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Human Genome Sciences Initiates Phase II Human ClinicalTrials Of KGF-2, a New Wound-Healing Drug
Third HGSI Drug Candidate Enters Efficacy Studies
ROCKVILLE, Md., Feb. 10 /PRNewswire/ -- Human Genome Sciences, Inc. (Nasdaq: HGSI) announced today that it has initiated of Phase II human clinical studies of its genomics-derived therapeutic protein drug, Keratinocyte Growth Factor-2 (KGF-2).
"HGSI now has three novel drug candidates in human clinical efficacy studies. These three drug candidates began clinical testing in 1998 and are proceeding at a rapid pace," said William A. Haseltine, Ph.D., Chairman and Chief Executive Officer of HGSI. "It is our hope that the genomics drug- discovery paradigm pioneered by HGSI will provide a large number of drugs to solve the unmet medical needs of many patient populations."
The KGF-2 Phase II human clinical studies are designed to evaluate its safety and effectiveness as a topical would healing treatment for venous ulcers. These double-blind and placebo-controlled studies are being conducted at several leading medical centers in the US and will help to identify appropriate doses and regimens for future studies. HGSI also plans to conduct additional Phase II clinical studies for other topical indications for this novel therapeutic protein product. In addition, KGF-2 has completed successful Phase I studies to evaluate its safety as a systemically administered treatment. Phase II efficacy studies under this separate IND will be pursued during 1999.
In the U.S., an estimated 500,000 patients experience venous ulcers each year. Venous ulcers are lesions on the skin of the ankle or lower leg caused by chronic venous insufficiency. This leads to pooling of blood in the extremities, causing swelling, or edema, and mild redness and scaling of the skin, often over a varicose vein. Ulceration gradually develops as the skin becomes inflamed. The current therapy for these wounds is most often debridement, compression and management of infection. Current treatment for venous ulcers often extends for several months and frequently ends without success.
Phase I human clinical studies found that topically applied KGF-2 was safe and well tolerated in healthy human subjects at doses above those proposed for subsequent clinical studies. None of the subjects withdrew from the study or required dose modification because of adverse effects. Earlier, in pre- clinical in vivo studies, KGF-2 demonstrated beneficial effects on both the dermal and epidermal tissues of the skin, healing full-thickness wounds in a short period of time.
With the start of these Phase II clinical studies of KGF-2, HGSI now has three novel drugs undergoing efficacy testing in its company-sponsored clinical development program. In November 1998, Myeloid Progenitor Inhibitory Factor-1, or MPIF-1, began Phase II human clinical studies for the protection of hematopoietic progenitor cells against the effects of chemotherapeutic agents. In December 1998, HGSI's joint venture company, Vascular Genetics Inc., initiated Phase I/II human clinical studies of its gene therapy product, gtVEGF-2, for angiogenesis in critical limb ischemia. In a planned expansion of its clinical development program, HGSI anticipates filing for permission, during 1999, to bring additional novel drug candidates forward to human clinical testing.
KGF-2 is a newly discovered growth factor discovered by HGSI through its genomics drug-discovery paradigm. It was identified through a systematic review of thousands of full-length genes. Many of these genes have been expressed in recombinant form and have been tested in more than 70 cell-based screening assays. HGSI scientists discovered what they believe are 40 new members of the fibroblast growth factor family by using high throughput sequencing, high throughput biological screening and proprietary bioinformatics software to assist in identifying potential medical uses for these novel genes.
Human Genome Sciences is a company with the mission to develop products to predict, prevent, detect, treat and cure disease based on its leadership in the discovery and understanding of human and microbial genes.
HGS and Human Genome Sciences are registered trademarks of Human Genome Sciences, Inc. For additional information on Human Genome Sciences, Inc., visit the Company's Web site at www.hgsi.com. Copies of HGSI's press releases are also available by fax 24 hours a day at no charge by calling 800/758-5804, ext. 121115.
Any statements released by Human Genome Sciences, Inc. that are forward looking are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Readers are cautioned that forward- looking statements involve risks and uncertainties which may affect the Company's business prospects and performance. These include economic, competitive, governmental, technological and other factors discussed in the company's filings with the Securities and Exchange Commission on forms 10-K and 10-Q.
BACKGROUNDER
Keratinocyte Growth Factor - 2 (KGF-2):
A Novel Wound-Healing Therapy
Keratinocyte Growth Factor - 2 (KGF-2) is a newly discovered human protein. HGSI scientists believe that KGF-2 is always present in humans, and is activated only when there is an epithelial tissue wound. It may work by attracting fibroblasts, collagen and connective tissues to the site of the wound to heal it through the creation of new tissue. In skin, KGF-2 causes the creation of new dermal and epidermal tissue, healing full-thickness wounds in a short period of time with little scarring.
