- Preliminary Clinical Data for Albutropin(TM) And
Albuferon(TM)-alpha Phase 1 presented - Funding Assured, with $1.6 Billion in Cash and Equivalents -
ROCKVILLE, Md., April 30 /PRNewswire-FirstCall/ -- Human Genome Sciences,
Inc. (Nasdaq: HGSI) today told approximately 200 financial analysts in New
York that the company expects to file four Investigational New Drug (IND)
applications in 2002, seeking clearance from the U.S. Food and Drug
Administration (FDA) to begin clinical trials of its new drugs. In a press
release issued earlier today, Human Genome Sciences announced that it has
received FDA clearance to begin clinical development of a novel anticancer
drug, a human monoclonal antibody to TRAIL Receptor-1 (TRAIL-R1 mAb).(1) (A
webcast of today's Human Genome Sciences Annual Analyst and Investor Meeting
may be accessed at http://www.hgsi.com .)
William A. Haseltine, Ph.D., Chairman and Chief Executive Officer, said,
"TRAIL-R1 mAb is an exciting new drug with a novel mechanism of action. It
may eventually offer a promising therapeutic option for the treatment of
certain solid tumors and cancers of hematopoietic origin. It is one of two
IND applications we have filed so far in 2002. The other IND application,
which is currently pending review at FDA, is for another novel anticancer
compound, LymphoRad(TM)(131). We are seeking clearance to investigate
LymphoRad(131) for use in treating multiple myeloma and other B-cell
tumors.(2) We hope to file two additional IND applications this year for new
Human Genome Sciences drugs."
During the meeting, Human Genome Sciences executives highlighted the
following key points:
* Human Genome Sciences has a rich product pipeline of clinical and
advanced preclinical compounds, including seven drugs in clinical
trials -- (1) TRAIL-R1 mAb for the treatment of solid tumors and
cancers of hematopoietic origin; (2) LymphoStat-B(TM) for the treatment
of lupus and rheumatoid arthritis; (3) BLyS(TM) (B-lymphocyte
stimulator) for common variable immune disorder (CVID) and
immunoglobulin-A deficiency; (4) Repifermin for venous ulcers and
cancer therapy-induced mucositis; (5) Albuferon(TM) for the treatment
of hepatitis C and chronic myelogenous leukemia; (6) Albutropin(TM) for
the treatment of growth hormone deficiency; and (7) Albuleukin(TM) for
the treatment of solid tumors.
* Encouraging preliminary interim clinical data were presented from
ongoing Phase 1 clinical studies of Albutropin (albumin-human growth
hormone) and Albuferon-alpha (albumin-interferon alpha-2b).
* Human Genome Sciences' pipeline includes seven drugs in clinical
development, one drug that is currently pending FDA clearance to begin
clinical trials, and many drugs in preclinical development. Each of
these drugs is intended for use in meeting significant unmet medical
* Human Genome Sciences' current pipeline is comprised of roughly two
thirds novel human protein drugs and antibody drugs arising from
genomics-based research, and one third new improved long-acting
versions of existing protein drugs.
* The success of Human Genome Sciences' drug discovery efforts rests
firmly on the company's expertise in genomics, the systematic
collection and understanding of human genes and their functions, as
well as its exclusive focus on developing human protein and antibody
* Human Genome Sciences now has more than 1,000 highly skilled employees,
with a concentration on protein and antibody drug development and
* Human Genome Sciences has protein and antibody manufacturing
capabilities in bacteria, yeast and mammalian cells, and is
constructing a commercial-scale protein and antibody drug manufacturing
facility that will enable the company to produce several different
protein and antibody drugs simultaneously.
* With $1.6 billion in cash and equivalents, Human Genome Sciences has
the financial strength necessary to advance that objective.
Albutropin and Albuferon-alpha Clinical Trials - Preliminary Results
Preliminary interim results of the open-label Phase 1 dose-escalating
safety trials of Albutropin and Albuferon-alpha were discussed. As expected,
both Albutropin and Albuferon-Alpha demonstrated substantially longer half-
life in serum than did the parental compounds.
Surrogate marker data were also presented for both drugs. The
significance of the surrogate marker data must be tempered by the very
preliminary and interim nature of the results. These results were obtained at
intermediate dose levels in the dose-escalation safety trials. Nonetheless,
the results were encouraging.
