News

May 08, 2001
ImmunoGen Begins Enrollment in a Third Phase I/II Human Clinical Study with Lead Product for Colorectal, Pancreatic and Non-Small-Cell Lung Cancers

CAMBRIDGE, Mass., May 8 /PRNewswire/ -- ImmunoGen, Inc. (Nasdaq: IMGN) today announced that it has begun enrollment for a third Phase I/II human clinical study with huC242-DM1/SB-408075, its lead Tumor-Activated Prodrug (TAP) for the treatment of colorectal, pancreatic and certain non-small cell lung cancers.

This study is designed to evaluate huC242-DM1/SB-408075 in a more dose- intensive regimen, and is being conducted at the Institute for Drug Development of the Cancer Therapy and Research Center (CTRC) in San Antonio, Texas, under the direction of Anthony W. Tolcher, M.D. and Eric K. Rowinsky, M.D.

"We and our development partner, GlaxoSmithKline, are very excited about the potential for this product," said Mitchel Sayare, Ph.D., Chairman and CEO of ImmunoGen, Inc. "With the previously-reported, safety and pharmacokinetic profile of the product, this study is designed to explore the tolerability of the product in a more dose-intensive regimen. GlaxoSmithKline continues to proceed on schedule with its clinical development plan."

Additional data from the first Phase I/II human clinical study, in which the safety and pharmacokinetic profiles of huC242-DM1/SB-408075 were evaluated on a once-every-three-week dosing schedule, will be presented at the 2001 Annual Meeting of the American Society of Clinical Oncology (ASCO) in San Francisco on May 13. This study was also conducted with Drs. Anthony Tolcher and Eric Rowinsky as Principal Investigators.

Another Phase I/II human clinical study, designed to evaluate the safety of huC242-DM1/SB-408075 when administered on a weekly regimen, is ongoing at the University of Chicago Cancer Research Center under the direction of Richard L. Schilsky, M.D.

TAP Technology
ImmunoGen developed its Tumor-Activated Prodrug, or TAP technology to address the therapeutic need for improved cancer therapies by delivering highly potent cytotoxic agents directly to tumor cells with minimal harm to healthy tissue. Each TAP product is comprised of a highly potent small molecule effector drug which is 100- to 1000-fold more potent than existing chemotherapeutics conjugated to a tumor-targeting monoclonal antibody. The TAPs are designed to act as prodrugs and remain nontoxic while circulating in the body, only activated once they are inside the target cell. In preclinical studies, TAPs have shown therapeutic efficacy and complete cures at doses with no clinical signs of toxicity [ RVJ Chari et al., Proceedings of AACR, 39:4382(1998)].

HuC242-DM1/SB-408075 is a TAP created by conjugating the cytotoxic maytansinoid drug DM1 with the humanized monoclonal antibody huC242.

About ImmunoGen, Inc.
ImmunoGen, Inc. develops innovative biopharmaceuticals, primarily for cancer treatment. The Company has created potent Tumor-Activated Prodrugs, known as TAPs, consisting of drugs coupled to monoclonal antibodies for delivery to and destruction of cancer cells. Besides GlaxoSmithKline, the Company has collaborative arrangements with Genentech, Abgenix, British Biotech, MorphoSys, Avalon, Raven, and Millennium.

This press release includes forward-looking statements based on management's current expectations. Factors that could cause future results to differ materially from such expectations include, but are not limited to; the success of the Company's research strategy; the applicability of the discoveries made therein; the difficulties inherent in the development of pharmaceuticals, including uncertainties as to the timing and results of preclinical studies; delayed achievements of milestones; reliance on collaborators; uncertainty as to whether the Company's potential products will succeed in entering human clinical trials and uncertainty as to the results of such trials; uncertainty as to whether adequate reimbursement for these products will exist from the government, private healthcare insurers and third-party payors; and the uncertainties as to the extent of future government regulation of the pharmaceutical business.

Contact:
Donna L. LaVoie.
V.P., Corp. Comm. & Investor Relations
ImmunoGen, Inc.
617-995-2518
http://www.immunogen.com

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