Ill.--(BUSINESS WIRE)--June 1, 2004--BioSante Pharmaceuticals,
Inc. (Amex:BPA) announced today the publication of
positive results of a preclinical study of its proprietary
calcium phosphate nanoparticle (CAP) delivery system
for the oral delivery of insulin in the June 11 issue
of the peer-reviewed International Journal of Pharmaceutics.
The results of this study add to the mounting evidence
that our unique technology may represent a major advance
in the development of an easy, pain-free alternative
to currently injected products such as insulin for
diabetics, allowing them to live a more comfortable
life," said Dr. Tulin Morcol, associate director
of drug delivery and related technologies for BioSante.
"The study results show that our CAP formulation
has the potential to overcome the considerable obstacles
to effective oral delivery of insulin and other currently
injected therapeutic proteins."
The published study evaluated the use of BioSante's
BioOral(TM) drug delivery system to administer insulin
orally. The oral formulation was developed by aggregating
caseins (the principle protein in milk) around a proprietary
formulation of CAP, polyethylene glycol (PEG, a polymer)
and insulin by scientists at BioSante's research center
in Smyrna, Georgia. The therapeutic efficacy of the
formulation, known as CAPIC(TM), was tested in diabetic
mice that were either fasted or fed prior to the experiments.
A single dose of CAPIC was administered via the oral
route into the stomachs of the mice, while control
groups were given insulin alone, either by subcutaneous
injection or via the oral route into the stomach.
Blood glucose levels were then monitored every one
to two hours for 12 hours.
CAPIC reduced the blood glucose levels of fasted diabetic
mice by 80 percent within the first hour and maintained
the reduction for 12 hours. In contrast, insulin alone
(without CAP) only reduced blood glucose about 20
percent and only for four to five hours. The glucose-reducing
effect of CAPIC was comparable to the levels in the
subcutaneously injected controls; however, CAPIC reduced
glucose for 12 hours versus only about five hours
for insulin alone.
In fed mice, CAPIC induced a 50 percent reduction
of blood glucose levels within three hours, and glucose
returned to previous levels after five hours. In contrast,
an identical dose of insulin alone had no effect on
glucose levels in fed mice controls. These important
results suggest that there may also be a postprandial
application for CAPIC.
"The acidic environment of the stomach would
normally break down native insulin before it can be
absorbed into the bloodstream," said Dr. Morcol.
"Our proprietary formulation, with the casein
coating around the CAP-insulin core, appears to protect
the insulin as it passes through the stomach to reach
the small intestines intact and in a functionally
Dr. Morcol added that the study results as well as
other studies using CAP indicate that CAP also could
be used to preserve the functional ability of other
therapeutic proteins or peptides for oral administration.
"The results of this study further strengthen
our belief that the use of CAP offers great potential
to become an important new treatment option for diabetics
and others who currently use injectable therapies,"
said Stephen M. Simes, president and chief executive
officer of BioSante. "We plan to conduct further
studies internally as well as to continue our work
with other companies with insulin and other protein
and peptide formulations."
BioOral is an oral delivery system using BioSante's
CAP nanotechnology -- microscopic particles of calcium
phosphate similar to that found in teeth and bones.
The patented formulation is nontoxic and biodegradable,
offering a multitude of potential medical applications.
abstract of the study is available on the journal's
Web site at http://www.sciencedirect.com/science/journal/03785173.
About BioSante Pharmaceuticals, Inc.
BioSante is developing a pipeline of hormone therapy
products to treat both men and women. The company
also is developing its calcium phosphate nanotechnology
(CAP) for novel vaccines, including biodefense vaccines
such as anthrax and ricin, and drug delivery systems.
More information is available online at www.biosantepharma.com.