The level of insulin-like growth factor-1 (IGF-1) in serum is a robust
surrogate marker for the biological activity of human growth hormone. Higher
single doses of Albutropin were found to be capable of inducing prolonged
elevations in the level of IGF-1 in some patients. Phase 1 studies of
Albutropin continue. Dose-escalation studies are in progress using single
doses. Repeat dosing is now planned since biological responses are being
Phase 1 studies of Albuferon-alpha are in progress with patients who have
failed interferon treatment for Hepatitis-C (HCV) and continue to test
positive for active serum hepatitis-C virus. Levels of the enzyme, 2', 5'-
oligoadenylate synthetase (OAS), provide a surrogate marker for interferon-
alpha activity. A single dose of Albuferon-alpha has been demonstrated to be
capable of inducing elevated OAS levels for up to 28 days. More remarkably,
the HCV viral load was reduced by half a log in some patients treated with a
single dose. Along with continued escalation of single-dose exposure, repeat
dosing has been initiated to further assess safety and the durability of
biological activity. Once again, it is important to stress the relatively
small number of patients studied and the preliminary nature of the data.
Craig A. Rosen, Ph.D., Executive Vice President, Research and Development,
and David C. Stump, M.D., Senior Vice President, Drug Development, reported on
the progress of a number of Human Genome Sciences' drugs in clinical and
Dr. Rosen said, "We have an exceptionally rich product pipeline of
clinical and advanced preclinical compounds. Seven of our drug candidates are
now in clinical development. These include two therapeutic proteins, two
human monoclonal antibodies, and three improved long-acting versions of
existing therapeutic proteins. We expect soon to receive FDA clearance to
begin human clinical study of a radiolabeled protein. I am not aware of
another biotechnology company with the depth and breadth of quality new drug
candidates that we have developed at Human Genome Sciences."
The Human Genome Sciences oncology franchise now includes nine compounds
-- six anti-tumor drugs and three cancer supportive care drugs.
ONCOLOGY -- ANTI-TUMOR DRUGS
LymphoRad(131) is a radiolabeled form of B-Lymphocyte Stimulator (BLyS), a
naturally occurring human protein discovered by Human Genome Sciences.
Preclinical studies show that LymphoRad(131) binds to receptors that are found
exclusively on B cells and B-cell tumors. Such tumors are sensitive to
killing by the attached radioisotope. LymphoRad(131) is currently awaiting
FDA clearance to begin human clinical development.
Dr. Stump said, "The recent clinical success of radiolabeled human
antibodies for B-cell tumors validates the concept of LymphoRad as an
antitumor drug. Initially, we plan to test LymphoRad(131) in patients
suffering from multiple myeloma. Multiple myeloma tumors display receptors
for LymphoRad but generally lack the CD-20 receptor, suggesting that
LymphoRad(131) may provide a novel treatment option for people with such
disease. LymphoRad(131) has the potential to treat a broad range of other B-
cell tumors as well, including large B-cell lymphomas, follicular B-cell
lymphomas, chromic lymphocytic leukemia, and Burkitt's lymphoma. The need for
new treatments for B-cell cancers is great. I look forward to the prospect of
initiating clinical study of LymphoRad(131) in the second half of 2002."
TRAIL-R1 and TRAIL-R2 Receptor Antibodies
The TRAIL-R1 and TRAIL-R2 "death receptors" are found on the surface of
many solid tumors. Human Genome Sciences announced today that it has received
FDA permission to begin clinical study of TRAIL-R1 mAb, a human monoclonal
antibody to TRAIL Receptor-1.(1) Both antibodies trigger the death of
receptor-bearing tumors. These antibodies may have an advantage over the
natural TRAIL ligand, as they do not recognize so-called "decoy receptors"
that are often displayed on the surface of tumors in addition to the active
Dr. Rosen said, "The emergence of death receptors as targets for
anticancer research has generated considerable excitement in the oncology
community. TRAIL-R1 mAb is an agonistic antibody that stimulates activity.
To my knowledge, TRAIL-R1 mAb is the first human agonistic antibody to enter
Dr. Stump said, "We believe that TRAIL-R1 mAb has significant potential
for use in treating a broad range of cancers and look forward to investigating
its use in clinical trials. Preclinical studies suggest that TRAIL-R1 mAb may
have therapeutic benefit in the treatment of human malignancies either as a
single agent or in combination with chemotherapy. Following completion of the
initial Phase 1 study to evaluate the drug's safety and pharmacology, we hope
to explore the use of TRAIL-R1 mAb in treating a number of tumor types."
