BERKELEY, Calif.--(BW HealthWire)--Sept. 24, 1997--XOMA
Corporation (NASDAQ:XOMA) today announced results of an interim
analysis of data from the first 65 patients in a Phase III pivotal
clinical trial testing its Neuprex(TM) product as a treatment for
pediatric patients with severe meningococcemia, a rare but deadly
infection that primarily affects children.
The independent Data Safety Monitoring Board (DSMB) which
reviewed the data (including 60-day follow-up on these 65 patients) recommended continuation of the trial and found no evidence to suggest any safety concerns. The 200-patient, randomized, placebo-controlled trial has enrolled more than 80 patients to date
at 17 medical centers in North America and the United Kingdom.
"We are pleased that this interim analysis has supported continuing the trial," said Jack Castello, chairman, president and CEO of XOMA. "We have now treated more than 500 patients with Neuprex(TM) in Phase I, II and III clinical trials with no known safety problems. This is a remarkable cumulative safety record for a multi-activity anti-infective product."
Meningococcemia is a deadly infectious disease that occurs when
the bacteria Neisseria meningitidis, which also cause meningitis,
infect a victim's bloodstream. The bacteria and their endotoxins
(poisonous components of the bacterial cell wall) can trigger a
systemic inflammatory response in patients that can progress within hours from a flu-like disease to shock, organ damage, tissue
necrosis, and death.
Neuprex(TM), has multiple activities against meningococcemia:
it kills gram-negative bacteria; it binds to bacterial endotoxins,
resulting in their clearance and neutralization; and it enhances the
potency of many antibiotics.
An open-label pilot clinical study, completed in 1996, treated 26
severely ill meningococcemia patients with Neuprex(TM); 25 survived
the disease. Under a Subpart E designation granted in August 1996
by the Food and Drug Administration to expedite the evaluation of
the product for this indication, XOMA began the ongoing pivotal
trial at centers in the United States and Canada in October 1996.
In January 1997, the first UK study center was added. Data from the pilot study were presented in March 1997 at a scientific conference in Munich, Germany. Erika Kirsch, MD, an investigator in the study, compared the results with historical data from 55 patients treated at the same medical centers in the two years before the study. The death rate in the Neuprex(TM) trial was 3.8% (one death in 26 patients) compared to a historical case fatality rate of 22% (12 deaths in 55 patients), and survivors treated with Neuprex(TM) fared better on standard measures of overall disability, compared to patients in the historical study.
XOMA is conducting Neuprex(TM) studies in humans in multiple indications. The start of a Phase I study in cystic fibrosis
patients was announced September 22, 1997. A Phase III trial in
patients suffering severe hemorrhage 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). Data from a 21-patient pilot trial
testing the product in combination with antibiotics to treat severe
intra-abdominal infections are in analysis.
XOMA Corporation is a biopharmaceutical company developing
products for the treatment of infections, infectious complications
of traumatic injury and surgery, and immunological disorders. The
company is focused on accelerated development of products derived
from BPI (bactericidal/permeability-increasing protein). BPI is a
human host-defense protein with multiple anti-infective properties. It was discovered in 1978 by Peter Elsbach, M.D., Professor of Medicine, and Jerrold Weiss, Ph.D., Professor of Microbiology, at New York University School of Medicine.
XOMA has collaborated with NYU since 1991 to extend and apply
BPI-related research to the commercial development of pharmaceutical products. Neuprex(TM) is an injectable systemic formulation of rBPI(21) and the first product from XOMA's BPI drug development platform to reach clinical trials. Additional BPI-derived products in development include I-PREX(TM), a topical formulation of rBPI(21) to treat ophthalmic infections, and Mycoprex(TM), an antifungal peptide product to treat systemic fungal infections.
This press release contains certain forward-looking statements
that involve a number of risks and uncertainties. Such statements
are based on the company's current beliefs as to the outcome and
timing of future events, and actual events or 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 of the company's
collaborative relationships, and future actions by the U.S. Patent
and Trademark Office, as well as the risk factors listed from time
to time in the company's SEC reports (including but not limited to
its report on Form 10-Q for the quarterly period ended June 30,
1997, as well as its Annual Report on Form 10-K for the year ended
December 31, 1996), may affect the actual results achieved by the
company.
Note to Editors: For a copy of this or other recent releases
call: XOMA Fax News On Demand 800/901-7788.
CONTACT: XOMA Corporation
Ellen M. Martin, 510/644-1170 or 800/BIO-XOMA
xoma.com |
