Pfizer Starts Ph III Trials Of TLC-D99
Two Phase III clinical trials in breast cancer patients have begun with TLC-D99 (liposomal doxorubicin), a product being jointly developed by The Liposome Company and Pfizer.
One trial will compare the product with conventional doxorubicin while the other will compare a combination of TLC-D99 plus cyclophosphamide to conventional doxorubucin plus cyclophosphamide. Both are intended to support a New Drug Application to use the agent as a first-line therapy for metastatic breast cancer.
The companies noted that while non-liposomal doxorubicin is one of the world's most widely-used chemotherapeutic agents, its usefulness is limited by side effects such as irreversible toxicity. Worldwide rights to the product have been licensed to Pfizer by TLC and product development is a joint responsibility.
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