Harry A. Arena (investor)
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Arthur V. Boyce Jr. (media)
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Targeted Diagnostics & Therapeutics, Inc. Expands Cancer Test Targets
– PA Biotech Company Develops Esophageal and Gastric Cancer Markers –

West Chester, PA – October 31, 2002 -
Targeted Diagnostics & Therapeutics, Inc. (TDT), which last year announced the development of powerful diagnostic and therapeutic technologies for colorectal cancer, is now broadening its sights to include gastric and esophageal cancers. A new research study, published in the August issue of Cancer Epidemiology, Biomarkers & Prevention, demonstrates that the Company’s GC-C technology, which has generated great excitement in the fight against colorectal cancer, may also be employed as a sensitive and specific diagnostic marker and as a therapeutic target for cancers of the stomach and esophagus.

The study was conducted by a research team at Thomas Jefferson University in Philadelphia, PA, led by Scott A. Waldman, M.D., Ph.D., Samuel M.V. Hamilton Professor of Medicine and Director of the Division of Clinical Pharmacology at Jefferson Medical College. Waldman’s new research has demonstrated that when cells lining the esophagus and stomach begin the process of transformation to cancer (called metaplasia), they assume the molecular characteristics of intestinal cells and express a protein called guanylyl cyclase-C (GC-C). Using a molecular testing technique, GC-C was detected in tumors from 100% of the esophageal cancer patients and 89% of the gastric cancer patients in the study. Consequently, the study indicates that GC-C expression in the esophagus and stomach may be used as a sensitive and specific diagnostic marker and as a target for gastric and esophageal cancer.

According to Waldman, “We’ve known for some time that GC-C could be used for diagnostic and therapeutic applications for colorectal cancer. Now we are excited that the results shown in this preliminary study confirm the presence of GC-C in gastric and esophageal metaplasia. There are a number of possible applications. GC-C can be used alone for detecting the presence of the cancer or in conjunction with its related ST ligand to deliver imaging or chemotherapy agents directly to the cancer cells.”

The addition of gastric and esophageal cancer diagnosis and treatment continues to affirm the utility of GC-C as a major new weapon which TDT is bringing to the war against cancer. The American Cancer Society estimates that in 2002 there will be 21,600 new cases of stomach cancer and 12,400 deaths. For esophageal cancer, the American Cancer Society estimates 13,100 new cases and 12,600 deaths. Application of the GC-C technology for earlier diagnosis and more effective treatment could be a significant new milestone in the fight against these cancers. Moreover, the applications could be even broader. There are approximately 20 million Americans who experience chronic heartburn, which can lead to gastroesophageal reflux disease (GERD), and about 2 million Americans have a condition known as Barrett’s Esophagus, a pre-malignant condition of the esophagus. TDT is working on determining how the expression of GC-C might play a role in diagnosing and treating these conditions.

Leading up to this study, Dr. Waldman’s research team developed extensive clinical evidence concerning the use of GC-C for the detection and treatment of colorectal cancer. That research has shown that GC-C is expressed only on cells lining the intestine of healthy people and on the surface of colorectal cancer cells, when detected outside the intestine. Studies have established that GC-C is not found on normal healthy cells outside the intestine and, its detection in blood or lymph nodes is a definitive marker for colorectal cancer. Diagnostic blood and lymph node tests currently under development at TDT show a degree of accuracy, sensitivity and specificity, surpassing any other tests on the market today. The tests are so sensitive that they can detect 1 colorectal cancer cell in 10,000,000 normal cells.

From 1982 through 1994, Mr. Gathman was Vice President - Finance and Chief Financial Officer of SunGard Data Systems Inc., a global leader in integrated IT solutions for financial services and the pioneer and leading provider of information availability services. (NYSE: SDS). He had responsibility for all financial operations and investor and shareholder relations. Mr. Gathman participated in SunGard’s initial public offering, a secondary offering, a convertible debt offering and numerous acquisitions.

The Waldman team has also established extensive clinical data demonstrating that GC-C binds to a bacterial protein called the “heat-stable enterotoxin” (“ST”), which can be employed as a highly specific probe for the receptor, permitting its exploitation for the targeted delivery of imaging or chemotherapy agents directly to metastatic cancer cells. The prospect of targeting and delivering chemotherapy agents only to cancerous cells, but not to the surrounding normal healthy cells, has long been an objective of pharmaceutical companies around the world. In December, 2001, TDT granted to Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM), an exclusive world-wide license to use TDT’s technology to develop human cancer therapies targeting GC-C and utilizing the ST ligand to deliver them. Millennium intends to employ the technology to develop both toxin and antibody-based therapeutics directed against colorectal and other cancers.

Targeted Diagnostics & Therapeutics, Inc.
TDT is a biotechnology company with a substantial intellectual property portfolio and a commitment to research in the area of discovery and development of molecular-based technologies for the targeted detection and treatment of cancer, infectious diseases, and gastrointestinal disorders. Since its inception in 1994, TDT has been successful in developing highly specific novel diagnostic markers and therapeutic targets for gastrointestinal malignancies including colon, rectal, gastric, and esophageal cancer. In addition to the technology for therapeutics targeted to colorectal cancer being licensed to Millennium, TDT has developed a highly sensitive and specific molecular marker for detecting metastatic colorectal cancer cells in lymph nodes and in blood. These new diagnostic tools, currently undergoing Phase I human clinical testing, will be used for staging patients with colorectal cancer, and for detecting the recurrence of cancer in the blood of patients undergoing postoperative surveillance for this disease. Headquarters for TDT are located in West Chester, Pennsylvania, along the Route 202 biotechnology corridor.

Editor’s Note: This release is available on TDT’s website at