Human Genome Sciences Updates Progress of Six Drugs in Clinical Trials at JP Conference

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Human Genome Sciences Updates Progress of Six Drugs in Clinical Trials at

JP Conference

Monday January 12, 7:45 am ET

# ROCKVILLE, Md., Jan. 12 /PRNewswire-FirstCall/ -- Human Genome Sciences,

Inc. (Nasdaq: HGSI - News) on Wednesday will report on the progress of six

of its products in clinical development during a presentation to financial

analysts and investors at the 22nd Annual JP Healthcare Conference in

San Francisco.(Logo: http://www.newscom.com/cgi-bin/prnh/20010612/HGSLOGO )

Human Genome Sciences has a robust pipeline of gene-based drugs in mid-

stage clinical development, including novel human protein and human antibody

drugs, and long-acting human proteins. The Company's partners are developing

additional drugs based on its genomics-based technology. Human Genome

Sciences' focus in 2004 will be to advance clinical trials in two main

therapeutic areas: immunology/infectious disease and oncology.

During its January 14, 2004 presentation to the JP Conference, Human

Genome Sciences will provide updates on the following products in its

clinical development pipeline:

Immunology/Infectious Disease

LymphoStat-B: Human Genome Sciences is developing LymphoStat-B, a human

monoclonal antibody to B-lymphocyte stimulator (BLyS), as a potential

treatment for patients with autoimmune diseases, such as systemic lupus

erythematosus and rheumatoid arthritis.

Human Genome Sciences announced on Thursday, January 8, 2004 that it has

begun enrolling and dosing patients in a double-blind, placebo-controlled,

multi-center Phase 2 clinical trial that will evaluate the safety, optimal

dosing, and efficacy of LymphoStat-B in patients with rheumatoid

arthritis.(1) Approximately 230 patients with active rheumatoid arthritis

who have failed prior therapy will be enrolled in the trial and randomized

to receive intravenously 1 mg/kg, 4 mg/kg, or 10 mg/kg of LymphoStat-B or

placebo every four weeks over a 24-week treatment period. Efficacy will be

evaluated in the trial according to the American College of Rheumatology

(ACR) criteria for defining clinical improvement in rheumatoid arthritis

patients. The primary efficacy endpoint for the Phase 2 trial in rheumatoid

arthritis will be the rate of response at week 24 (i.e., the percentage of

patients who achieve at least 20% improvement on the ACR-specified measures

of disease activity).

Human Genome Sciences is currently enrolling and dosing patients in a

double-blind, placebo-controlled, multi-center Phase 2 clinical trial

designed to evaluate the safety, optimal dosing, and efficacy of

LymphoStat-B in patients with active systemic lupus erythematosus.(2)

Patients will receive multiple doses of LymphoStat-B or placebo over a

52-week treatment period. Efficacy will be measured in the trial according

to scores on the SELENA SLEDAI (Systemic Lupus Erythematosus Disease

Activity Index) and BILAG (British Isles Lupus Activity Group) disease

activity scales. Time to first lupus disease flare also will be recorded.

LymphoStat-B has received a Fast Track Product designation from the U.S.

Food and Drug Administration (FDA) for its potential use in treating

systemic lupus erythematosus.(3)

Human Genome Sciences plans to complete the enrollment of both Phase 2

clinical trials of LymphoStat-B in 2004.

Albuferon: Human Genome Sciences is developing Albuferon, a novel

long-acting form of recombinant interferon alpha, as a treatment for chronic

hepatitis C.

Interim results of an ongoing Phase 1/2 clinical study of Albuferon were

presented at the 54th Annual Meeting of the American Association for the

Study of Liver Diseases (AASLD) in November 2003.(4) Interim data

demonstrate that Albuferon is well tolerated, has a prolonged half-life and

is biologically active in patients with chronic hepatitis C who have failed

previous interferon-alpha treatments. The Company is continuing to evaluate

Albuferon at higher doses, in single-dose and repeat-dose cohorts, under an

amended protocol designed to seek the maximum biological response that can

be achieved at a tolerable dose.

Human Genome Sciences expects in 2004 to complete the ongoing Phase 1/2

clinical trial of Albuferon, and to complete enrollment for a Phase 2

clinical trial of Albuferon in patients with chronic hepatitis C who are

naive to treatment with interferon-alpha.

ABthrax: ABthrax is a novel drug developed by Human Genome Sciences for

the prevention and treatment of anthrax infections. ABthrax is a human

monoclonal antibody that blocks the binding to cell surfaces of Bacillus

anthracis protective antigen, the key facilitator of anthrax infection.

