News | July 19, 2000

Antisoma Set to Resume Clinical Trial of Ovarian Cancer Treatment

After a month-long delay, Antisoma plc (London) is resuming enrolment of new patients in a Phase III trial of the company's Theragyn product, a combination of a monoclonal antibody, HMFG1, and a chemical linker that binds to radioactive Yttrium-90. Antisoma is developing the product to eliminate residual ovarian cancer cells in the abdomen following surgery and chemotherapy.

Antisoma temporarily delayed enrollment in the study, also known as the SMART clinical trial, on May 22, 2000, after reviewing results of research conducted on a radiolabelled HMFG1 murine monoclonal antibody, which is similar to Theragyn. (This other study, however, was not a part of Antisoma's clinical program.) The decision was made as a precautionary measure to allow independent assessments of the data.

A SMART clinical trial Independent Safety Committee (ISC) then evaluated the independent assessments—which were made under the guidance of the Imperial Cancer Research Fund (ICRF)—as well as safety information available from the SMART clinical trial. Based on their evaluation, the ISC strongly recommended that recruitment into the SMART clinical trial be continued.

Plans to resume enrolment are being co-ordinated with the regulatory authorities, and study sites will enroll new patients as appropriate to their situation.

Theragyn comprises a monoclonal antibody, HMFG1, and a chemical linker that binds to radioactive Yttrium-90. HMFG1 recognises polymorphic epithelial mucin (PEM), an abnormal form of mucin produced by tumour cells of the epithelium, a membraneous tissue covering most of the body surface. Most solid tumors—such as those of the ovary, stomach, lung, and breast—are epithelial in origin. The antibody acts as a tumor-targeting vehicle, specifically delivering Yttrium-90 radioactivity to the PEM-expressing cells and destroying them.

Antisoma is a biopharmaceutical company developing novel products for the treatment of cancer. The company's strategy is to use our antibody development experience to produce safer and more effective tumor-targeting therapies for commercialization by pharmaceutical partners.

For more information: Antisoma plc, West Africa House, Hanger Lane, Ealing, London W5 3QR, UK. Tel +44-208-799-8200. Fax +44 208-799-8201.

Edited by Jim Pomager