TRAIL-R2 mAb, a human monoclonal antibody that recognizes TRAIL Receptor-
2, is in preclinical development.
Albuleukin and Albuferon-alpha
Albuleukin(TM) and Albuferon(TM)-alpha are new long-acting versions of the
existing protein drugs interleukin-2 and interferon-alpha. Both drugs are
active antitumor drugs. These new compounds were constructed by Human Genome
Sciences scientists by fusing the gene for the existing drug to human albumin.
The resulting fusion protein retains the activity of the parent compound, but
may have several advantages. Both Albuleukin and Albuferon-alpha have an
extended half-life in serum and may display reduced toxic effects as compared
to the original drugs. Both compounds have been approved for clinical trials
for the treatment of cancers.(3),(4) Enrollment for studies should proceed
throughout 2002. Albuferon-alpha is also the subject of an ongoing Phase 1
study for use in treating hepatitis-C (see below under AUTOIMMUNITY AND
VEGF-2 Monoclonal Antibody
Vascular Endothelial Growth Factor-2 (VEGF-2) is a human protein
discovered by Human Genome Sciences that stimulates formation of both blood
and lymph vessels. Studies in the scientific literature implicate VEGF-2 as
important for the metastatic spread of breast and melanoma tumors to lymph
nodes. The company has developed a human monoclonal antibody that neutralizes
the activity of VEGF-2 and is an active antitumor agent in preclinical
studies. Additional laboratory studies in progress are designed to test the
suitability of VEGF-2 monoclonal antibody as a clinical candidate.
ONCOLOGY -- CANCER SUPPORTIVE CARE
Three of the nine cancer drugs in Human Genome Sciences' cancer pipeline
have a primary indication for supportive care of patients undergoing
chemotherapy. These include Albupoietin, Albugranin and Repifermin.
Albupoietin and Albugranin
Albupoietin(TM) and Albugranin(TM) are new long-acting versions of
erythropoietin and granulocyte colony stimulating factor (G-CSF) respectively.
Both Albupoietin and Albugranin may help patients recover from damage to their
blood-forming tissues. Albupoietin should act to restore red cell levels to
combat anemia, whereas Albugranin should stimulate the replacement of missing
neutrophils to help prevent infections. Preclinical studies show that
Albupoietin compares favorably both in terms of activity and half-life with
both erythropoietin and the new modified version of erythropoietin called
Aranesp(TM). The preclinical profile of Albugranin also indicates that it is
comparable to Neulasta(TM) and has a longer half-life than G-CSF, while
retaining activity.(5) This combination of activity and half-life is such
that administration of one dose of the drug per round of chemotherapy may be
feasible. Human Genome Sciences recently announced plans to accelerate
development of Albugranin, and reported today on advanced preclinical studies
Repifermin is a human protein we discovered that promotes the healing of
wounds to the mucosal tissue. The primary indication for this drug is the
repair of wounds to the skin (see TISSUE REPAIR below). Human Genome
Sciences' initial clinical studies of Repifermin showed repifermin to be both
well tolerated and active in helping to heal wounds.(6) Repifermin may also
be used to protect cancer patients from damage to the mucosal tissue arising
from chemotherapy and radiation treatments.(7)
The company's initial Phase 2 study of Repifermin for protection of oral
mucositis showed the drug to be well tolerated. However, at the doses tested,
no activity was demonstrated in this trial, in which the drug was administered
after chemotherapy. Preclinical experiments now suggest that Repifermin may
be more active when given prior to mucosal injury. We are conducting a second
trial of Repifermin for the prevention of oral mucositis in which the drug is
administered both before and after chemotherapy.(8)
AUTOIMMUNITY AND IMMUNOLOGY
Many chronic diseases result from mis-regulation of the immune system,
including autoimmune diseases as well as immunodeficiencies. Additionally,
the immune system may be mobilized to fight chronic infections. Human Genome
Sciences is developing four drugs in this therapeutic area.
