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Biotech / Medical : Techniclone (TCLN) -- Ignore unavailable to you. Want to Upgrade?

To: shero who wrote (3478)	3/17/2000 9:14:00 PM
From: Jim Mills	Read Replies (1) \| Respond to of 3702

BIG SET BACK FOR TCLN!! Techniclone Warns of Setback in Trials of Lead Drug Candidate Techniclone Warns of Setback in Trials of Lead Drug Candidate Tustin, California, March 17 (Bloomberg) -- A Techniclone Corp. executive warned that changes in testing plans for its most- advanced drug candidate are likely to delay development of the non- Hodgkin's lymphoma treatment by six to eight months. John Bonfiglio, Techniclone's interim president, said in an interview that a decision by development partner Schering AG to test its Oncolym drug in a so-called Phase I/II study will delay its clinical development, though it will eventually make the product more productive. ``It's a setback,' he said. ``We're six to eight months behind where we thought we'd be.' Tustin, California-based Techniclone is already lagging behind two other biotechnology companies, Idec Pharmaceuticals Corp. and Coulter Pharmaceutical Inc., in a race to win approval for a new type of injected treatments for non-Hodgkin's lymphoma that direct radiation to tumor cells. The biotechnology company, whose stock has soared 14-fold this year, said yesterday in a filing with the Securities and Exchange Commission that Schering AG has decided on the additional study to review the drug's safety and give some evidence of its effectiveness. Techniclone had previously said Oncolym was about to enter a Phase II trial, a test that would have focused on evaluating the drug's effectiveness and dosage. The Competition Idec Pharmaceuticals has said it expects to file for approval of its Zevalin treatment during the fourth quarter of this year. Coulter Pharmaceutical has already completed Phase III testing of its Bexxar drug and is now preparing to file for U.S. Food and Drug Administration approval. All three experimental treatments are antibodies designed to seek out tumor cells in patients with non-Hodgkins lymphoma, then dose them with radiation from a radioactive isotope attached to the antibody. Last year, German drugmaker Schering AG entered into a license agreement with Techniclone to help develop Oncolym. Schering then decided to stop a Phase II/III trial of the drug, saying it wasn't satisfied with the way the drug was administered, according to Bonfiglio. The original trials of the drug called for patients to receive three injections, a process that proved to be too cumbersome and expensive, Bonfiglio said. The new Phase I/II trial, which Techniclone said will begin with 18 patients in the second quarter of this year, will look at giving the drug to patients in just one dose, Bonfiglio said. ``The only way we would be competitive with the drug is to do what we're doing,' Bonfiglio said. ``In the long run, it will make the drug more competitive and be better for us.' Another reason for returning to Phase I testing is that Techniclone and Schering have changed the manufacturing process for the drug and therefore would need to conduct a new safety trial to determine the product's maximum tolerated dose, Bonfiglio said. ``We've improved the process, increasing the antibody manufacturing yield to at least 10-fold of what it was before,' Bonfiglio said. ``And we've also improved the process by which we attach the radioactive isotope.' Techniclone shares fell 1 25/32 to 8 1/16.