Products Under Development:
hgsi.com
Human Genome Sciences has a strong pipeline of drugs in human trials. We have four drugs in current human trials. These include the first of our genomic drugs. The nature of our first products, human proteins, reflects our core competency in the design and development of protein drugs.
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. Positive data from a human Phase IIa trial of repifermin were presented in September 2000 at the World Wound Healing Congress. A large-scale clinical trial of repifermin for treatment of venous ulcers began in March 2001.
Repifermin is in Phase II clinical trials at sites throughout the United States to test its ability to prevent mucositis—debilitating sores in the mouth, throat and gastrointestinal 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 III trials.
B LYMPHOCYTE STIMULATOR
B Lymphocyte Stimulator (BLyS ™) is a protein made by the human body that stimulates the production of natural antibodies. Antibodies recognize foreign substances and help defend against infection by viruses, bacteria and other microorganisms.
We are conducting a Phase I clinical trial of BLyS in patients with Common Variable Immunodeficiency, a serious defect of the immune system. Patients with Common Variable Immunodeficiency are unable to make adequate amounts of their own antibodies and suffer from increased susceptibility to infections. BLyS may restore the ability of these patients to produce antibodies, an important advance in their treatment.
If BLyS is found to be safe, we plan to conduct future clinical trials of BLyS in patients with common diseases such as cancer, AIDS, age-related immunodeficiency and antibiotic-resistant infections.
Human Genome Sciences has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for the use of BLyS for the treatment of Common Variable Immunodeficiency. Orphan drug status can both facilitate the development and protect the future market of BLyS.
MIROSTIPEN
Mirostipen (Myeloid Progenitor Inhibitory Factor-1, MPIF-1) is a human protein that protects the blood-forming tissues and the immune system from damage caused by cancer therapies.
Cancer drugs often damage the blood-forming tissues because they kill healthy cells that are rapidly dividing, as well as cancerous cells. The damage leaves patients vulnerable to life-threatening infections. Laboratory studies show that mirostipen can shield blood-forming cells.
Mirostipen is the subject of two Phase II clinical trials for breast and lung cancers.
ALBUFERON™
Albuferon (albumin-interferon alpha) is our newest drug to enter clinical trials and the first to use albumin-fusion protein stabilization technology. The drug is made by fusing the gene for human albumin to that for interferon alpha. The fused genes then give rise to Albuferon.
Albuferon will initially be evaluated in the treatment of hepatitis C, a viral inflammation of the liver that kills 8,000 to 10,000 people per year in the United States. Albuferon may improve patient benefit by providing a sustained source of interferon in the body, reducing side effects and the need for frequent injections. If Albuferon is proved safe, we plan to initiate clinical development of the drug for patients with cancer. |
