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Strategies & Market Trends : The Thread Formerly Known as No Rest For The Wicked -- Ignore unavailable to you. Want to Upgrade?

To: MARK C. who wrote (40189)	5/14/1999 1:26:00 AM
From: kathyh	Read Replies (1) \| Respond to of 90042

hi mark, just can't seem to get off the computer and into bed... you are right about fast track being 6 month approval, but sounds like the process will be two years... matrix will not submit application until 2nd half of 2000 per this article, and then 6 months for approval, would put product, if approved, on mkt. in early 2001... i guess my post was confusing regarding two years... sorry... now really going to sleep... sweet dreams, all... kathy :) Thursday May 13, 12:47 pm Eastern Time Matrix leaps on promised fast-review of cancer drug By Ransdell Pierson NEW YORK, May 13 (Reuters) - The share price of Matrix Pharmaceuticals Inc (MATX - news) more than doubled on Thursday after the U.S. Food and Drug Administration granted an expedited six-month review of the company's drug for head and neck cancer, IntraDose. Shares were up $4, to $6.75, in heavy trade on the Nasdaq exchange, where Fremont, Calif.-based Matrix was the second-most-heavily traded stock. Matrix said late Wednesday the FDA's willingness to review its lead cancer drug on a 6-month basis, as opposed to the agency's typical year-long review period for new medicines, would allow it to submit part of its application even before completing final pivotal clinical studies of IntraDose. Matrix said it hoped to complete submission of the application in the second half of 2000 after winding up two Phase III trials of the drug in patients with recurrent head and neck cancer who are considered incurable with surgery or radiation. IntraDose encapsulates the widely used anticancer agent cisplatin in an injectible collagen-based gel designed to deliver and retain high concentrations of the chemotherapy drug within a tumor. It also includes epinephrine, an agent that constricts blood flow and thereby helps localize chemotherapy at the tumor site. Douglas Adams, a pharmaceutical analyst for Davenport & Co in Richmond, Virginia, said Matrix became a ''very undervalued stock'' in 1996 when U.S. regulators rejected the company's drug AccuSite for treatment of genital warts. Adams said AccuSite had been rejected by the U.S. Food and Drug Administration because it caused swelling at the injection site, but he noted it is sold in some overseas markets. ''When AccuSite was rejected, some people began questioning the Matrix technology approach and the stock became very cheap,'' said Adams. Adams said he continued to believe, however, in the potential of the technology and continued to have a one-year price target on Matrix. He said conventional anticancer drugs are given systemically, typically by intravenous infusion, and thereby can cause serious side effects by delivering their toxic active ingredients to many organs and cells unrelated to the target tumor. ''With the Matrix technology, you inject the chemotherapeutic agent right into the tumor site and it is fairly localized. So you can use a higher dose of the chemo drug and hopefully have greater ability to shrink the tumor,'' he said. IntraDose is also being tested in Phase II studies of patients with primary and metastatic liver cancer. Analysts said IntraDose could have potential annual sales of about $100 million if approved for head and neck cancer, with potential revenues jumping to $300 million or more if it is eventually approved for liver cancer. --------------------------------------------------------------------------------