Antisoma PLC has adopted a new clinical programme around Therex, a product based on the humanised monoclonal antibody huHMFG1 aiming to treat breast cancer.
Originally developed by the Imperial Cancer Research Fund (ICRF), Therex is in a Phase I clinical study.
The antibody targets most common epithelial cancers, including breast, lung, ovarian, gastric and colorectal cancers.
Pre-clinical studies at Imperial Cancer Research Technology’s Applied Development Laboratory (ADL) have used a mouse breast cancer model to demonstrate improved survival for Therex-treated mice compared to untreated mice.
The ICRF Breast Cancer Biology Group, Guy’s Hospital is carrying out a Phase I clinical study to test the safety and tolerability of Therex following repeat administration.
Results from the eighteen patients with primary breast cancer treated so far indicate that the drug is well tolerated.
Antisoma will now progress Therex development into a Phase IIa clinical study and will contract with a third-party to provide clinical- grade material for the study, expected to start in the first half of 2001.
Antisoma’s Phase IIa study is likely to recruit those women who have relapsed following first-line treatment, of which there are approximately 112,000 cases each year.
Glyn Edwards, Antisoma’s CEO, said: “Recent advances in antibody therapy have given hope to about 30% of women who relapse following primary treatment for breast cancer. Therex could bring similar benefits to more women with this disease if it successfully completes clinical studies in the years to come.” He added “We have worked successfully in the past with the ICRF on our lead product Theragyn and we are very pleased to be working with them again on this new cancer product which we believe has substantial market potential. However, drug development is risky and there is no certainty that Therex will be successful.”