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The development of an oral form of insulin is a challenge
that has tested the scientific powers of the pharmaceutical
industry for many years. The problem lies in the fact that
the digestive system metabolises insulin before it can reach
the tissues. Even so, many companies have decided to look
for an oral form of insulin as this will help boost compliance
and reduce complications. The need for daily injections
is a major problem in diabetes and companies that produce
an easy-to-use alternative will be likely to benefit considerably,
especially as the incidence of diabetes is rising year-on-year.
The
company that seems to be most advanced in this area is Canada’s
Generex Biotechnology, which is conducting Phase II clinical
trials with Oralin. This is administered as a fine
spray into the mouth using a hand-held aerosol. The insulin
then passes into the bloodstream for distribution to the
tissues. For patients this means an end to inconvenient
injections and the avoidance of complications caused by
multiple jabs. The studies conducted so far have shown that
this route of administration is effective and provides a
similar level of control as injected insulin. Generex has
just commenced dosing trials in 60-80 diabetics, with a
long-term safety and efficacy trial due to begin in up to
100 patients by October 1999. Oralin could be launched in
2001.
The
UK biotechnology company Cortecs is also developing an oral
form of insulin called Macrulin. This is in Phase
II trials in Type II diabetics and has already been shown
to deliver biologically active insulin through intestinal
absorption.
Meanwhile,
the US company Protein Delivery has just produced ‘proof
of principle’ data for its oral insulin product, called
M2. This is a modified form of insulin that can effect
glucose control. Protein Delivery is now looking for partners
to help with the further development of its product, which
could be marketed by 2002.
Another
oral form of insulin is being developed by the Irish drug
delivery specialist Elan - this is in Phase I trials. Endorex
also has a preclinical product available for licensing,
and, obviously hedging its bets, Eli Lilly is conducting
Phase II trials on the oral agent AI-401, developed
by US company AutoImmune.
Details
on the development of oral insulins can be found on IMS
HEALTH’s drug development database R&Dfocus.
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