MORRIS PLAINS, N.J., June 1 /PRNewswire-FirstCall/ -- Immunomedics, Inc.
(Nasdaq: IMMU), a leading biopharmaceutical company focused on developing
monoclonal antibodies, today announced patient dosing has begun for the
pivotal Phase III clinical trials to further evaluate the safety and efficacy
of the Company's lead drug candidate, epratuzumab, for the treatment of
patients with systemic lupus erythematosus (SLE), known as lupus.
Epratuzumab has been designated by the U.S. Food and Drug Administration
(FDA) as a Fast Track product for the potential treatment of patients with
moderate and severe SLE. Epratuzumab is a humanized monoclonal antibody that
targets an antigen, known as CD22, found on the surface of a certain class of
lymphocytes, a type of white blood cell.
"Epratuzumab has shown activity in patients with SLE with mild depletion
of circulating B-lymphocytes. This suggests epratuzumab may work by
modulating B-cell function, as contrasted with other B-cell antibodies that
appear to require depletion of B-cells. It also implies a possible reduction
in the risk of infection, which is commonly associated with lupus, and can be
life-threatening. We are pleased to advance our lead drug candidate,
epratuzumab, into pivotal Phase III lupus trials, and to be at the forefront
of lupus therapy research," commented Ivan D. Horak, M.D., Executive Vice
President, Research and Development, and Chief Scientific Officer of
Immunomedics.
"There is a need for a new drug that addresses and improves the quality of
life for the estimated 3 to 5 million patients worldwide afflicted with lupus,
a debilitating and often life-threatening disease. We are pleased that
Pharmaceutical Product Development, Inc. (Nasdaq: PPDI) will work with us to
execute these pivotal trials," said Cynthia L. Sullivan, President and Chief
Executive Officer of the Company. "We continue to hold discussions with
potential partners for epratuzumab in all indications, with the aim of
securing the best possible agreement for further development of our product
and to maximize value for our shareholders."
The pivotal trials are randomized, double-blinded, placebo-controlled,
multi-center studies using the BILAG (British Isles Lupus Assessment Group)
index to monitor and assess disease activity. A high BILAG score indicates
increased disease activity. The trials have been named "ALLEVIATE" or
Alleviate Lupus Affliction with Epratuzumab and Validate its Autoimmune Safety
and Efficacy. One trial, ALLEVIATE A, is for patients with severe SLE flares,
and the second trial, ALLEVIATE B, is for patients with moderately active SLE.
About Epratuzumab
Epratuzumab is Immunomedics' lead product candidate being evaluated in two
pivotal Phase III trials for the treatment of moderate and severe SLE. The
FDA granted a Fast Track designation to the clinical development program for
epratuzumab for the treatment of patients with SLE. Epratuzumab has also
demonstrated good safety, tolerability, and clinical efficacy in more than 340
patients with non-Hodgkin's lymphoma, resulting in reports published in The
Journal of Clinical Oncology and Clinical Cancer Research.
About Systemic Lupus Erythematosus
Systemic lupus erythematosus (SLE) is a serious autoimmune disease
affecting approximately 1.5 million Americans, according to the Lupus
Foundation of America. In the U.S., women with SLE outnumber men by a ratio
of nine to one, and 80% of female patients develop lupus between the ages of
15 and 45. At present, there is no cure for lupus and no new lupus drug has
been approved in the U.S. for nearly 40 years. Lupus most often results in
chronic inflammation and pain affecting various parts of the body, especially
the skin, joints, blood, and kidneys. The disease can be serious and life
threatening. Current treatments used in medical practice include
corticosteroids, nonsteroidal anti-inflammatory drugs, immunosuppressives, and
antimalarials. The FDA has recently issued a draft guideline to industry on
developing drugs for the treatment of SLE that is available at
http://www.fda.gov/cder/guidance/6496dft.pdf .
About Immunomedics
Immunomedics is a New Jersey-based biopharmaceutical company focused on
the development of monoclonal antibody-based products for the targeted
treatment of cancer, autoimmune and other serious diseases. We have developed
a number of advanced proprietary technologies that allow us to create
humanized antibodies that can be used either alone in unlabeled or "naked"
form, or conjugated with radioactive isotopes, chemotherapeutics or toxins, in
each case to create highly targeted agents. Using these technologies, we have
built a pipeline of therapeutic product candidates that utilize several
different mechanisms of action. Our lead product candidate, epratuzumab, is
currently beginning two pivotal Phase III trials, for the treatment of
patients with moderate and severe lupus. We believe that our portfolio of
intellectual property, which includes approximately 90 issued patents in the
United States, and more than 250 other issued patents worldwide, protects its
product candidates and technologies. Visit the Company's web site at
http://www.immunomedics.com .
This release, in addition to historical information, contains forward-
looking statements made pursuant to the Private Securities Litigation Reform
Act of 1995. Such statements, including statements regarding clinical trials,
out-licensing arrangements, and capital raising activities, involve
significant risks and uncertainties and actual results could differ materially
from those expressed or implied herein. Factors that could cause such
differences include, but are not limited to, risks associated with new product
development (including clinical trials outcome and regulatory
requirements/actions), competitive risks to marketed products and availability
of financing and other sources of capital, as well as the risks discussed in
the Company's Annual Report on Form 10-K for the fiscal year ended June 30,
2004. The Company is not under any obligation, and the Company expressly
disclaims any obligation, to update or alter any forward-looking statements,
whether as a result of new information, future events or otherwise
For More Information:
Dr. Chau Cheng
Associate Director, Investor Relations & Business Analysis
(973) 605-8200, extension 123
ccheng@immunomedics.com
Julie Huang
Financial Dynamics
(212) 850-5628
jhuang@fd-us.com
SOURCE Immunomedics, Inc.
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Related links:
http://www.Immunomedics.com
Company News On-Call:
http://www.prnewswire.com/comp/113121.html
CONTACT:
Dr. Chau Cheng, Associate Director, Investor
Relations & Business Analysis, +1-973-605-8200, ext. 123,
ccheng@immunomedics.com; Julie Huang of Financial Dynamics,
+1-212-850-5628, jhuang@fd-us.com, for Immunomedics, Inc.
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