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Biotech / Medical : Imclone systems (IMCL) -- Ignore unavailable to you. Want to Upgrade?

To: 5,17,37,5,101,... who wrote (450)	3/17/1999 2:51:00 AM
From: REM55	Respond to of 2515

To All: Individual Investor article: Stocks & Funds Get Quotes, News and Analysis Ticker Symbol Search Home COMMUNITY Message Boards Stocks A-Z IIONLINE RESEARCH Stock of the Day Our Stock Picks Analysis & Opinion Archives Industry Reports Mutual Funds Insider Trading News PORTFOLIOS Your Portfolio Magic 25TM INDI SmallCap 500TM Trading Floor EDUCATED INVESTOR Investor UniversityTM 401(k) ForumTM I.I. Magazine SUBSCRIPTIONS Individual Investor Magazine Free E-Mail Account Free Newsletter RESOURCES E-commerce IIOnline Bookstore Investor Relations Fast, Free Info HELP Contents Your Account Log In Log Off Fun Stuff Industry Analysis Biotech Industry Archives UPDATE: ImClone's Best Days Still to Come Analyst: Bob Hirschfeld ImClone (NASDAQ: IMCL) shares rose 35% on March 10 after the company said the FDA will advance C225, ImClone's lead cancer therapeutic, to Phase III clinical trials. Shares were recently trading at $13.38, a 34% increase from when we recommended ImClone last month at $10.00. Click here to read original piece. Do we see further upside ahead for ImClone? You bet. C225, a monoclonal antibody, "inhibits tumors by signaling growth receptors, which stops tumor cells from dividing," said Imclone CEO Samuel Waksal. C225 targets EGF (epidermal growth factor) receptors, which are associated with tumor growth in a number of cancers, among them renal cell and pancreatic, and high percentages of patients with lung and colorectal cancers. The upcoming Phase III pivotal trials will evaluate the effect of C225 in combination with radiation in 416 patients with advanced squamous cell head and neck cancer. Waksal said enrollment in the trial will take about one year, and there will likely be a year of follow up. In a best case scenario, Waksal sees " a marketable drug as soon as 18 months from now." An earlier Phase II study of C225 demonstrated strong results. Used in combination with radiotherapy, 13 of the 15 C225-treated patients experienced 100% tumor regression, and the two other patients showed 50% regression. These trials involved patients who had failed via a straight chemotherapy or radiotherapy regimen, and for whom a combination radiotherapy treatment with C225 led to great results. We asked Waksal whether this could be another case of good Phase II, and lousy Phase III trials. Waksal answered "We tried C225 in combination with major chemotherapies and with radiotherapy, and, even in cases where the expected response rate is zero, we're still getting about 60%-level responses. So, we're very comfortable we've shown efficacy." In December 1998, ImClone and marketing partner Merck KGaA said they would share the license to C225, with Merck KgaA holding rights outside North America and ImClone retaining North American rights. Pursuant to the Merck KGaA agreement, ImClone receives up-front fees, cash-based milestones, and equity-base milestones and a $30 million credit to build out the manufacturing capacity to commercially produce C225. In fact, the FDA approval of C225 ImClone also has other developmental cancer compounds, such as anti-cancer vaccine BEC2, which targets small cell lung cancer and is in Phase III multinational trials, and its anti-angiogenic agent, anti FLK-1/KDR, which is currently in pre-clinical trials. What's more, during 1999, ImClone will also initiate other studies with C225 to support further indications for its powerful anti-tumor compound. We told the ImClone story on IIOnline on February 22. We cited the Merck KgaA agreement and mentioned that Jim McCamant of the Medical Technology Stock Letter believes that ImClone shares will reach between $60 and $150 by 2002. Bottom Line: It's reassuring that the company is meeting its expected timetable for developing C225, and we think that what was already a good story has become even better.