Greg,
As of April 8, 60 patients were enrolled out of a planned 240.
The Oxo Chemie web site has been re-designed recently. Actually I think the re-design may still be in progress.
oxochemie.com
The following news release appears on that site. I don't think it has been posted here before:
Canadian Sites Approved for Phase 3 Clinical Trial of WF10, an Innovative
Immune Approach for Advanced HIV Disease
SOUTH SAN FRANCISCO, Calif. (April 8, 1999) OXO Chemie Inc., a subsidiary of
OXO Chemie AG of Switzerland announced today the April 6 approval by the Health
Protection Branch for the initiation of Canadian sites as the expansion of an ongoing U.S.
Phase 3 clinical trial for people with late-stage HIV disease. The study is a randomized,
double-blind, placebo-controlled trial of 240 late-stage AIDS patients that investigates the
effects of WF10 on survival, progression of AIDS, and prevention of opportunistic
infections. The drug is intended as adjunctive therapy to current combination antiretroviral
and opportunistic infection prophylaxis regimens. Approximately 60 patients are now
enrolled at United States sites. The review of the Investigational New Drug Submission by
the Canadian authorities was completed within 60 days, as specified in the "Food and
Drug Regulations." Following this review, they notified OXO Chemie to proceed with this
clinical trial in Canada.
OXO Chemie Inc., the Macrophage Company of South San Francisco, is developing the
investigational drug WF10, an immune therapeutic that targets macrophage function. The
U.S. company launched the Phase 3 study on the heels of encouraging results from Phase
2 clinical results published by the University of California, San Francisco that showed
WF10 was well-tolerated and revealed positive changes in new immunologic factors
thought to relate to slowing HIV disease progression.
Results from an earlier well-controlled clinical trial at Vanderbilt University in Nashville,
TN were published in the journal Infection (August 1998). The study indicated that AIDS
patients receiving WF10 experienced a lower frequency of opportunistic infections, fewer
hospitalizations, and longer survival.
In the Phase 3 study, the drug is being additionally tested for possible augmentation of the
cellular immune response in patients receiving standard HIV treatment, including highly
active antiretroviral therapy (HAART). Scientists are particularly interested in determining
WF10¹s effects in conjunction with antiretroviral therapy because its proposed mechanism
of action targets macrophages, a known reservoir of the HIV virus in AIDS patients. In
addition, in these late-stage patients the macrophages remain the last viable component of
the immune system.
The ongoing trial is expected to enroll patients from more than 30 key medical centers and
universities in North America. Patients participating receive treatment for an 11- week
period with follow-up periodically for up to two years.
OXO Chemie Inc., the Macrophage Company, is pursuing the clinical development of
treatments for diseases that are thought to be related to inappropriate macrophage
function. The active ingredient in WF10 is a chemically stabilized chlorite matrix called
tetrachlorodecaoxygen (TCDO). WF10 was developed by OXO Chemie AG, a
Swiss-based discovery and development company and is manufactured by OXO Chemie
GmbH in Germany. It is currently under clinical development for life threatening and
chronic inflammatory/autoimmune diseases.
OXO Chemie is an innovative, international company aimed at developing drug therapies
to treat serious and life-threatening conditions. Dimethaid Research Inc. of Toronto,
Canada is a 20 percent shareholder of OXO Chemie AG.
For further information, contact us at info@oxochemie.com |
