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Biotech / Medical : Pharmacyclics (PCYC) -- Ignore unavailable to you. Want to Upgrade?

To: Gordon James who wrote (503)	8/30/1999 5:57:00 PM
From: Biomaven	Read Replies (1) \| Respond to of 717

Gordon, I was also puzzled by the difference in reported results with the earlier release. Only significant difference I could see is that the earlier results were measured by IVUS (which I think is supposed to be better) rather than by repeated angiograms. There's lots they didn't say here. Just what does "improved" mean when talking about the standardized measurements? Was there a dose-related effect? I'm trying to get hold of the presentation, which might answer some of the questions. The company is in registration, so don't think we'll get much comment from them. I'm not surprised that the Phase II has 2 dose arms - it's too much to hope for that you are going to find the optimum dose in a Phase I. Overall, this still looks fairly promising, though. Standard angioplasty often can't be used here at all as the obstructions aren't localized, and there also seems to be a significant problem with restenosis. Thus I'm pretty convinced that Antrin will eventually find at least a respectable niche here, if not significantly more. Peter

To: Gordon James who wrote (503)	8/30/1999 6:05:00 PM
From: Gordon James	Read Replies (1) \| Respond to of 717

Roto-rooter P.S... Of course, as a PhaseI study, this study wasn't designed to prove anything regarding efficacy, but I suppose there are folks forming early opinions and trading based on what we have seen so far. Bloomberg ran a story yesterday that scooped the press release, and it contains some additional comments by the investigator: quote.bloomberg.com Pharmacyclics Plaque-Buster Drug Seems Safe in 43-Patient Study Barcelona, August 29 (Bloomberg) -- Pharmacyclics Inc.'s light-activated drug, Antrin, appears safe and could someday offer a new way for doctors to open clogged blood vessels without injuring them, a study of 43 patients suggests. Procedures now used to unclog arteries, such as angioplasty, can cause small damage to the vessels. These injuries may trigger processes in the body that lead to new build-ups of plaque that clogs the arteries, a process known as restenosis. Antrin is an injected drug designed to break up plaque when it's exposed to light through a fiber-optic cable threaded into the clogged artery. If it proves effective, the treatment will be the first to clear clogged vessels without removing plaque buildup by force. ``Antrin is like nothing I've ever seen,' said Paul Kramer, a Kansas City, Missouri-based cardiologist who presented the results of the Antrin study at the European Society of Cardiology's annual meeting. The conference, one of the world's largest gatherings of heart specialists, drew more than 16,000 doctors to Barcelona. Antrin is one of three drug candidates that Pharmacyclics, a small, money-losing company with no approved products on the market, is testing in people. Further along is an experimental breast-cancer treatment. Shares in the Sunnyvale, California-based company, which focuses on light-activated drugs, have more than doubled to 33 1/4 in the past 12 months. The company also presented early data on the light-activated therapy in November at another of the world's largest gatherings of cardiologists, the annual American Heart Association meeting. Kramer, a cardiologist for more than 20 years, said he has also tested cardiac devices for companies such as Boston Scientific Corp. ``There's really nothing to compare to this,' he said of the Antrin study. Advanced Tests The work Kramer presented comes from an initial study, intended to determine first if a treatment is safe. Pharmacyclics is about to begin a more advanced test of Antrin, intending to enroll 375 patients in a year, said Kramer, who said he doesn't own stock in Pharmacyclics. Of the 43 patients in the initial study, 14 showed a more than 10 percent improvement in widening of the diameter of the arteries 28 days after treatment, Kramer said. Antrin therapy involves a 5-minute infusion of the drug, which can be done at a doctor's office. ``It's a green color, it looks like antifreeze,' Kramer said. ``It would make a great special effect for a movie.' The day after the infusion, the patient returns for the fiber-optic procedure to activate the drug. In the more advanced study, Antrin will be used along with angioplasty to treat clogs in arteries in the lower body and legs, he said. In angioplasty, doctors insert a thin balloon- tipped tube into the clogged artery and then inflate the balloon to push back plaque to allow more blood to flow through. Patients enrolled in the new study will have at least two clogged arteries, Kramer said. One will be treated with Antrin therapy alone and the other with Antrin therapy and angioplasty, Kramer said. Light to Energy Antrin is naturally attracted to a fatty protein that's found in abundance in arterial plaque and accumulates only in the blockages. It belongs to a family of chemical compounds known as Texaphyrins for the Texas researchers who discovered them. Texaphyrins are synthetic versions of naturally occurring compounds that exist in small amounts in all living tissue and act to convert energy. Like chlorophyll, which converts sunlight into energy in plants, Antrin also converts a certain wavelength of light into energy, which is what breaks up plaque deposits.