10
BioTech Navigator, March 1998
52 Week Trading History
with oral antibiotics result in the healing
of 20-25% of the patients, with an inci-
dence of recurrence occurring as high as
50%. These infections are a significant
cause of extended hospitalization and
limb amputation.
Two pivotal phase III trials have been
conducted with Cytolex. Analysis of the
data showed statistical equivalence be-
tween Cytolex and Floxin, an antibiotic
indicated for the treatment of infection in
soft tissue and skin. Cytolex was ex-
tremely well tolerated and exhibited no
drug-related skin reactions. Importantly,
patients on Cytolex reported statistically
significant fewer incidences of insomnia,
a known side effect of Floxin. The stud-
ies demonstrated that a topical antibiotic
could prove equivalent to a potent oral
antibiotic, thus offering to physicians,
for the first time, the possibility of an
alternative to oral or injected (systemic)
therapy. This is particularly important to
diabetics, in whom infections are fre-
quent and for whom systemic side ef-
fects and increasing antibiotic resistance
are crucial issues.
Cytolex has several advantages over
Floxin for treating DFU. First, Cytolex
may be active against a broader spec-
trum of infectious agents, such anaerobic
bacteria and fungi, and Floxin resistant
organisms. Second, because it is topi-
Magainin Pharmaceuticals Inc.
The chemical structure of squalamine
uniquely combines a steroid and
polyamine, two classes of systemic
agents that are generally well tolerated
in humans. The company's second plat-
form technology is a gene-based target
and drug discovery program in asthma.
The company employs a broad range of
genomics techniques to identify genes
associated with the pathogenesis of
asthma, with the objective of utilizing
the optimal biologic gene argets in the
development of novel therapeutics for
asthma and allergy.
Valuation
Cytolex is a topical antibiotic cream
that is being developed for the treatment
of infection in diabetic foot ulcers
(DFU), a common and serious complica-
tion. Magainin estimates that approxi-
mately 600,000 individuals are treated
for DFU each year. Current treatments
Program Pipeline
Program
Indication
Status
Cytolex
Diabetic Foot Ulcers
Phase lll
Squalamine
Angiogenesis inhibitor for treament of tumors
Phase l
Interleukin-9
Asthma
R&D
Overview
Magainin Pharmaceuticals is a de-
velopmental stage biotechnology com-
pany who is focused on isolating and
developing compounds from the host-
defense systems of animals. Currently,
Magainin is developing potential thera-
peutic products targeting infections, on-
cology, pulmonary and allergic disor-
ders.
Technology
Magainin's biopharmaceutical re-
search and development efforts are fo-
cused on two technology platforms. The
host drug discovery program seeks to
isolate and develop therapeutically active
compounds from various animals, for the
treatment of human diseases. The host
defense system is how the body protects
itself against infections and certain can-
cer. The specific defenses range from
physical barriers to infection, such as
skin, to complex chemical and biologi-
cal components, such as those found in
the immune system. The company's
most advanced class of compounds un-
der development are magainin peptides,
a class of naturally occurring peptides
(small chains of amino acids) that can be
used to provide a first line of defense
against human infectious diseases.
These molecules act by puncturing the
membrane of the pathogen, resulting in
the death of the pathogen. Another com-
pound being developed is squalamine
(from the dogfish shark), a naturally oc-
curring steroid-like compound with an-
tiviral and anti-angiogenic properties
which may have multiple applications,
including the control of cell proliferation.