ABthrax has received a Fast Track Product designation from the FDA for its

potential use in preventing and treating anthrax infections.(5)

As previously reported, a single dose of ABthrax administered prior to spore

challenge increases survival significantly in both rabbit and nonhuman

primate models of inhalational anthrax.(6)(7) Results from a more recent

study in a rabbit model of inhalational anthrax demonstrate that a single

dose of ABthrax also increases survival significantly when the dose is

administered following spore challenge, suggesting that the drug may have

the potential to protect against anthrax infection when administered either

prior to or after infection.

Human Genome Sciences has completed enrollment in a Phase 1 placebo-

controlled, dose-escalation clinical trial to evaluate the safety,

tolerability and pharmacokinetics of ABthrax in healthy adult volunteers.(8)

Data collection and analysis are in progress. The Company plans to submit an

abstract from the trial for presentation at the American Society of

Microbiology's Biodefense Meeting, which is scheduled for March 7-10 in

Washington, DC. Further development of ABthrax will depend on government

funding.

Oncology

TRAIL-R1 Agonistic Human Monoclonal Antibody (HGS-ETR1): HGS-ETR1 is a novel

anticancer drug that specifically recognizes and binds to the TRAIL (tumor

necrosis factor-related apoptosis-inducing ligand) Receptor-1 protein. The

TRAIL-R1 protein was originally identified by Human Genome Sciences, and is

found on the surface of a number of solid tumor and hematopoietic cancer

cells.

Human Genome Sciences is currently conducting Phase 1 clinical trials to

evaluate the safety and pharmacology of HGS-ETR1 in patients with advanced

solid tumors and hematological malignancies.(9) The Company has submitted an

abstract from a Phase 1 open-label, dose-escalating clinical trial of

HGS-ETR1 in patients with advanced solid tumors or non-Hodgkin's lymphomas

for presentation at the Annual Meeting of the American Society of Clinical

Oncology meeting, which is scheduled for June 5-8 in New Orleans.

Human Genome Sciences plans to advance HGS-ETR1 to Phase 2 clinical trials

in 2004.

TRAIL-R2 Agonistic Human Monoclonal Antibody (HGS-ETR2): HGS-ETR2 is a novel

anticancer drug that specifically recognizes and binds to the TRAIL

Receptor-2 protein. The TRAIL Receptor-2 protein was originally identified

by Human Genome Sciences, and is found on the surface of a number of solid

tumor and hematopoietic cancer cells.

Human Genome Sciences is currently enrolling patients with advanced tumors

into a Phase 1 open-label, dose-escalating clinical trial of HGS-ETR2. The

study will evaluate the drug's safety and pharmacology, and is being

conducted in the United Kingdom.(10) The Company recently received clearance

from the FDA of an IND application to initiate a Phase 1 open-label,

dose-escalating clinical trial of HGS-ETR2 in the United States.

The Company plans to complete enrollment of both Phase 1 trials of HGS- ETR2

in 2004.

LymphoRad 131: LymphoRad131 is a radioiodinated form of B-lymphocyte

stimulator (BLyS), a novel human protein discovered by Human Genome

Sciences.(11) The Company is developing LymphoRad for use in the treatment

of B-cell cancers such as multiple myeloma and non-Hodgkin's lymphoma.

Preliminary results from ongoing multi-center, open-label, dose-escalation

Phase 1 clinical trials of LymphoRad were presented in December 2003 at the

Annual Meeting of the American Society of Hematology (ASH).(12) The results

to date suggest that LymphoRad is safe and well tolerated, shows signs of

anti-tumor activity, and exhibits excellent dosimetry and tumor targeting.

Preliminary pharmacokinetic data from the first dose cohorts in the Phase 1

studies show that the administered radioactivity has a terminal half-life of

approximately eighteen to twenty-three hours, which is much shorter than is

reported for radiolabeled anti-CD20 antibodies. Enrollment in both trials is

expected to continue throughout most of 2004.

A. Haseltine, Ph.D., Chairman and Chief Executive Officer, Human

Genome Sciences, said, " Human Genome Sciences is a mid-stage development

biopharmaceutical company with a rich pipeline of novel human protein and

antibody drugs derived from proprietary genomic technology. In 2004, we will

focus on advancing clinical trials in two main therapeutic areas,

immunology/infectious disease and oncology. During 2004, we expect to

achieve significant clinical development milestones for a number of our

products. We also plan to advance one to two novel drugs to Phase 1 clinical

trials. "