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Biotech / Medical : Depotech(depo) -- Ignore unavailable to you. Want to Upgrade?

To: John McCarthy who wrote (641)	12/21/1997 4:46:00 PM
From: chirodoc	Respond to of 887

L I G H T H O U S E.. .......thanks for your hard work!

To: John McCarthy who wrote (641)	12/21/1997 4:54:00 PM
From: chirodoc	Respond to of 887

Chiron Doesn't Win OK for Cancer Drug Lois Kazakoff, Chronicle Staff Writer .......from the local newspaper. interesting that they say "didn't reject it either." let's stay tuned to their meetings with fda/chiron. Chiron Corp. of Emeryville yesterday failed to win an expected approval for a cancer drug it is developing with San Diego-based DepoTech Corp. But the U.S. Food and Drug Administration advisory panel didn't reject it either. The panel did not vote on the drug because of lingering questions about whether the clinical trials included enough patients. The drug is DepoCyt, a new formulation of cytarabine, a drug used to fight neoplastic meningitis, a fatal disease of the brain and spinal cord caused by spreading cancer. ''We were a little bit surprised by this,'' said Chiron spokesman Jim Knighton. He said the FDA agreed five years ago to the design of the clinical trials. Only about 20,000 people in the United States are treated for the disease each year. ''We just don't have thousands of people in a trial so it's hard to get huge clinical significance.'' He added that company representatives will meet with DepoTech and the FDA to figure out the next step. DepoTech had no comment. Chiron's stock fell 44 cents yesterday to $18.13. Trading in DepoTech's shares was halted. Knighton said DepoCyt was seen as an improvement over existing treatments for neoplastic meningitis because it required fewer injections. ''And we saw a trend of superior performance over other treatments,'' he said. Analysts had generally dubbed DepoCyt as ''approvable'' and were surprised when it failed to win the FDA advisory panel's stamp of approval. A thumbs up from the panel for a new drug generally, but not necessarily, assures FDA approval to sell the drug in the United States. If approved, the drug was expected to have sales of $100 million to $200 million a year. Yesterday's setback comes a day after the full FDA approved another Chiron-developed product, Regranex. Made by Johnson & Johnson, Regranex is the first bioengineered treatment for healing diabetic foot ulcers.

To: John McCarthy who wrote (641)	12/22/1997 11:39:00 AM
From: biao luo	Read Replies (2) \| Respond to of 887

Thank you for the summary. I flipped through their publication packet. One question I had in mind is why they chose to use Depo-Ara-C (Depocyt) to treat NM from solid tumor? These are the reasons I came up with: 1. Depo-Ara-C has been studied by them from very early. Sinil Kim has been on all those papers. He is a MD, worked at UCSD for many years before he moved to Depo, I presume he is the scientific founder of the company. He worked on Depo-Ara-C on the assumption that the short half life of the drug limited its use in the central nervous system. 2. Since they had been developing Depocyt for a long time, they had better knowledge about this agent than anything else in their portfolio. So out of convenience, they chose it for solid tumor NM. 3. Their delivery system showed more impressive effects on Ara-C than methotrexate 4. Solid tumor NM is a bigger market. But I also came up some serious doubts about their logic: For NM from solid tumor, the standard of care is methotrexate. I don't know the histry how people arrived at this decision, but I would assume that different chemotherapies were tested, and using conventional drug delivery system, methotrexate was shown to be superior than all the other drugs (presumably including Ara-C) for solid tumor NM, while Ara-C was superior than all the other drugs (presumably including methotrexate). So there is a reason to believe that solid tumor NMs respond better to methotrexate than Ara-C. Then the company went to the ODAC, presented their data. But by presenting their solid tumor data, they were asking two questions: First, was their delivery system significantly improved than conventional one? Second, was Ara-C better than methotrexate in solid tumor NM? This is kind of comparing apples and oranges. They were asking the panel to decide on whether apples are better oranges without showing any overwhelming data. But in order to validate their delivery technology, they only needed to ask if Depo-oranges are better than plain oranges? For solid tumor NM, this plain orange is methotrexate, for leukemia and lymphoma, this orange is Ara-C. So if you don't really want to confuse the ODAC and maximize your chance of an approval, you should present data on Depocyt on leukemia and lymphoma NM with Ara-C control, or present data on Depo-methotrexate on solid tumor NM with methotrexate control. From their publications, they are also developing Depo-methotrexate, but it is far behind Depocyt. However, if you use Depo-methotrexate in solid tumor NM, you have less to prove to the ODAC. So I think the leukemia and lymphoma NM data will be critical. That should really be the focus and there are more reasons to believe that one should do better than Depocyt on solid tumor. If you side with ODAC on the data of Depocyt on solid tumor, they will need a lot of patients, a lot of money, a lot of explanation to reverse the decision. But for leukemia and lymphoma NM, it should be much simpler, albeit a smaller market. At this point though, the size of market is not a concern at all. They just need an approval to go forward.