LymphoStat-B(TM) is the human monoclonal antibody that inactivates B-
Lymphocyte Stimulator (BLyS), a protein discovered by Human Genome Sciences
that stimulates the production of antibodies. The company's scientists, along
with others, have reported in the scientific literature that some patients
with systemic lupus erythematosus and severe arthritis have elevated levels of
BLyS in their circulation. Excessive amounts of the protein induce lupus in
laboratory studies. Overproduction of autoimmune-inducing antibodies may be
counteracted by reducing BLyS levels with LymphoStat-B. Human Genome
Sciences has initiated a Phase 1 clinical trial of LymphoStat-B in systemic
lupus erythematosus and will be enrolling patients into the study throughout
Dr. Stump said, "LymphoStat-B has generated considerable enthusiasm in the
lupus clinical community. Enrollment in our initial Phase 1 study is going
very well. This drug has the potential to treat a family of serious
autoimmune diseases. If the initial Phase 1 trials are successful, we hope to
be able to add new indications for additional trials for patients with
rheumatoid arthritis and other autoimmune diseases."
B-Lymphocyte Stimulator (BLyS)
B-Lymphocyte Stimulator is a human protein discovered by Human Genome
Sciences that stimulates the production of increased levels of antibodies.
The drug acts to increase the number and activity of antibody-producing plasma
cells. We currently are conducting Phase 1 clinical studies of BLyS(TM) in
patients with antibody deficiency diseases, including common variable
immunodeficiency disease (CVID)(10) and deficiencies in one specific type of
antibody, immunoglobulin-A.(11) We have been granted orphan drug status for
treatment of CVID patients with BLyS.(12) Enrollment for these studies should
proceed throughout 2002.
Albuferon-alpha and Albuferon-beta
Albuferon(TM)-alpha and Albuferon(TM)-beta are new long-acting forms of
interferon-alpha and interferon-beta, respectively. The drugs were created by
fusing the genes for the parent drug to that for human albumin. Preclinical
studies show that both drugs are active and have longer half-lives than do the
Human Genome Sciences has initiated human trials for Albuferon-alpha for
the treatment of patients with hepatitis C.(13) Interferon-alpha alone has
been shown to be an effective antiviral drug. We hope that Albuferon-alpha
will be more effective and perhaps better tolerated than interferon-alpha.
Albuferon-alpha is also the subject of clinical study for use in treating
chronic myelogenous leukemia (see ONCOLOGY -- ANTI-TUMOR DRUGS, above).
Dr. Stump said, "The preliminary clinical data presented today seem to
confirm our preclinical findings that Albuferon-alpha demonstrates
substantially longer half-life in serum than does interferon-alpha. While it
is important to stress the small number of patients and the preliminary nature
of the data, it is well known that levels of the OAS enzyme constitute an
important surrogate marker for interferon-alpha activity. To see indications
that a single dose of Albuferon-alpha may be capable of inducing elevated OAS
levels for up to 28 days is encouraging. To also see patients respond who
were previously shown to be resistant to interferon-alpha is even more
Interferon-beta has been demonstrated to be an effective treatment for
patients with multiple sclerosis. However, the dosing regimen as well as the
side effects of interferon-beta are less than optimal. Albuferon-beta may
address patient needs in both areas. The long-acting properties of Albuferon-
beta compared with the parent compound may allow less frequent dosing, while
the dose schedule and sustained activity of Albuferon-beta may also reduce
side effects. Human Genome Sciences is currently conducting additional
preclinical tests designed to support an IND application for Albuferon-beta.
DIABETES AND METABOLISM
Diabetes, obesity and other metabolic disorders pose serious and growing
threats to health. Human Genome Sciences recently initiated systematic
efforts to discover new human proteins and antibodies that could be used to
treat these diseases. The company now has five new drug candidates in this
GMAD-1 and GMAD-2
GMAD-1 is a novel human protein that emerged from Human Genome Sciences'
screening programs designed to find new proteins and antibodies to treat
diabetes and obesity. It affects multiple metabolic pathways involved in
diabetes and obesity. GMAD-2 is a monoclonal antibody active in the same
pathway as GMAD-1. Human Genome Sciences continues to explore the fundamental
biology of GMAD-1 and GMAD-2 and to conduct additional preclinical experiments
designed to enable the company to translate this exciting discovery into new
compounds that may be used to treat both diabetes and obesity.
There is a recognized need to establish and maintain a low basal level of
insulin activity in patients with Type 1 and Type 2 diabetes. Albulin is a
novel long-acting form of insulin. The drug was created by fusing the gene
for human insulin to that for human albumin. In preclinical studies, Albulin
is active in reducing blood glucose levels for a prolonged period. Additional
preclinical studies are in progress to support an IND application for this
drug candidate for the treatment of Type 1 and Type 2 diabetes. Preclinical
studies suggest that Albulin may perform better than Glargine(TM), the current
best candidate for a slow-acting drug.
