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Biotech / Medical : EntreMed (ENMD) -- Ignore unavailable to you. Want to Upgrade?

To: Don Dorsey who wrote (1908)	4/15/1999 1:59:00 PM
From: Don Dorsey	Respond to of 2135

Celgene's thalomid designated for Crohn's WASHINGTON, April 15 (Reuters) - Celgene Corp. said on Thursday it had received orphan drug designation to develop its thalidomide drug for use against Crohn's disease, a chronic inflammation of the bowels. The drug, which is being used experimentally against a range of diseases from leprosy to cancer, is already being tested against Crohn's. But getting orphan drug designation from the U.S. Food and Drug Administration (FDA) gives the company exclusive marketing rights in the United States for seven years if it is approved for this use. The idea behind orphan drug designation is to give companies an incentive to develop drugs for use against rare diseases. Celgene is testing thalidomide, which it would market under the name Thalomid if approved, in Crohn's patients at Cedar's Sinai hospital in Los Angeles. The drug is approved for use against complications of leprosy, but Celgene believes its broad range of effects will make it useful in treating many conditions. "An overproduction of tumor necrosis factor alpha (TNF-a) can lead to severe inflammation in conditions such as Crohn's, rheumatoid arthritis and other autoimmune diseases," Dr. Jerome Zeldis, vice president of medical affairs for Celgene, said in a statement. He said thalidomide may be able to suppress TNF-a, which is an immune system compound. Thalidomide, which Celgene licensed from EntreMed is notorious for having caused horrific birth defects when pregnant women used it as a tranquilizer in the 1950s and 1960s. Celgene and the FDA developed severe restrictions for using and testing the drug to try to make sure no pregnant woman gets exposed.

To: Don Dorsey who wrote (1908)	4/16/1999 2:16:00 AM
From: marc ultra	Read Replies (1) \| Respond to of 2135

Even though you didn't ask for it I'll give you a long's point of view. Mouse endostatin had a remarkable anti-tumor effect on human tumors put on mice and a combination of endostatin and angiostatin was even more remarkable virtually curing the cancer. The NCI replicated the endostatin results after some technical problems. Before the replication the WSJ did a reverse hype and did an absurd trashing of the drugs and even Judah Folkman who most cancer researchers would agree will get a Nobel Prize for his work in tumor angiogenesis. The drugs are species specific and human endostatin as well as angiostatin have been shown to have anti-tumor activity in mice and should be even much more powerful in humans. Using a yeast expression vector recombinant human endostatin has been made in quantity by ENMD and its highly respected contract manufacturer Covance and Phase I trials have been scheduled to start at two cancer centers under NCI auspices probably in the fall as soon as protocols are written up and any further tests are done on the drug to be used. ENMD's human endostatin is soluble and appears to be stable and should be able to be given by IV infusion without problem. All of these patients will have advanced cancer so even tough phase I studies will be testing safety all the patients will be monitored carefully for tumor response as well as any side effects. As to Angiostatin ENMD is also able to produce it in the same yeast system and testing should begin at the end of the year. BMS was trying to produce angiostatin by another method which led to their difficulty in getting consistent product and their decision to drop it particularly as the individual who was most responsible and enthusiastic about it had left the company. In addition to this ENMD makes money off of all the thalidomide CELG is selling and has other products. If you look at these facts and realize that if the testing of endostatin several months down the road shows significant efficacy that this drug will run through trials and get approval in record time This story is real and compelling and one negative article from the WSJ in the past that has already proven incorrect since and then someone on SI who put out an absurd press release which misunderstood obvious facts to the contrary, this has the potential to be one of the greatest medical and investing stories in history. Obviously a failure in humans that can't be fixed or an unexpected severe side effect that can't be corrected could turn this into a failure Marc

To: Don Dorsey who wrote (1908)	4/16/1999 10:56:00 AM
From: Mama Bear	Read Replies (2) \| Respond to of 2135

Don, nothing like a little exaggeration in your characterization of the 'shorts' position. I can't recall anyone calling ENMD a scam or crooked. Nor do I recall anyone saying it was headed straight for bankruptcy. It's hard to have a rational conversation if the sides split into factions and hunker down on their opinions. The stock is speculative, and will continue to swing based on hopes and dreams. If the hopes and dreams become real, you will be well paid. The two major worries I'd have were I long this stock would be Bristol kicking them, and Folkman's penchant for self promotion. Sure, it's possible that Bristol made a mistake. But that's not a position that on which I'd want to bet. Usually when I find someone as promotional as Folkman I dismiss their company out of hand. I do find this situation a little different, as it's my impression that Folkman is serving his ego, rather than promoting worthless stocks for cash profits. Still, it could be the latter, and not something on which I'd like to take a chance. It's a mistake to characterize this company as a done deal either way. I'm not sure why marc ultra thinks that 'most cancer researchers would agree will get a Nobel Prize for his work in tumor angiogenesis.' This drug has by no means been proven in humans, and that's a long row to hoe. I only know one cancer researcher personally, and he's most skeptical of the potential. Any position in this company other than trading the price swings in the short term is gambling, IMO. Barb