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Human Genome Sciences, Inc., founded in 1992, is a pioneer in the use
of genomics, the study of all human genes, and the development of new
pharmaceutical products. We are a leader in moving these genomics-based
drugs into patient-based clinical trials.
Currently, we have six drugs in human clinical trials. Our goal is to
become a global pharmaceutical company that discovers, develops, manufactures
and sells our own genomics-based drugs.
Gene
and Protein Discovery Technology
We have created a broad set of integrated skills that allow us to discover
new genes and to understand their natural function. We have developed
methods to make small quantities of thousands of undiscovered proteins.
We isolated a virtually complete collection of human genes in their active,
messenger RNA form. We have developed highly automated systems to analyze
effects of the gene products on human cells and tissues.
Collectively, these
new and powerful methods make up our Functional Proteomics Program. Our
Functional Proteomics Program begins with a virtually complete set of
functional, fully sequenced human genes. From these we select a set, now
about 9,000 individual genes, that produce proteins that are located on
the outside of human cells. Such proteins are called secretory proteins.
Each of the secretory protein genes encodes a different functional protein.
We test the effects of the secretory proteins by placing each of them
on an individual culture of a human cell whose behavior we wish to change
for medical benefit. We use highly automated techniques that we have developed
for this purpose. In the course of these experiments we monitor many parameters
of change of each cell culture at intervals. We have developed a sophisticated
informatics system to store and interrogate the many millions of biological
data points that result from these experiments. Proteins selected for
further study are made and purified, then subjected to preclinical evaluation.
Repifermin
Repifermin (Keratinocyte Growth Factor-2, KGF-2) is a novel human protein
that stimulates the repair of skin and mucosal tissues. This drug stems
from our early genomic discoveries.
An estimated 500,000 to 700,000 patients in the United States suffer from
a persistent type of skin lesion called a venous ulcer. The first complete
phase 2 clinical trial of Repifermin was recently reported by Robson and
colleagues in a study on patients with venous leg ulceration [Robson,
2001]. This was a multicentre (15 sites) investigation carried out over
12 weeks on 94 patients. Topical Repifermin delivered by spray application
resulted in accelerated healing in patients treated with Repifermin. The
positive results from this trial were presented at the World Wound Healing
Congress in September 2000.
In addition, a Phase
2B clinical trial (70 sites; 700 patients) is in progress to determine
the outcome on complete healing at 26 weeks for patients with venous ulcers.
Repifermin is also in Phase 2 clinical trials at sites throughout the
United States to test its ability to prevent mucositis and debilitating
sores in the mouth, throat and gastroin-testinal tract, in patients undergoing
chemotherapy with bone marrow transplantation.
We are also evaluating Repifermin for the treatment of patients with ulcerative
colitis, a common form of inflammatory bowel disease. We are pleased that
our partner SmithKline Beecham (now GlaxoSmithKline) will join us developing
and marketing Repifermin, starting with Phase 3 trials.
During 1999 we focused on strengthening and enhancing the management team
of our clinical development function. We are pleased that David C. Stump,
M.D., joined us as Senior Vice President, Drug Development, and a member
of the Operating Committee. Dr Stump joined us from Genentech, Inc., where
he was responsible for directing their clinical development activities.
Further information
may be obtained from the website: http://www.hgsi.com/
Human Genome Sciences
9410 Key West Avenue
Rockville, MD 208850-3338
USA
Tel: 001 301 309 8504
Fax: 001 301 309 8512
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