Albugon is a long-acting form of a human peptide that has been
demonstrated to lower blood glucose levels in patient and animal studies.
Albugon was created by fusing a gene developed to produce an active form of
the peptide to the gene for human albumin. Preclinical studies are in
progress to support an IND application. These studies demonstrate that Human
Genome Sciences' albumin fusion technology can be used to create long-acting
Albutropin is a long-acting form of human growth hormone. The drug was
created by fusion of the gene for human growth hormone to that for human
albumin. Albutropin has a longer half-life in serum than does growth hormone
itself. Preclinical studies demonstrate that Albutropin stimulates increased
serum levels of insulin-like growth factor (IGF-1), a natural messenger for
the metabolic effects of growth hormone.
The primary indication of Albutropin is metabolic, for the treatment of
growth hormone deficiency. A Phase 1 clinical trial is underway in growth
hormone-deficient adults.(14) Preliminary data from this trial was presented
at today's meeting. Human Genome Sciences also intends to evaluate Albutropin
for the treatment of growth hormone-deficient children as soon as its safety
has been demonstrated in adults.
Dr. Stump said, "Levels of insulin-like growth factor-1 (IGF-1) are known
to be a robust surrogate marker for the biological activity of human growth
hormone. Preliminary data from a small number of patients in the current
Phase 1 study indicate that higher single doses of Albutropin can produce
prolonged elevations in the level of IGF-1. These results were obtained at
intermediate dose levels in the dose-escalation process and are clearly
supportive of our objectives for Albutropin, although it is important to
maintain the perspective that these data are preliminary and interim, and that
we must await the final study results before coming to firm conclusions."
Human Genome Sciences is developing two drugs in the area of tissue
repair, one to repair wounds to the skin and gastrointestinal tract, and a
second to treat injuries to the lung. The company believes that many more
naturally occurring human proteins will eventually be discovered that may be
used to repair a wide variety of tissue injuries.
Repifermin is a human protein discovered by Human Genome Sciences that
stimulates the repair of injured skin and mucosal tissues (also see ONCOLOGY
-- CANCER SUPPORTIVE CARE, above). Human Genome Sciences is conducting
clinical trials of Repifermin in patients with chronic skin ulcers.
Preliminary trials demonstrated that Repifermin is active and well tolerated
for the formation of new skin in patients with venous ulcers, when compared to
a placebo control group. A large Phase 2B clinical trial of Repifermin for
the treatment of venous ulcers is underway, which is designed to demonstrate
its ability to completely heal these wounds.
LF-B25 is a human protein Human Genome Sciences discovered that is active
in stimulating the growth of at least two important cell types in the lung.
LF-B25 stimulates the growth of type 2 alveolar cells, leading to the
possibility that it may be used to treat patients with both chronic and acute
lung injury. The drug candidate also stimulates the growth of bronchial
endothelial cells and may therefore be used for the treatment of patients with
emphysema. Human Genome Sciences is currently exploring the range of
applications for this exciting new drug candidate and is working to develop
convenient and effective formulations for deep lung delivery.
Osteoporosis is a serious and growing medical problem in the aging
population. Human Genome Sciences has discovered two human proteins that may
be useful for the treatment of this disease. The company also has designed
two long-acting forms of proteins known to affect bone metabolism.
The drug candidate Albutegrin, is a long-acting form of a human protein
that Human Genome Sciences discovered. The parent protein inhibits formation
of osteoclasts, cells that destroy bone. Studies suggest that the protein
plays an active role in inhibiting bone loss. Albutegrin was created by
fusion of the gene that encodes the osteoclast inhibitory protein to that for
human albumin. Human Genome Sciences judged it preferable to begin studies of
Albutegrin with a long-acting, rather than a short-acting, form of the
protein. Preclinical studies in progress are designed to support the
feasibility of developing this clinical candidate.
Osteostat is a second human protein discovered by Human Genome Sciences
that inhibits formation of osteoclasts and acts by a novel mechanism distinct
from that of Albutegrin. Preclinical experiments show that Osteostat plays an
important role in bone metabolism. The company is currently conducting
additional preclinical experiments to evaluate how this new protein might be
used to treat and prevent osteoporosis.
Albutonin and Albuthyrin
Albutonin and Albuthyrin are novel long-acting forms of the human peptides
calcitonin and parathyroid hormone, both of which stimulate bone formation.