Wound-Healing and Venous Ulcers
Epithelial cells make up almost one-third of all the human body's cells. Though best known as the major cell type in the skin, they also make up the lining of the mouth, throat, gastrointestinal tract and several other organs as well as hair cells/follicles. Topical epithelial cell injury can take many forms, including ulcers, cuts, abrasions, and burns. These topical wounds heal over varying lengths of time, ranging from several days for acute surgical wounds to many months, if at all, for chronic wounds such as venous ulcers and pressure ulcers. Healing rates can also be affected by concomitant disease, such as diabetes and peripheral vascular disease.
In general, a chronic wound of the skin is a disruption of the integrity of the skin, which does not heal within an expected time frame. They may linger for weeks, months or years. The causes of such wounds may be structural, such as an injury, or physiological, such as an underlying disease. Overall poor health and nutrition prevent or delay normal healing of wounds in compromised patients.
There are four stages of chronic wounds. Stage 1 wounds involve no break in the skin and are currently treated with conservative measures such as pressure relief. Stage 2 and 3 wounds are partial and full-thickness wounds, respectively, reflecting the depth of the wound. These represent the largest category of chronic wound patients and the areas of greatest unmet need. Stage 4 patients have wounds that extend into muscle, tendon or bone. These patients are at significant risk of sepsis and typically are treated with surgery.
In the U.S., an estimated 500,000 patients experience venous ulcers each year. Venous ulcers are lesions on the skin of the ankle or lower leg caused by chronic venous insufficiency. This leads to pooling of blood in the extremities, causing swelling, or edema, and mild redness and scaling of the skin, often over a varicose vein. Ulceration gradually develops as the skin becomes inflamed. The current therapy for these wounds calls for debridement of necrotic tissue, cleaning, compression therapy, application of topical emollients, dressing and topical steroids, management of infection. In severe cases, surgery may be necessary. Current treatment for venous ulcers often extends for several months and frequently ends without success.
HGSI's KGF-2 Development Program
KGF-2 is one of many potential therapeutic products that have been discovered, based on HGSI's genome technology. This protein was identified through a systematic review of thousands of full-length genes corresponding to what HGSI scientists believed to be potential therapeutic protein candidates. Many of these have been expressed in recombinant form and have been tested in more than 70 cell-based screening assays. HGSI scientists discovered what they believe are 40 new members of the fibroblast growth factor family by using high throughput sequencing, high throughput biological screening and proprietary bioinformatics software to assist in identifying potential medical uses for these novel genes.
In addition to the Company's own products, HGSI also stands to benefit substantially from products developed by its broad network of corporate partners. The Company has formed a human gene consortium whose partners include Schering-Plough Corporation, SmithKline Beecham, Ltd., Merck KGaA, Takeda Chemical Industries and Synthelabo, S.A. HGSI receives licensing fees, research and development payments from these consortium partners and is entitled to receive milestone and royalty payments on the development and sale of their products. HGSI holds the gene-therapy and anti-sense rights to all of the genes it discovers. The Company also has formed three alliances to develop and commercialize gene-therapy products with Schering-Plough, Transgene S.A. and Vascular Genetics Inc. HGSI receives licensing fees and milestone payments from Schering-Plough and Transgene and is entitled to royalties or marketing rights for selected products from these partners. In addition, HGSI collaborates on its microbial gene discoveries with F. Hoffman- LaRoche, Ltd., Pharmacia & Upjohn Company, Pasteur Merieux Connaught/Oravax, MedImmune, Inc. and Affymetrix, Inc. Each of these companies uses HGSI technology to develop independent products of its own, for which HGSI will receive some combination of milestone and royalty payments.
Human Genome Sciences is a company with the mission to develop products to predict, prevent, detect, treat and cure disease based on its leadership in the discovery and understanding of human and microbial genes.
For additional information on Human Genome Sciences, Inc., visit the Company's Web site at www.hgsi.com. Copies of HGSI's press releases are also available by fax 24 hours a day at no charge by calling 800-758-5804, ext. 121115.
Any statements released by Human Genome Sciences, Inc. that are forward looking are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Readers are cautioned that forward- looking statements involve risks and uncertainties which may affect the Company's business prospects and performance. These include economic, competitive, governmental, technological and other factors discussed in the company's filings with the Securities and Exchange Commission on forms 10-K and 10-Q.
SOURCE Human Genome Sciences, Inc.
CO: Human Genome Sciences, Inc.
ST: Maryland
IN: HEA
SU: PDT
02/10/99 07:30 EST prnewswire.com
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