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Strategies & Market Trends : Anthony @ Equity Investigations, Dear Anthony, -- Ignore unavailable to you. Want to Upgrade?

To: QuietWon who wrote (19325)	3/10/1999 6:11:00 PM
From: zx	Read Replies (2) \| Respond to of 122087

nice article that points to the potential of imcl. Tuesday March 9, 10:05 pm Eastern Time ImClone starts final trial of cancer drug By Maggie Fox, Health and Science Correspondent WASHINGTON, March 9 (Reuters) - A small biotechnology company said on Tuesday it had started final trials of a new cancer drug that has so far shown good results in patients. New York based ImClone (Nasdaq:IMCL - news) said it had received the go-ahead from the U.S. Food and Drug Administration (FDA) to start Phase III trials of the drug, which is the final stage before seeking approval. As a result of the green light from the FDA, Germany's Merck KgaA, which signed an agreement with ImClone in December to distribute the drug in Europe, gave ImClone a $5 million ''milestone'' payment. The drug, known as C-225, is a monoclonal antibody -- a genetically engineered version of a natural body chemical that can home in on cancer targets. The only other monoclonal antibody now on the market for cancer is Herceptin, made by Genentech (NYSE:GNE - news), which is licensed for use against breast cancer. ''Like Herceptin, it targets epidermal growth factor (EGF) receptors,'' Dr. Samuel Waksal, president and chief executive officer at ImClone, said in a telephone interview. Herceptin targets the human epidermal growth factor-2 (HER-2) gene, while C-225 targets HER-1 or EGF, which Waksal says is involved in a wide range of cancers. ''The market for our product is much larger,'' he said. ''Fully one-third of all human solid tumors express the EGF receptor.'' These include cervical cancer, non-small cell lung cancer, some types of pancreatic cancer, and squamous cell cancers of the head and neck. Waksal, a former immunologist, said cancer cells use EGF to escape standard chemotherapy or radiation treatments. ''What happens with a lot of these tumors is they use the EGF receptors to turn themselves on to cause replication,'' he said. ''They make their own growth factor, stimulate themselves to divide their way out of damage.'' What C-225 does is work along with radiation or drugs. They stop the cells from dividing at one point in their life cycle, while C-225 attacks replication at a second point. In Phase II trials last year, C-225 along with radiotherapy killed all the tumors in 13 of 15 patients, and caused a 50 percent regression of the tumor in two more. ''Normally you would expect a 40 percent response rate in this population,'' Waksal said. Phase III trials will involve 416 patients at 25 places in the United States and Europe who have Stage III or IV squamous cell cancers that cannot be removed surgically. Half will get radiotherapy and C-225 and half will get radiotherapy alone. Waksal is confident, although the Phase II trial was a very small one. ''For the past 50 years people have used toxic agents in ever-increasing doses to try and kill tumors,'' he said. He hopes to be able to use lower doses along with agents such as C-225 to ''drive these cells down a death pathway.'' Merck KGaA, which is unrelated to Merck & Co of the United States, will develop and commercialize C225 outside North America. ImClone retains any North American rights.