These drugs were created by fusing a gene designed to produce the protein to
the gene for human albumin. The resultant proteins possess the activity of
the proteins themselves, yet have a longer serum half-life. Human Genome
Sciences is conducting additional preclinical studies with both drug
candidates to support separate IND applications.
HIV/AIDS is a serious threat to health worldwide. The number of infected
patients is rising rapidly; and strains of HIV resistant to many drugs account
for up to half the infections in developed countries. New antiviral drugs to
treat the disease and drugs to support AIDS patients are urgently needed.
CCR5 is a human chemokine receptor that is required for HIV infection.
Human Genome Sciences was the first to discover this receptor and recognize
its natural function. Drugs that block binding of HIV to CCR5 block infection
and therefore may be useful for treatment of the disease. Human Genome
Sciences has developed a human monoclonal antibody to CCR5 that inhibits HIV
infection. The company is conducting preclinical studies designed to support
an IND application for this candidate. The development of anti-CCR5 drugs is
a competitive area associated with complex patent applications. Human Genome
Sciences has been issued a patent that describes the CCR5 gene and some of its
HGS-HIV/AIDS 27 (HGS-H/A 27) is a long-acting version of a human protein
discovered by Human Genome Sciences that inhibits HIV replication. The
natural form of the protein has a potent inhibitory effect on virus
replication in cell culture. The company created HGS-H/A 27 by fusion of the
gene that encodes the HIV inhibitory protein to that for human albumin. Human
Genome Sciences believes that a long-acting form of the protein may have
improved antiviral properties compared to the parent compound, and is
currently conducting preclinical experiments with this drug.
Human Growth Hormone (hGh) is approved for the treatment of AIDS wasting
syndrome. A long-acting form of hGh should be attractive for this use as
For additional information on Human Genome Sciences, please visit our web
site at http://www.hgsi.com . Health professionals interested in clinical
studies involving HGSI products are encouraged to inquire via the Contact Us
section of the Human Genome Sciences web site,
http://www.hgsi.com/products/request.html , or by calling us at 301-610-5790,
Human Genome Sciences is a company with the mission to treat and cure
disease by bringing new gene-based drugs to patients.
HGS, Human Genome Sciences, Albuferon, Albugranin, Albuleukin,
Albupoietin, Albutropin, BLyS, LymphoRad and LymphoStat-B are trademarks of
Human Genome Sciences, Inc. All other trademarks and tradenames are the
property of their respective owners.
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, dependence on new
technologies, uncertainty and timing of clinical trials, ability to develop
and commercialize products, dependence on collaborators for services and
revenue, substantial indebtedness, intense competition, uncertainty of patent
and intellectual property protection, dependence on key management,
uncertainty of regulation of products, dependence on key suppliers, the impact
of future alliances or transactions and other risks that may be 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.
1. April 30, 2002: Human Genome Sciences Initiates Trial of Novel
2. January 23, 2002: Human Genome Sciences Files Investigational New Drug
Application For Lymphorad131
3. January 7, 2002: Human Genome Sciences Initiates Trial of
Albuleukin(TM), a Recombinant Human Protein for Treating Solid Tumor
4. See Albuferon-alfa product backgrounder at
5. April 15, 2002: Human Genome Sciences Announces Development Plans for
Drugs to Treat Chemotherapy-Induced Neutropenia
6. February 10, 1999: Human Genome Sciences Initiates Phase 2 Human
Clinical Trials of KGF-2, a New Wound-Healing Drug
7. January 19, 2000: Human Genome Sciences Announces Phase 2 Human
Clinical Trials of Repifermin for Cancer Treatment Related Mucositis
8. December 7, 2001: Results of Two Phase 2a Clinical Trials Show
Excellent Safety Profile for Repifermin
9. November 1, 2002: Human Genome Sciences Initiates Trial of a New Drug
for Systemic Lupus Erythematosus and Other Autoimmune Diseases
10. June 23, 2000: Human Genome Sciences to Initiate Human Clinical Trials
11. September 19, 2001: Human Genome Sciences Announces Trial for
Treatment of Immunoglobulin-A Deficiency
12. February 27, 2001: Human Genome Sciences Receives Orphan Drug
Designation for BLyS, Therapeutic Protein for Treatment of Common
13. March 23, 2001: Human Genome Sciences Begins Phase 1 Clinical Trial
of Albuferon in Hepatitis C Patients
14. June 5, 2001: Human Genome Sciences' Albutropin(TM) IND Cleared