November 21, 2002.
Onyx (NASDAQ: ONXX) and Bayer’s (NYSE:
BAY) BAY43-9006 demonstrated preliminary safety and antitumor activity profiles in phase I investigation in the management of various advanced, refractory cancers including those of the colon, rectum, liver, breast, and ovary. Phase II investigations of BAY43-9006, an oral therapeutic that probably functions by inhibition of the map kinase protein “raf,” were initiated in September 2002.
The phase I data, presented at the European Organisation for Research and Treatment of Cancer (EORTC), National Cancer Institute (NCI) and American Association for Cancer Research (AACR) 2002 Symposium on Molecular Targets and Cancer Therapeutics, show that BAY43-9006’s adverse effect profile is reassuring. In addition, some anecdotal evidence suggests efficacy. 27 of 114 high-dose BAY43-9006 recipients remain on the compound with disease that has not progressed after more than six months. 7 study subjects remain on BAY43-9006 for more than one year without disease progression. The most compelling anecdotes are those of a patient with a previously reported partial hepatocellular carcinoma response who has remained on BAY43-9006 therapy without progression over nine months and a patient with a partial renal cell carcinoma response who was on BAY43-9006 for 44 weeks before disease progressed.
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