4
tremely important products, there are
alternatives, especially for smaller
lesions where grafts aren't needed.
This is an area being evaluated by
several biotech companies, including
Genzyme Biosurgery. Genzyme, and
OSI Pharmaceuticals are both
evaluating Transforming Growth Fac-
tor Beta 3 (TGF-ß3) for chronic
wound healing in Phase II clinical
trials. TGF-ß3 functions to attract
specific cell types involved in wound
healing and stimulate their cell
growth. This should be a valuable
therapeutic compound, and
BSR is
excited about its prospects for facili-
tating the healing of chronic wounds.
If both companies progress further in
clinical trials, OSI Pharmaceuticals
may have a slight advantage, as they
are partnered with Novartis to de-
velop the compound.
Genomic giant
Human Genome
Sciences is making the move into
therapeutics, by developing Repifer-
min. Repifermin, also known as Ke-
ratinocyte Growth Factor-2, is a hu-
man protein that promotes the growth
and repair of epithelial cells, which
make up almost one-third of all hu-
man body cells. Though best known
as the major cell type in the skin,
epithelial cells also make up the mu-
cosal tissues that line the mouth,
throat, gastrointestinal tract and sev-
eral other organs, as well as hair cells/
follicles. Laboratory studies in models
of human disease demonstrate that
Repifermin can be used to repair dam-
age to both the dermal and epidermal
layers of skin. Human Genome Sci-
ences is currently in Phase II clinical
trials to evaluate Repifermin as a
treatment of venous ulcers. Venous
ulcers are lesions on the skin of the
ankle or lower leg caused by chronic
venous insufficiency and require many
months to heal, if they heal at all.
BSR
thinks highly about Human Genome
Sciences and is encouraged that they
are moving into the biological product
arena. Repifermin should move well
in clinical trials and we anticipate that
it will someday be approved for this
indication as well as others.
Scios is another biotech that is
developing a recombinant Fibroblast
Growth Factor (FGF, Fiblast) for
wound healing. Scios has licensed
FGF to Kaken Pharmaceutical Co.,
Ltd., of Japan, for development in
Japan, China, Taiwan and South Ko-
rea. Kaken has initially investigated
the use of FGF as a wound-healing
treatment and has filed an NDA in
Japan seeking approval to market
FGF in this indication. A determina-
tion on Kaken's NDA is expected
soon. Scios also has licensed rights to
Orquest, on a nonexclusive basis, for
treatment of bones, cartilage, or liga-
ments; and to Selective Genetics,
rights relating to FGF's use as a pro-
tein fusion partner or conjugate for
delivering other pharmaceutical
agents. If FGF receives approval in
Asia for wound healing, expect Scios
and its U.S. partner Chiron to expand
its use for treating wounds here.
Injuries to the Knee
Another injury/healing area
which biotechnology will play a sig-
nificant role in improving patient
quality of life is sports-related inju-
ries. I can speak to this area person-
ally, not that I am an athlete or a
weekend warrior, but because I in-
jured both knees in high school play-
ing basketball and can feel the effects
of those injuries and surgeries more
each year. I don't think I'm alone ei-
ther, as more than two million Ameri-
cans injure their knees (cartilage, liga-
ment, tendon or bone) and may un-
dergo some type of surgery each year.
Whatever the cause of this trauma, the
result is the same: pain that makes it
difficult or impossible to lead the ac-
tive life we all enjoy, especially baby
boomers, who feel they need to be
active to deny they're getting older or
to ward off the effects of aging.
Many individuals, like myself,
live with some degree of pain for
years. Simple activities like kicking
the soccer ball with your child or get-
ting in and out of the car can become
an ordeal. And despite what some
physicians say, change in weather and
BioTech Sage Report, January 2001
