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Biotech / Medical : XOMA. Bull or Bear? -- Ignore unavailable to you. Want to Upgrade?


To: Bluegreen who wrote (12337)11/25/1999 5:53:00 PM
From: Tharos  Respond to of 17367
 
Antibiotic Resistance Investigations Indicate Both Good and Bad News
November 19, 1999
MedscapeWireBoth good news and bad news on the war against antibiotic-resistant bacteria: there may be a potent, new drug to combat bacteria resistant to existing antibiotics, but some strains of Staphylococcus aureus have become antibiotic-resistant globe trotters, spreading throughout the world. S. aureus is the most common bacterial cause of human diseases, including infections of the lung, bloodstream, heart valves, skin, and those infections caused by surgical wounds.

According to findings from researchers at the University of Iowa (UI), a novel synthetic drug linezolid was universally active against all tested forms of staphylococci regardless of resistance patterns to other antibiotics. The new drug also inhibited all enterococci and was 100% effective against streptococci.

"Linezolid appears to be a very promising new antimicrobial agent," said Ronald Jones, MD, a UI professor of pathology. "We have not found any documented cases where the drug has not been effective."

Jones and Michael Pfaller, MD, a professor of pathology and public health, will present their findings at the 37th Annual Meeting of the Infectious Diseases Society of America, to be held November 18-21, 1999, in Philadelphia. The researchers are the first team, besides the manufacturer Pharmacia & Upjohn, to test the effectiveness of the drug.

"One of the most exciting potential uses for this new agent is the management of resistant Gram-positive infections," Pfaller said.

That potential may be even more important considering the findings that UI colleague Daniel Diekema, MD, a pathology fellow and infectious diseases staff physician, will report at the same meeting.

According to the study led by Diekema, Pfaller, and Jones, similar and sometimes identical antibiotic-resistant strains of S. aureus are popping up hundreds and thousands of miles apart, even across oceans.

"We demonstrated that there are numerous instances where bacterial strains were present at many different hospitals in the same region and at hospitals on different continents," Diekema explained.

The medical community has been using antibiotics to treat bacterial infections for more than 60 years. However, many bacterial strains have become immune to most of the available drugs meant to destroy the organisms. Much of this immunity, or resistance, is due to overuse of the drugs themselves.

In the study, the Diekema and colleagues wanted to find out the genetic relatedness of antibiotic-resistant S. aureus strains in various areas of the world. The researchers also wanted to identify places where resistance was the highest. To conduct the probe, the team relied on the global network of 72 medical centers that participate in the SENTRY Antimicrobial Surveillance Program. The program is the first and only worldwide monitoring system for the spread, over time, of bacteria resistant to antibiotics.

"We did this particular study because it is very important to understand how these resistant strains are being spread around the world," Diekema said.

The findings, which showed that many of the resistant strains cross national borders and that the biggest resistance problem areas are located in Central and South America and in Asian-Pacific countries, are important as infectious disease control specialists attempt to combat the resistance, Diekema stressed.

"If resistance emerges within an individual hospital because of antibiotic use, then the best way to control that resistance is to crack down on antibiotic use," he said. "However, if very resistant strains are being spread widely between hospitals, then the best approach is to emphasize infection control practices. In the case of S. aureus, it looks like these resistant strains are very easily spread in hospitals, among hospitals, and even across continents. What that means to us is that even though antibiotic control is important for this bacteria, even more important probably are good infection control practices."
id.medscape.com



To: Bluegreen who wrote (12337)11/26/1999 1:45:00 PM
From: Cacaito  Read Replies (1) | Respond to of 17367
 
Blue, FDA does not pamper-diaper companies.

xoma was\is responsible for what research they undertake.

Fda will accept reasonable hypothesis, will assure that ethical issues are met, safety is number 1, and efficacy must be establish.

pII was a failure, they proceed to the debacle, not the FDA.

My point is forget trauma, is a failure. The patients with confirm blood culture about 1 in 20, will be candidates for bpi use anyway.

xoma did not try to screen candidates as per hypothesis, they went in a general way, they try to prevent organ failure, they assumed most organ damage was bacteria or lps (bacterial fragments). It is acceptable to try to prove hypothesis with treatment, it is just very expensive with a non proven drug like bpi, they could have wait for approval in meningo, they decided to go faster, fine, but pII was clear, no difference.

They should have screen the patients, and then prove that it work in septic infected ones, bpi is antibiotic, not blood replacement.

Blood replacement first 24 hours was 5 and 6 units, placebo/bpi respectively, total 9 and 8 units placebo/bpi respectively.

xoma was either heorically courageous trying in these very sick patients, or way out of base. Again, pII was clear, bpi did not work. Post hoc analysis (not pre establish, post trial) is very tricky, they got caught( naive, mismanaged, choose

Move on, just realized that instead of 500,000 subjects a year it will be 25,000 (5 times the meningo group anyway), the ones infected, still a significant market.

Maybe another 25,000 more patients from non-hemorraghic trauma.

Back to wait for meningo.

Waste was xoma's endeavor:

From 1997 till now,
$25 M private placement (and nasty convertibles),
$18 M from IDEC, another
$18M from Sutro (more shorting),
$10 M from Allergan (hopefully Allergan has the money force to eye/bpi),
?$millions for psoriasis from DNA (the money also force to that specific development),
some money was used to pay Incyte.

Take the first three items, $61 millions (take half of that just for trauma, most for the pIII)

Waste is the name, not the FDA.

Result from 25 million shares to 50 million shares, a full 100% dilution!!!