IMMU News
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MORRIS PLAINS, N.J., Feb. 9 /PRNewswire/ -- Immunomedics, Inc. (Nasdaq: IMMU - news) has been awarded a U.S.
patent covering disease-seeking antibody technology which the Company believes may revolutionize the way doctors detect
and treat cancer, infection, clots, and coronary heart disease in the 21st century.
Patent No. 5,716,595 covers use of small antibody molecules, or fragments, that detect and treat disease by targeting it with
''payloads'' of isotopes, drugs, fluorescent dyes and other substances. The antibody fragments attach these payloads to unique
proteins on the surface of tumors, drug-resistant bacteria, blood clots -- even blood cells that collect on fat-clogged arteries
before a heart attack.
The patent further grants exclusive rights to use hand-held radiation-detecting probes, laparoscopes, and endoscopes to locate
disease sites where those antibody fragments and their payloads attach. The patent also covers disease treatment by activating
payloads of tumor- and microbe-killing and clot-busting drugs, using radiation and special light sources, such as lasers.
''In its simplest form, a patient is injected with a minimally radioactive, disease-seeking antibody fragment that binds to a
specific protein on the surface of diseased cells, bacteria or blood clots,'' explained David M. Goldenberg, ScD, MD,
Chairman and CEO of Immunomedics. ''Then, within 24 to 48 hours the surgeon scans the patient's organs with a
radiation-detecting probe, to detect the sites of the cancer or other diseased tissue that need to be removed.''
According to Dr. Goldenberg, competitive diagnostic and therapeutic technologies use whole antibodies that are trapped by
the liver, and other tissues, and held there for 20 days, or longer. Those trapped antibodies force surgeons to delay treatment
for at least three weeks, versus the 24-48 hours enabled by the newly patented Immunomedics technology.
Patented Technology Helps Surgeons Find Hidden Cancer
Like Beachcombers Find Lost Coins
''Some surgeons in the U.S. and Europe are already capitalizing on this newly patented technology in an attempt to improve
the cure rate of colorectal cancer operations,'' Dr. Goldenberg reported. ''They're scanning the abdomens of their patients with
gamma probes, looking for tumors that concentrate antibody-linked isotopes, much as beachcombers scan the shoreline with
metal detectors, looking for coins buried in the sand.
''Ordinarily, about a third or more of the 138,000 Americans who undergo surgery for cancer of the colon or rectum
experience a recurrence within two years -- largely due to tumor tissue invisible at the time of the original operation,'' Dr.
Goldenberg said. ''Now, before the operation, physicians can 'light up' the larger tumors on a nuclear medicine camera by
injecting patients with our new cancer imaging agent, CEA-Scan(R) (arcitumomab), according to its current use approved in
the U.S., Canada and Europe.''
CEA-Scan contains a small antibody fragment that attaches a mild isotope to colorectal cancers that sometimes cannot be seen
by CT or other conventional tests. Surgeons can look at the nuclear camera scans and learn where they should focus their
search for disease during the operation.
''If the surgeons operate within 48 hours of this imaging study, the residual radioactivity from the preoperative scan can be
used during the operation to help them find otherwise invisible tumors,'' Dr. Goldenberg explained.
''Surgeons locate those hidden tumors using hand-held probes that detect the radiation attached to CEA-Scan antibody
fragments still clinging to those tumors up to two days after injected to make images,'' Dr. Goldenberg remarked. By placing
the probe directly atop a patient's organs, surgeons may pick up lesions as small as 2-3 mm -- far smaller than detectable with
most external imaging systems.
''Hopefully,'' Dr. Goldenberg said, ''removal or destruction of this additional tumor will give chemotherapy a chance to at least
extend the time between operation and recurrence and, perhaps, one day, truly cure metastatic cancers that kill three-quarters
or more of all patients who develop spread of their malignant disease. And since this detection uses residual radiation from the
preoperative imaging dose, that additional disease-detection and treatment capability comes at virtually no additional cost.''
Immunomedics has submitted to the U.S. Food and Drug Administration (FDA) an investigational protocol for this new use of
CEA-Scan. The planned study is intended to quantify the size, depth, and conditions necessary for surgeons to optimize their
use of detection probes with CEA-Scan in the treatment of colorectal cancer.
