Yea! XOMA is about to start phase I for treatment of antibiotic resistance in CF and is "analyzing data" from a pilot study in severe abdominal infections. This is terriffic news for the start of what may be the biggest application of BPI. Of course, who knows how the market will react?
Ed
=======
XOMA Begins Clinical Program in Cystic Fibrosis Patients to Test
Neuprex Against Antibiotic-Resistant Infections
Business Wire - September 22, 1997 08:34
XOMA %CALIFORNIA %MEDICINE %BIOTECHNOLOGY %PRODUCT V%BW P%BW
Jump to first matched term
BERKELEY, Calif.--(BW HealthWire)--Sept. 22, 1997--XOMA Corporation (Nasdaq:XOMA) today announced a new clinical study for Neuprex(TM), part of a clinical program investigating the use of the product to treat bacterial lung infections in cystic fibrosis patients, including those where the bacteria may be antibiotic resistant.
Cystic fibrosis (CF) patients experience recurring severe lung infections ("exacerbations"). With repeated antibiotic treatments, infecting bacteria can become resistant to most antibiotics. Neuprex(TM), when combined with antibiotics in laboratory tests, makes strains of bacteria that commonly infect CF patients more susceptible to antibiotics. Therefore, XOMA is evaluating Neuprex(TM) as an adjunctive treatment, to be used with conventional antibiotic therapy for exacerbations in cystic fibrosis patients.
"This clinical program with XOMA will help lead to new weapons to defend CF patients against exacerbations, especially in cases where the bacteria become resistant to multiple antibiotics," said Dr. Robert Beall, president and CEO of The Cystic Fibrosis Foundation. "By enhancing the susceptibility of bacteria to antibiotics, Neuprex(TM) could be a potentially important addition to our arsenal."
XOMA has recently completed a 40-patient "natural history" study, to obtain laboratory data on the effect of Neuprex(TM) on organisms collected from CF patients. The new study will enroll up to 24 CF patients hospitalized for acute bacterial exacerbations at a major university-affiliated CF center. If this pilot study, the first to use Neuprex(TM) in cystic fibrosis patients, demonstrates that the product is safe in these patients and has acceptable pharmacokinetics (absorption, distribution and biological availability), then XOMA plans to follow up with placebo-controlled efficacy trials.
Cystic fibrosis (CF) is a fatal genetic disorder found in 1 of 3300 births (about 60,000 patients in the U.S. and Europe). The genetic defect alters chloride transport in cells of the lungs, pancreas and intestines, resulting in an accumulation of viscous mucus which, among other symptoms, promotes recurring infections. Repeated severe lung infections eventually lead to respiratory failure and death. Until recently, most CF patients died in childhood; improved treatments have increased the average lifespan to approximately 31 years.
Exacerbations usually involve multiple bacterial strains, including gram-negative bacteria such as Pseudomonas aeruginosa, and are characterized by severe inflammation and elevated levels of bacterial endotoxins (poisonous components of gram-negative bacteria). Neuprex(TM) kills gram-negative bacteria and binds to endotoxins, resulting in their clearance and neutralization. Neuprex(TM) also enhances the activity of antibiotics. Therefore it represents a unique multi-pronged approach to treating CF flare-ups.
Studies of Neuprex(TM) against antibiotic-resistant bacteria in CF patients may also help XOMA understand how Neuprex(TM) might be more widely applied to treat multi-drug resistant (MDR) infections. These infections are a growing medical problem, especially in hospitalized and immunocompromised patients. Antibiotic resistance is an important area of research for XOMA, and also for the U.S. Food and Drug Administration (FDA). Pat Scannon, MD, PhD, XOMA's chief scientific and medical officer, discussed issues in the development of anti-infective products to combat MDR in microbes at an open meeting of the FDA's Anti-Infective Drugs Advisory Committee in July 1996.
The cystic fibrosis study brings to five the total number of indications in which XOMA has conducted studies of Neuprex(TM) in humans. A Phase III pivotal trial for treatment of meningococcemia, a deadly bacterial infection in children, is ongoing under FDA Subpart E designation at sites in North America and the United Kingdom. A Phase III trial in patients suffering severe blood loss due to trauma is planned to start this fall. XOMA is completing a Phase II trial testing Neuprex(TM) to prevent complications following partial hepatectomy (a type of liver surgery). XOMA is analyzing data from a 21-patient pilot trial testing the product in combination with antibiotics to treat severeintra-abdominal infections.
The Cystic Fibrosis Foundation is a voluntary, non-profit health organization. Its mission is to develop means to cureand control CF while improving the quality and duration of life for those with the disease today.
XOMA Corporation is a biopharmaceutical company developing products for the treatment of primary infections andmajor complications due to infectious diseases, traumatic injury and surgery, as well as immunological disorders. Thecompany is focused on the accelerated development of products derived from BPI. BPI is a human host-defense proteinwith anti-infective and anti-angiogenic properties. The molecule was discovered in 1978 by Peter Elsbach, M.D.,Professor of Medicine, and Jerrold Weiss, Ph.D., Professor of Microbiology, both at New York University School ofMedicine. XOMA has collaborated with NYU since 1991 to extend and apply BPI-related research to the commercial development of pharmaceutical products. Neuprex(TM) (also known as rBPI21) is the first product from XOMA'sBPI drug development platform to reach clinical trials. Additional BPI-derived products in development includeI-PREX(TM), a topical formulation for treatment of ophthalmic infections, and Mycoprex(TM), an antifungal peptideproduct for treatment of systemic fungal infections.
This press release contains certain forward-looking statements that involve a number of risks and uncertainties. Suchstatements are based on the company's current beliefs as to the outcome and timing of future events, and actual eventsor results may differ materially from the company's expectations. In addition to matters described in the press release,results of pending or future clinical trials, actions by the U.S. Food and Drug Administration, changes in the status ofthe company's collaborative relationships, and future actions by the U.S. Patent and Trademark Office, as well as therisk factors listed from time to time in the company's SEC reports (including but not limited to its report on Form 10-Qfor the quarterly period ended June 30, 1997, as well as its Annual Report on Form 10-K for the year ended December31, 1996), may affect the actual results achieved by the company.
For a copy of this or other recent releases call: XOMA Fax News on Demand 1-800-901-7788. XOMA website: xoma.com . Cystic Fibrosis Foundation: www.cff.org .
CONTACT: XOMA Corp.
Ellen M. Martin, 510-644-1170 or 1-800-246-9662 |
