FOR IMMEDIATE RELEASE
CONTACT:
Jerry Parrott
Vice President, Corporate Communications
301/315-2777
Kate de Santis
Director, Investor Relations
301/251-6003
HUMAN GENOME SCIENCES COMPLETES PATIENT ENROLLMENT
IN A PHASE 2 CLINICAL TRIAL OF HGS-ETR1 FOR THE TREATMENT OF
COLORECTAL CANCER
– One in a series of Phase 2 trials of the agonistic
human monoclonal
antibody to TRAIL receptor 1 –
ROCKVILLE, Maryland – February 23, 2005 – Human Genome Sciences,
Inc. (Nasdaq: HGSI) announced today that it has completed the
enrollment and initial dosing of patients in a Phase 2 clinical trial
of HGS-ETR1 (mapatumumab) in patients with advanced colorectal cancer.
The Phase 2 clinical trial is an open-label study to evaluate the
efficacy, safety and tolerability of HGS-ETR1 in patients with relapsed
or refractory colorectal cancer. 1 The Phase 2 study is
being conducted in Germany. Patients enrolled in the trial are
receiving up to six cycles of treatment in the absence of disease
progression, with HGS-ETR1 administered as an intravenous infusion once
every fourteen days. The primary objective of the study is to evaluate
tumor response. The secondary objectives are to evaluate the safety and
tolerability of HGS-ETR1, to determine plasma concentrations of
HGS-ETR1 for use in a population pharmacokinetic analysis, and to
evaluate other indicators of disease activity, including time to
response, duration of response, and progression-free survival.
Professor Dr. Siegfried Seeber, principal investigator and
Director, University Clinic for Internal Medicine and Policlinic (Tumor
Research), West German Tumor Center, University of Essen, Germany,
said, “Combinations of chemotherapeutic agents and, more recently,
monoclonal antibodies, have demonstrated clinical benefit for patients
with advanced colorectal cancer, but the prognosis for these patients
continues to be poor. 2-16 Less than ten percent of the
patients who develop metastatic disease survive for five years. 17-20
There is a significant medical need for effective new therapeutic
agents. We look forward to continuing the evaluation of HGS-ETR1
throughout the treatment phase of the current study.”
Florian Bieber, M.D., Vice President, Drug Development – Europe,
said, “The rapid enrollment of the Phase 2 trial of HGS-ETR1 reflects
the strong interest within the European oncology community in the
ability of our TRAIL receptor antibodies to inhibit or reduce tumor
growth in xenograft models of colorectal cancer, to induce significant
tumor regression in some models of the disease, and to trigger
apoptosis in numerous cancer cell lines, including colorectal cancer.”
David C. Stump, M.D., Executive Vice President, Drug Development,
said, “We
are pleased to have completed the enrollment of our Phase 2 clinical
trial of
HGS-ETR1 in patients with colorectal cancer. We also have completed the
enrollment
of our Phase 2 trial of HGS-ETR1 in non-small cell lung cancer, and we
continue
to enroll patients in our Phase 2 trial in non-Hodgkin’s lymphoma. 21-23
We expect to have the results of the three ongoing Phase 2 studies of
HGS-ETR1
available in 2005. Phase 1b studies of HGS-ETR1 in combination
with chemotherapy also are ongoing. The results of these trials
will inform our decisions regarding further single agent and
chemotherapy combination
development of HGS-ETR1 as a treatment for cancer. ”
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. 24-26
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 39 patients treated to date in a Phase 1 study conducted
in patients with advanced solid tumors. 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. 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 24 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 Maximum Tolerated Dose has not been reached.
Stable disease has been observed in eight patients for greater than two
cycles. The trial continues to enroll patients.
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.
Human Genome Sciences’ own clinical and preclinical studies, along with
published results in the scientific literature, demonstrate that
agonistic antibodies to the death domain-containing TRAIL receptors
have significant potential to provide novel therapeutic options to
patients with a variety of cancer types. 27-43
The TRAIL receptor 1 agonistic human monoclonal antibody, HGS-ETR1,
was made in a collaboration between Human Genome Sciences and Cambridge
Antibody Technology. 44 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.
Colorectal cancer is the second-leading cause of cancer-related
deaths in Western Europe and the United States (after lung cancer). The
overall five-year survival of patients with colorectal cancer is
approximately fifty percent.
For more information about HGS-ETR1, see www.hgsi.com/products/ETR1.html.
Health professionals interested in more information about trials
involving Human Genome Sciences products are encouraged to inquire via
the Contact Us section of the company’s 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.
Footnotes:
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