News Release

Novel colorectal cancer trial seeking patient volunteers at leading U.S. cancer centers

Business Announcement

Cooney Waters Group, Inc.

Toronto, Canada (February 11, 2002) – Human research studies of a new treatment strategy for colorectal cancer using a therapeutic cancer vaccine technology have begun enrolling patients at several trial sites around the United States and Canada. The vaccine trial will enroll up to 90 patients with metastatic colorectal cancer not yet treated with standard chemotherapy, according to Aventis Pasteur Limited of Toronto, Canada, the study sponsor.

Clinical trial sites are presently established in New York City; Washington DC; Philadelphia; Los Angeles; Birmingham, AL; Chicago; Dunmore, PA; Vancouver, BC; and Ottawa, Ontario. For more information about specific study locations and eligibility, individuals should contact Aventis Pasteur Limited, in Toronto, Canada at the following toll-free phone number: 1-866/455-0349.

“The goal of the study is to determine if the vaccine, called ALVAC-CEA/B7.1, can activate the body’s own immune system to eliminate cancer cells that may not be eliminated with traditional treatment of metastatic colorectal cancer with the standard, first-line chemotherapy regimen,” said Dr. Neil Berinstein, Assistant Vice President Clinical Oncology, Program Director, Cancer, Aventis Pasteur. “We will be looking to see if the vaccine, combined with chemotherapy, allows a better outcome for patients than chemotherapy alone,” he added.

- more - The multicenter trial, which is considered a pilot Phase II study to assess safety and immunologic activity, will randomly assign patients to one of three active treatment groups.

One study group will be vaccinated with ALVAC-CEA/B7.1 before starting standard chemotherapy and will receive additional, concurrent doses of the vaccine with the chemotherapy. Patients in another group will receive the same regimen described above plus doses of tetanus toxoid to determine whether this additional compound further enhances the immune response. Patients in the third group will receive standard chemotherapy; patients in this group who achieve complete or partial responses will have the option of receiving ALVAC-CEA/B7.1 vaccine upon completion of the chemotherapy. Active treatment will require approximately 28-31 weeks, depending on to which group patients are assigned and how well individual patients tolerate the chemotherapy regimen.

Standard, first-line therapy for metastatic colorectal cancer involves combination chemotherapy with three agents: Camptosar (irinotecan or CPT-11), 5-fluorouracil and leucovorin.

Patients will be evaluated routinely for local and systemic adverse events immediately following treatment and at each follow-up visit. Immune response and efficacy measures for objective response and response duration will also be assessed at several pre-designated points during the treatment period and at the end of the study. The investigational vaccine and other ALVAC-based formulations have shown promise in early clinical studies of the vaccine as a single agent conducted by the U.S. National Cancer Institute, in collaboration with Therion Biologics of Cambridge, MA, which demonstrated that ALVAC-based recombinants are safe, with a non-overlapping toxicity profile to chemotherapy. In general, treatments were well tolerated, with no significant product-related toxicities. Side effects associated with the vaccine included mild, local reactions.

Novel Design Supports Concept of Therapeutic Vaccine

Typically, vaccines are designed to prevent diseases by preparing the immune system for a possible attack. With therapeutic cancer vaccines, the goal is to “turn on” the immune system of people who already have the disease, to increase the power of current treatments, such as chemotherapy.

The cancer vaccine under study is delivered via a live recombinant canarypox virus vector engineered to elicit specific immune responses for cancer immunotherapy. Alvac is a variant of the canarypox virus that produces a self-limiting infection that does not cause any harm or symptoms in humans, but causes infected cells to temporarily display tumor-associated antigens (TAA) linked to specific cancers. In response to these TAAs, the immune system becomes activated and attacks tumor cells that display the same TAA. It is designed to target the carcinoembryonic antigen (CEA), which is a TAA that is over-expressed in the majority of colorectal cancers.

Colorectal cancer is the most common cancer of the gastrointestinal tract and the second leading cause of cancer-related morbidity and mortality. There are approximately 300,000 new cases and 200,000 deaths in North America and Europe each year. An estimated 70% of patients are initially diagnosed with treatable forms of the disease, but 25% of these patients will still experience recurrence, which frequently leads to death due to metastatic disease.

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Aventis Pasteur is Canada’s largest vaccine manufacturer, and where the corporation’s global cancer vaccine program is anchored. The company is a leader in the research and development of vaccines for cancer. The trial is part of an up to $350-million, 10-year effort to find therapeutic vaccines against several common forms of cancer. The two leading targets currently are melanoma and colorectal cancer. Aventis Pasteur is working with Aventis Pharma on the evaluation of this novel therapeutic vaccine. Aventis Pasteur is the vaccine division of Aventis, a world leader in life sciences.

This release contains information about investigational products not approved for use. Statements in this news release other than historical information are forward-looking statements subject to risks and uncertainties. Actual results could differ materially depending on factors such as the availability of resources, the timing and effects of regulatory actions, the strength of competition, the outcome of litigation and the effectiveness of patent protection. Additional information regarding risks and uncertainties is set forth in the current Annual Report on Form 20-F of Aventis on file with the Securities and Exchange Commission.


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