Targon And Duke Cancer Center Sign $3.75 Million Agreement To Produce Advanced Anti-Cancer Drugs

January 20, 1998

CYTOGEN Corporation and the Duke University Medical Center announce the formation of a research collaboration between Targon Corporation and the Duke Comprehensive Cancer Center. The terms of the agreement call for Targon's provision of $3.75 million, over the next three years, to support research and further testing of advanced anti-cancer drugs.

Under the research agreement, one half of the funds are designated for drug/technology discovery grants that will support research on identified reagents/technologies that warrant continued research via clinical studies. The remaining portion of the funds will support pre-clinical and clinical trials of new compounds developed at Duke, or other institutions, which are currently identified as Investigational New Drug (IND) candidates.

The U.S. Food and Drug Administration grants IND designation based on results of pre-clinical research findings; an IND designation permits commencement of human clinical trials. As part of the agreement, Targon will be granted an option to license products and technology from directly funded programs.

Additionally, Targon will receive a right of first review of certain inventions in the field of cancer therapy made by Duke during the term of the agreement. Targon will have a period of exclusive review for such inventions. Both parties hope that Targon's early and exclusive review of new technologies will lead to additional interactions between Duke and Targon and to rapid development of commercially viable products for the oncology community.

"This remarkable agreement promises to significantly accelerate the progress of new cancer treatments from laboratory to clinic," said Ralph Snyderman, M.D., Chancellor for Health Affairs, Duke University Medical Center."Such collaborations between an industrial partner committed to rapid commercialization of life-saving treatments and a cancer center with a reputation for research excellence have proven critical to realizing the promise of new discoveries. We believe that we will provide not only an abundant source of new ideas, but also an effective pathway to clinical application of those ideas. Duke's Comprehensive Cancer Center offers a full spectrum of research excellence, including expertise in basic cancer biology, in pre-clinical laboratory testing of new compounds and finally in clinical testing," he said.

Michael Sember, Targon's Chairman and CEO, commented "This relationship is an important component to Targon's strategy of leveraging our resources as we become a recognized leader in the field of oncology product development."

Duke's Cancer Center is leading-edge from both research and patient care perspectives, and our access to this expertise and potential product opportunities provides significant value to our company."

Said Michael Colvin, M.D., Director of the Duke Comprehensive Cancer Center, "The last few years have witnessed enormous advances in basic cancer biology and the understanding of how normal cells transform into tumors. As a result, we now have more promising therapeutic leads than at any time in history, and we need to bring those therapies into the clinic for further evaluation.

Colvin continued, "However, such advances have come as funding to develop new treatments remains limited. Thus, the research support provided by Targon will enable our scientists to pursue pathways to new treatments that might not have otherwise been possible."

According to Colvin, examples of promising new approaches include "antiangiogenesis" drugs that strangle a cancerous tumor's blood supply and compounds that disrupt the biochemical "signal transduction" pathways within cancer cells that trigger their uncontrolled growth. Traditional anti-cancer drugs have operated much like explosive bombs: They attack cancer cells but also cause serious side effects throughout the body. The new generation of anti-cancer drugs is designed to operate more like snipers, precisely targeting cancer cells, with fewer deleterious effects on patients. Such pinpoint action means that clinical testing of new drugs requires more specific measures of performance.

"For example, Duke researchers will work to develop `surrogate markers' for more precise testing of new drugs. Since traditional anti-tumor drugs kill tumor cells, we expect to see them killing cancer cells fairly rapidly," Colvin explained. "But compounds that interrupt other pathways may not kill a tumor immediately, but rather cause it to shrink over time. The endpoint of such treatment is harder to judge, and we need new biochemical tests that tell us if the drug has successfully disrupted the intended pathway in the cancer cell, while not interfering with similar pathways in healthy cells. Targon's support will enable us to develop such necessary clinical measures."

The Duke Comprehensive Cancer Center became one of the one of the nation's first comprehensive cancer centers in 1972 under the National Cancer Act. It is recognized internationally for the treatment of all types of cancer and for its groundbreaking research into the genetic and molecular basis of cancer and for developing innovative cancer vaccines and drugs. More than 6,000 cancer patients are admitted to Duke each year, and cancer patients make more than 100,000 visits to outpatient clinics each year. The center is one of six in the U.S. designated by the National Cancer Institute as a Specialized Program in Research Excellence for breast cancer.

Targon Corporation is a joint venture between Elan Corporation, plc and CYTOGEN Corporation. The company was created in 1996 for the rapid development, registration, manufacturing and commercialization of anti-cancer drugs. Targon is currently structured as a subsidiary of CYTOGEN.

Elan Corporation, plc is a leading worldwide drug delivery and biopharmaceutical company with principal research and manufacturing facilities in Ireland, the U.S. and Israel.

CYTOGEN is a biopharmaceutical company engaged in the development, manufacture and commercialization of products for the targeted delivery of diagnostics and therapeutic substances directly to disease sites. CYTOGEN has received FDA marketing approval for three different anti-cancer compounds.

Duke University

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