HUMAN GENOME SCIENCES BEGINS DOSING OF PATIENTS IN A PHASE 2 CLINICAL
TRIAL OF HGS-ETR1 IN NON-HODGKIN’S LYMPHOMA
– Clinical trial of novel genomics-derived anticancer drug is the third
Phase 2 study of the drug to be initiated in 2004 –
ROCKVILLE, Maryland – October 13, 2004 – Human Genome Sciences, Inc.
(Nasdaq: HGSI) announced today that it has begun dosing patients in a
Phase 2 clinical trial of HGS-ETR1 (agonistic human monoclonal antibody
to TRAIL Receptor 1) in patients with advanced non-Hodgkin’s lymphoma.
The Phase 2 clinical trial is a multi-center, open-label study to
evaluate the efficacy, safety and tolerability of HGS-ETR1 in patients
with relapsed or refractory non-Hodgkin’s lymphoma. The Phase 2 study
will enroll a maximum of thirty patients. Each patient will receive up
to six cycles of treatment in the absence of disease progression, with
HGS-ETR1 administered as an intravenous infusion once every twenty-one
days. The objectives of the study are to evaluate disease activity and
tumor response to HGS-ETR1 in patients with advanced non-Hodgkin’s
lymphoma, to evaluate the safety and tolerability of HGS-ETR1, and to
determine plasma concentrations of HGS-ETR1 for use in a population
pharmacokinetic analysis. Disease response will be assessed using the
International Working Group Recommendations for Non-Hodgkin’s Lymphoma,
which were established in 1999 to provide an objective means for
evaluating changing disease status and the efficacy of drugs in the
treatment of non-Hodgkin’s lymphoma.1
In a separate press release distributed earlier today, Human Genome
Sciences announced that it has begin dosing patients in a Phase 2
clinical trial of HGS-ETR1 in patients with advanced colorectal cancer.2
On September 8, 2004, the company announced the initiation of a Phase 2
study of HGS-ETR1 in patients with advanced non-small cell lung cancer.3
The three Phase 2 studies of HGS-ETR1 initiated to date fit into a
global clinical development program through which Human Genome Sciences
plans to evaluate the novel, genomics-derived anticancer drug’s
potential for use in the treatment of specific cancers.
Anas Younes, M.D., Professor, Lymphoma/Myeloma, University of Texas M.D.
Anderson Cancer Center, Houston, said, “Non-Hodgkin’s lymphoma is the
seventh most common cancer in the United States, with approximately
56,000 new cases diagnosed each year. 4 The current standard of care
calls for treating most patients with a combination of chemotherapy and,
in recent years, monoclonal antibodies. This therapeutic approach
produces cures in approximately fifty percent of patients with
aggressive lymphoma. Those who relapse or do not respond are treated
with additional chemotherapeutic and other therapeutic modalities, but
cures are difficult to achieve. New therapies that can improve response
rates, extend the duration of response, extend survival, minimize
toxicity, and provide patients with improved quality of life represent a
significant need. We look forward to evaluating HGS-ETR1 to determine
whether it may play a role in the treatment of non-Hodgkin’s lymphoma.” 5-13
David C. Stump, M.D., Executive Vice President, Drug Development, said,
“The interim results from our ongoing Phase 1 clinical trials of
HGS-ETR1 demonstrate that it is well tolerated and can be safely and
repetitively administered to patients with non-Hodgkin’s lymphoma or
advanced solid tumors.14-19 Based on the clinical evidence to date,
along with strong preclinical support, we are pleased to initiate a
Phase 2 study of HGS-ETR1 in patients with non-Hodgkin’s lymphoma. We
look forward to continuing to elucidate the potential of HGS-ETR1 as a
treatment for solid tumor and other malignancies.”
