxin as a possible therapy for multiple sclerosis: a review
of the literature leading to its development for this application. Crit Rev
Immunol 2007, 27(4), 291-302.
2. Reid,
P. F.; et. al. Modified anticholinergic neurotoxins as modulators of the
autoimmune reaction. US8034777B2