Thursday March 26, 11:28 am Eastern Time
Company Press Release
SOURCE: Immunomedics, Inc.
Austrian Surgeon Tells Cancer Specialists They Can Cure
More Rectal Cancer Patients if They Monitor Them with
CEA-Scan(R)
SAN DIEGO, Calif., March 26 /PRNewswire/ -- More than 100,000 patients whose colorectal cancer ''recurs'' each year after surgery may have a ''second chance'' for a cure -- if their doctors follow them with CEA-Scan (Arcitumomab), a nuclear imaging study developed by
Immunomedics, Inc. (Nasdaq: IMMU - news), instead of depending upon a CT, colonoscopy or blood tests.
These are the conclusions from a paper presented by Austrian surgeon Professor Peter Lechner at the joint meeting of the Society for Surgical Oncology and World Federation of Surgical Oncology Societies in San Diego. Professor Lechner followed 40 consecutive patients with
different stages of rectal cancer using CT, colonoscopy and CEA-Scan -- and found that CEA-Scan was the most helpful in finding potentially curable patients.
''CEA-Scan helped us increase by a factor of four our ability to find recurrent rectal cancer while it was still potentially curable,'' reported Peter Lechner, MD, FACS, chief of the Department of Surgery, City Hospital of Kosterneuburg, Austria. ''And after an average of 22
months following surgery, the patients we operated on were all alive and apparently tumor-free.''
''By imaging patients with CEA-Scan every six months during the first two years after their surgery, and then every 12 months until five years had passed, we picked up four times more patients curable with a second operation than without this new nuclear imaging study,'' explained Professor Lechner. During the same period, among 40 tougher-to-cure rectal cancer patients, Professor Lechner's team found and apparently cured six patients, guided by CEA-Scan.
More than 50,000 Americans/year experience recurrent colorectal cancer
Each year, more than 140,000 Americans undergo surgery for cancer of the colon or rectum. Unfortunately, about 40% will experience a recurrence within two years. Because CT, colonoscopy and blood tests aren't very sensitive to the early signs of recurrence, only about a
third of patients with recurrent colorectal cancer are candidates for a second operation ... and of those that get one, only about a third actually experience long-term absence of disease.
In January, surgeons from Flinders Medical Centre, in Adelaide, Australia, writing in the American Journal of Gastroenterology, reported that CT, colonoscopy and chest X-rays, procedures used for standard patient monitoring worldwide, had not proven useful in detecting curable recurrences of colorectal cancer. The Australian surgeons studied 325 patients with these techniques for five years -- and found just one curable patient.
CEA-Scan ''method of choice in the detection of recurrences''
In Professor Lechner's study, 16 of 40 patients developed 22 surgically-confirmed recurrences (tumors at the site where cancer had been earlier removed) and/or metastases (tumors that spread via the blood or lymphatic system to other organs). CT identified three out of seven (43%)lymph node metastases and all three liver metastases. Among nine extraluminal presacral recurrences (tumors outside the bowel, in the pelvis), CT detected three for sure; another three were 'questionable.''
By comparison, CEA-Scan identified five out of seven (71%) lymph node metastases, and two of three liver tumors. With eight true positive results in nine (89%) presacral recurrences, CEA-Scan was significantly superior to CT. One critical pelvic tumor was exclusively found by CEA-Scan.
''We conclude that CEA-Scan is the method of choice in the detection of recurrences after rectal cancer surgery,'' Professor Lechner said.
CEA-Scan(R) (pronounced C-E-A) enables doctors to take pictures of small tumors that have spread beyond the main tumor in the bowel itself. These small tumors -- called ''metastases'' -- have been difficult for previous medical imaging studies to pick up, and often elude detection by the surgeon during the operation to remove the bowel tumor. CEA-Scan takes its name from carcinoembryonic antigen, or ''CEA,'' a protein normally expressed by ''embryonic'' human tissue in the early weeks after conception. Solid malignant tumors, like those of the colon, breast, lung, and female reproductive system, express CEA.
CEA-Scan carries a mild radioactive isotope to these elusive metastases ... sticks to them ... and in effect ''lights them up'' on the computer screen of a conventional nuclear camera. Patients are
scanned about three hours after injection, and findings are available the same day.
Result: Improved chance that surgeons can find otherwise ''invisible'' tumors in the liver and lymph nodes -- remove them, or schedule courses of radiation or chemotherapy to kill them -- and thus, improve the patient's chances for a cure or prolonged survival.
Researchers at Immunomedics realized that the body's antibody defense system was a perfect model for a diagnostic system to pick up hidden tumors. The only problem was that normal human antibodies don't attack tissue that expresses CEA. And so, they developed their own antibodies
that do target cells that express CEA. Those antibodies form the basis of CEA-Scan ... and also, an experimental cancer-treatment agent Immunomedics calls ''CEA-Cide(TM).'' CEA-Cide will deliver to tumors cancer-killing radioisotopes many times stronger than those used for imaging in CEA-Scan. Immunomedics is conducting clinical trials with CEA-Cide in different cancer types.
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. |