Craig A. Rosen, Ph.D., President and Chief Operating Officer, said, “The
advancement of HGS-ETR1 to Phase 2 clinical trials is one of the key
milestones that we set for Human Genome Sciences at the beginning of
2004. We are now moving forward with a broad Phase 2 program of clinical
study to investigate the use of HGS-ETR1 in the treatment of specific
cancers, including colorectal cancer, non-small cell lung cancer, and
non-Hodgkin’s lymphoma. The results of our own in vitro and in vivo
preclinical studies, as well as studies conducted by others, demonstrate
that agonistic antibodies to TRAIL Receptors 1 and 2 have significant
potential to provide novel therapeutic options to patients with a
variety of cancer types, including non-Hodgkin’s lymphoma. 20-45 Our
preclinical studies also show that the activity of HGS-ETR1 may be
increased by co-treatment with chemotherapeutic agents.”46-52
Interim results of two ongoing Phase 1 multi-center, open-label,
dose-escalation clinical trials of HGS-ETR1 were presented in September
2004 at the 16th EORTC-NCI-AACR Symposium on Molecular Targets and
Cancer Therapeutics in Geneva, Switzerland. 14-16 The data presented
demonstrate the safety and tolerability of HGS-ETR1 in patients with
advanced solid tumors or non-Hodgkin’s lymphoma, and support further
evaluation of HGS-ETR1 in Phase 2 clinical trials, both as a single
agent and in combination with chemotherapy. Data were presented on
thirty-nine patients treated to date in a Phase 1 study conducted in
patients with advanced solid tumors.14, 16 Interim results of the
ongoing study demonstrate that HGS-ETR1 can be administered safely and
repetitively to patients with advanced solid malignancies at doses up to
and including 10 mg/kg intravenously every 28 days. No evidence of
drug-related hematologic or hepatic toxicity has been observed at the
doses administered to date. The Maximum Tolerated Dose (MTD) has not
been reached, and accrual in the trial continues at a dose of 10 mg/kg
every 14 days. Some preliminary evidence of biological activity has been
observed. Durable stable disease for greater than eight months was
observed in one patient with metastatic sarcoma. Durable stable disease
was observed for four months in one patient with head-and-neck cancer
and in one patient with Ewing’s sarcoma; both patients continue on
treatment. Data also were presented on twenty-four patients treated to
date in an additional Phase 1 study conducted in patients with advanced
solid tumors or non-Hodgkin’s lymphoma. Results presented from the
ongoing clinical trial demonstrate that HGS-ETR1 is well tolerated with
no clearly attributable toxicities to date and that the MTD has not been
reached. Stable disease has been observed in eight patients for greater
than two cycles. The trial continues to enroll patients.15-16
Human Genome Sciences, using genomic techniques, originally identified
the TRAIL Receptor-1 protein as a member of the tumor necrosis factor
receptor super-family. The company’s own studies, as well as those
conducted by others, show that TRAIL Receptor 1 plays a key role in
triggering apoptosis, or programmed cell death, in tumors. Human Genome
Sciences took the approach of developing human monoclonal antibodies
that would bind the receptor and stimulate the TRAIL Receptor-1 protein
to trigger apoptosis in cancer cells, in much the same way that the
native TRAIL ligand (tumor necrosis factor-related apoptosis-inducing
ligand) triggers it, but with the advantage of a longer half-life and an
exclusive specificity for TRAIL Receptor 1. The TRAIL Receptor 1
agonistic human monoclonal antibody, HGS-ETR1, was made in a
collaboration between Human Genome Sciences and Cambridge Antibody
Technology.53 The drug will be produced in the Human Genome Sciences
clinical manufacturing facilities located in Rockville, Maryland. Human
Genome Sciences holds the commercial rights to the drug.
For more information about HGS-ETR1, see
www.hgsi.com/products/ETR1.html. Health professionals interested in more
information about trials involving HGSI products are encouraged to
inquire via the Contact Us section of the Human Genome Sciences web
site, www.hgsi.com/products/request.html, or by calling (301) 610-5790,
extension 3550.
Human Genome Sciences is a company with the mission to treat and cure
disease by bringing new gene-based protein and antibody drugs to patients.
HGS and Human Genome Sciences are trademarks of Human Genome Sciences, Inc.
This announcement contains forward-looking statements within the meaning
of Section 27A of the Securities Act of 1933, as amended, and Section
21E of the Securities Exchange Act of 1934, as amended. The
forward-looking statements are based on Human Genome Sciences’ current
intent, belief and expectations. These statements are not guarantees of
future performance and are subject to certain risks and uncertainties
that are difficult to predict. Actual results may differ materially from
these forward-looking statements because of the Company’s unproven
business model, its dependence on new technologies, the uncertainty and
timing of clinical trials, the Company’s ability to develop and
commercialize products, its dependence on collaborators for services and
revenue, its substantial indebtedness and lease obligations, its
changing requirements and costs associated with planned facilities,
intense competition, the uncertainty of patent and intellectual property
protection, the Company’s dependence on key management and key
suppliers, the uncertainty of regulation of products, the impact of
future alliances or transactions and other risks described in the
Company’s filings with the Securities and Exchange Commission. Existing
and prospective investors are cautioned not to place undue reliance on
these forward-looking statements, which speak only as of today’s date.
Human Genome Sciences undertakes no obligation to update or revise the
information contained in this announcement whether as a result of new
information, future events or circumstances or otherwise.
###
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FOR IMMEDIATE RELEASE
CONTACTS:
David C. Stump, M.D.
Executive Vice President, Drug Development
240/314-4400
Jerry Parrott
Vice President, Corporate Communications
301/315-2777
Kate de Santis
Director, Investor Relations
301/251-6003