Immunomedics' Fragment Technology Overcomes Usual Problems with Antibodies
Immunomedics' recent patent adds to its already extensive portfolio of proprietary antibody technologies that form the basis of
the Company's disease targeting and diagnostic products.
For decades, the biotechnology and pharmaceutical industries have struggled with the challenge of targeting and treating
disease with antibodies. Whole antibodies, when injected into the bloodstream, are intercepted and held for days to weeks in
the liver, and other tissues, thus trapping any drug or isotope carried by the whole antibody.
Immunomedics made practical antibody fragments consisting mostly of the part of the antibody that binds to antigenic proteins.
By eliminating two-thirds of the other unnecessary portions, Immunomedics' scientists developed a rapidly targeting agent that
avoids the liver and many other tissues and is not generally allergic to the patient, even when made from animal cells.
''Antibody fragments are so small that they appear to 'stay below the body's immunologic radar screen,' thus avoiding the
immune response problems usually seen with whole antibody products,'' Dr. Goldenberg stated. ''This is the technological
basis for the quick, precise targeting that underpins our new patent and products.''
Company Seeking Drug, Device Partners
To Develop Coronary Disease Applications
Immunomedics acknowledges that it will have to form partnerships with the major pharmaceutical and catheter companies to
develop the broad cardiac diagnostic and therapeutic applications for this newly patented technology.
''Now that our technology is protected, we are arranging to present it to key companies that serve the billion-dollar,
worldwide, angioplasty catheter, stent, and heart imaging business,'' explained Mel Snyder, Immunomedics' Vice President of
Marketing.
''Current tests like angiograms, and even the familiar 'thallium stress test,' show little until coronary disease is quite advanced,''
Mr. Snyder commented. ''We believe our technology might detect earlier signs of the disease, when blood cells are first
beginning to deposit on lipid-coated walls of heart arteries,'' he added.
Immunomedics believes that its technology might not only detect such early disease, but could conceivably enable doctors to
determine whether diet and exercise are reversing atherosclerosis. It also might display whether a prescribed lipid-lowering
agent is reducing heart attack risk, or if a stent inserted to keep an angioplastied blood vessel open is becoming clotted.
''Of course, the most exciting possibility would be to develop drugs that our antibody fragments could transport to just the
clogged spots in those arteries, or in clogged stems -- drugs that can be 'turned on' by a burst of light or x-rays to the chest or
through an intravascular catheter,'' Mr. Snyder speculated. ''The result could be a non-invasive, 'roto-rooter' de-plaquing
procedure -- only a dream today, but a possibility in the future, as a result of our targeting-activation fragment therapy,'' he
concluded.
Immunomedics is a biopharmaceutical company focused on the development, manufacture and commercialization of diagnostic
imaging and therapeutic products for the detection and treatment of cancer and infectious diseases. Integral to these products
are highly specific monoclonal antibodies and antibody fragments designed to deliver radioisotopes and chemotherapeutic
agents to tumors and sites of infection. The Company's first product, CEA-Scan(R) for the detection of colorectal cancer, has
been approved in the United States, Canada, and Europe. The Company's second diagnostic imaging product, LeukoScan(R),
has been approved for sale in Europe for the diagnosis of osteomyelitis (bone infection). This product is presently under
regulatory review by the U.S. Food and Drug Administration. Immunomedics also has several other diagnostic imaging
products and two therapeutic products in clinical trials.
This news release, in addition to historical information, contains certain forward-looking statements that involve significant risks
and uncertainties. Such forward-looking statements are based on management's belief, as well as assumptions made by, and
information currently available to, management pursuant to the ''safe-harbor'' provisions of the Private Securities Litigation
Reform Act of 1995. Actual results could differ materially from those expressed in or implied by the forward-looking
statements contained herein. Among the factors that could cause or contribute to such differences include, but are not limited
to, inherent uncertainties accompanying new product development and marketing, availability of financing and other sources of
capital, actions of regulatory authorities concerning product approval, actions of government and private organizations
concerning reimbursement, the impact of competitive products and pricing, and the results of further clinical trials as well as
those discussed in the Company's Annual Report on Form 10-K for the year ended June 30, 1997. The Company undertakes
no obligation to release publicly the result of any revisions to these forward-looking statements that may be made to reflect
events or circumstances after the date of this release or to reflect the occurrence of other unanticipated events.
SOURCE: Immunomedics, Inc. |
