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

To: Bluegreen who wrote (6932)	8/13/1998 2:19:00 AM
From: StockDoc	Read Replies (1) \| Respond to of 17367

Sorry for the complex analogy with cancer, or the gram+ sepsis example. I'll try to avoid those in the future; this confuses some people. I'm trying to get input from fellow potential investors this time: the share price starts to become quite attractive. Anybody out there? I've already got some really useful timeline info in the previous post. All others, i.e., those with technical notes on the drug, the disease, the market, dreams, etc., please refer to my previous posts (in the Spring).

To: Bluegreen who wrote (6932)	8/13/1998 2:24:00 PM
From: Bluegreen	Read Replies (1) \| Respond to of 17367

BERKELEY, Calif.-- February 27, 1997-The results from a 400-patient Phase II clinical trial in patients suffering hemorrhagic trauma (acute loss of blood) Neuprex(TM) is more effective than placebo in reducing the incidence of serious organ dysfunction, infections, and death. Product safety was also confirmed across the entire patient population, announced the product's developer, Xoma Corporation. Based on its preliminary review, the company believes the results support advancing Neuprex(TM) to a Phase III trauma study, which will be the second pivotal study for the product. The company is completing a comprehensive analysis of data from this trial which, with additional data from an ongoing trauma pharmacokinetics study, will be used in the pivotal trial design. "We've now completed successful Phase II Neuprex(TM) studies in two different indications," said Jack Castello, chairman, president and chief executive officer of Xoma. "Since hemorrhagic trauma is a complex disorder, we chose to run this large Phase II study in a broad patient population in order to obtain meaningful information about the drug's impact on this disorder. We are very confident that the results support advancing to Phase III." "In every study we've performed so far we have seen clear evidence of Neuprex's (TM) activity with no adverse events or safety concerns," stated Dr. Pat Scannon, Xoma's chief scientific and medical officer. "Data from this large, placebo-controlled study, plus the ongoing pharmacokinetics study, continues to augment an accumulating body of evidence regarding the effectiveness of our first BPI-derived product." Xoma investigators will present detailed data from the hemorrhagic trauma study in clinical publications and at future scientific meetings. The company is in the process of scheduling an end-of-Phase II meeting with the FDA. The randomized, double-blind trial, started in May of 1995, tested Neuprex(TM) in patients who received transfusions to replace blood lost through traumatic injuries, such as those suffered in auto accidents or gunshot wounds. At least 250,000 Americans annually sustain trauma severe enough to cause serious blood loss. If they survive the initial trauma and surgery, these patients face a significant risk of infectious complications including secondary infections, organ damage, and death. Research by Xoma scientists and collaborators suggests that these complications are triggered when gram-negative bacteria and their endotoxin (a toxic component of the bacterial cell wall) are carried into a patient's bloodstream from the gastrointestinal tract and other sources. Because Neuprex(TM) kills and neutralizes the bacteria and their endotoxin, it may prevent or mitigate these infectious complications. The recently completed study anticipated a range of responses to the drug depending on the nature and severity of injuries and amount of blood lost. Neuprex(TM) (recombinant bactericidal/permeability-increasing protein, also know as rBPI21) is the first product from Xoma's BPI drug development platform to reach clinical trials. BPI is a human host-defense protein that kills bacteria, neutralizes endotoxin on or released by these bacteria, and enhances the effectiveness of many antibiotics. In August 1996, based on the results of a 26-patient, open-label Phase II trial, Neuprex(TM) was granted a Subpart E designation by the FDA for treatment of meningococcemia, a deadly bacterial infection of children. A follow-on Phase III clinical trial is now underway at sites in North America and the United Kingdom. The Neuprex(TM) product is also in an ongoing 72-patient clinical trial to prevent infectious complications following partial hepatectomy (a type of liver surgery). Xoma has completed patient enrollment in a 21-patient pilot trial testing the product in combination with antibiotics to treat severe intra-abdominal infections. --------------------------------------------------------------------------------

To: Bluegreen who wrote (6932)	8/13/1998 2:30:00 PM
From: Bluegreen	Respond to of 17367

Last sentence is important in my opinion. The reason why I am putting basic information out is there seems to be basic questions asked. >>>>>>DALLAS, TX -- November 13, 1997 -- Giving patients extra doses of a protein that occurs naturally in the body may effectively treat meningococcemia, a frequently fatal childhood disease, researchers at the University of Texas-Southwestern Medical Center at Dallas report. In the Nov. 15, 1997 issue of The Lancet, Dr. Brett Giroir, assistant professor of pediatrics, and his colleagues report on using a recombinant form of bactericidal permeability-increasing protein (BPI) to treat children with severe meningococcemia, an infectious disease that strikes otherwise healthy children swiftly and without warning. Twenty percent to 50 percent of children with meningococcemia die, usually within 24 hours of the first symptoms. Those who survive the disease often develop gangrene (resulting in amputations), brain injury, developmental delays and emotional problems. The bacteria involved is the same gram-negative bacteria that causes meningitis. But instead of infecting the fluid around the brain and spinal cord, it infects the bloodstream, triggering an explosive inflammatory response throughout the body that can damage organs and cause shock. Penicillin and other antibiotics sometimes are effective in treating the disease, particularly in its early stages, but they often fail. "Many children have a bad outcome no matter how early the disease is caught," said Giroir, the Thomas Fariss Marsh Jr. Professor in Pediatrics. The protein used in the study is found in white blood cells. It acts early in an infection to kill gram-negative bacteria and neutralize their toxins, but there is not enough of it in the body to overcome the widespread infection caused by meningococcemia. The XOMA Corp. of Berkeley, CA., is developing bactericidal permeability-increasing protein-based products and testing them for a variety of uses in adults. The trial led by UT Southwestern was the first to study the drug Neuprex in children. Twenty-six meningococcemia patients between the ages of one and 18 were enrolled in the study at six medical centers. Only one patient died. "This compares with an expected mortality rate of 30 percent," Giroir said. "We are very encouraged with these preliminary results." While meningococcemia is rare, outbreaks have become more frequent in recent years. Texas has one of the highest rates of meningococcemia in the United States -- 1.2 cases per 100,000 residents. The disease is most prevalent in North Central and Northeast Texas. It usually occurs in mid-winter and early spring. A Phase III study of Neuprex is under way at more than 20 institutions in the U.S., Great Britain and Canada. The trial could lead to Food and Drug Administration approval of the drug. UT Southwestern also is starting a clinical trial of Neuprex in cystic fibrosis patients who have bacteria in their lungs that is resistant to antibiotics. "I anticipate that BPI will have many uses -- from treating general infections to treating complications of trauma," Giroir said.<<<<<<< --------------------------------------------------------------------------------