Mark, et al,
unless I'm mistaken it appears that Oxo's August 8th NR announcing full enrollment of the phase III trials, has been removed from the Website. May have been some information in the NR that they were uncomfortable with.
I suspect it might be the part were Kuhne mentions that they are going to show the unblinded results to the FDA. Maybe that was giving up too much information to the public? Any thoughts.
For your convenience, here is the NR:
WF10 Press Release
Tuesday August 8, 2:19 pm Eastern Time
Press Release
OXO Chemie Reports Full Enrollment in WF10
Phase III Clinical Trial for Late-Stage HIV Disease:
Researchers Present Encouraging Preliminary Safety
Data
SOUTH SAN FRANCISCO, Calif.--(BW HealthWire)--Aug. 8, 2000--OXO Chemie today completed enrollment in its
Phase III clinical trial of WF10. The multicenter, randomized, double-blind, placebo-controlled study enrolled more than 240
late-stage HIV patients (no more than 50 CD4 cells/mm3) at 30 clinical sites in the United States and 5 in Canada.
``We are all very grateful to have mastered the significant challenge of recruiting seriously ill patients to this placebo-controlled
study. Our objective is to provide evidence for excellent safety and substantial clinical benefit for individuals with very
advanced HIV disease. A blinded interim analysis of this trial will be conducted soon and presented to the FDA,'' stated Dr.
F.-W. Kuhne, founder of OXO Chemie. ``We would like to thank the patients, investigators, their research coordinators, and
those who care for these patients. We would also like to thank the dedicated people of PAREXEL International, a Clinical
Research Organization (CRO). Finally, we thank our partners at Dimethaid Research, Inc. who have helped us fund this
venture and provided constant support.''
The primary clinical objective of the multicenter, double-blind, placebo-controlled trial is to evaluate the safety and efficacy of
WF10 in 240 patients with CD4+ cell count less than or equal to 50 cells/mm3. Baseline mean viral load of this cohort of
patients has been >500,000 copies/mL, well above the therapeutic ideal of 'undetectable'. Baseline mean CD4+ count was 27
cells/mm3. Adverse events (AEs), serious adverse events (SAEs), hospitalizations, and death define safety and are typical of
the clinical events associated with this late stage of disease and are reflecting quality of life. Efficacy is defined by death or an
occurrence of any new AIDS-defining illness, according to the definition of the Centers for Disease Control (CDC).
A June 29, 2000 poster at the Vaccine Development and Immunotherapy in HIV Conference in Palm Beach, Florida
presented blinded data on the safety of WF10 in the Phase III trial and reiterated the rationale for WF10 in HIV Disease. The
lead author, Dr. D.T. Jayaweera of the University of Miami, along with co-authors Dr. Stephen Green of Hampton Roads
Medical Specialists, Dr. Melanie Thompson of the AIDS Research Consortium of Atlanta, Dr. Kathleen Squires of University
of Alabama in Birmingham, et. al., reported that ``patients with less than or equal to 50 CD4+ T cells/mm3 receiving standard
of care therapy are at risk for the progression of disease or death. Data from in vitro studies show that WF10 causes profound
changes in T cell function via modification of macrophage activation.'' A preliminary analysis of in vivo gene expression in
macrophages from patients treated with WF10 indicates changes in elevated expression of several inflammatory genes
potentially related to T cell activation (McGrath, Meuer, under publication review). In conjunction with HAART, WF10
regulation of macrophage function by downregulation of inappropriate T cell activation may provide a unique approach in the
management of HIV disease that is not dependent on inhibition of virus replication.
``WF10's safety profile in the current Phase 3 study is very encouraging. Clinical experience indicates the administration of
WF10 is not difficult,'' said Dr. Jayaweera. The Independent Safety Monitoring Board (ISMB) reviews safety information,
including adverse events, serious adverse events, and other clinical data. The ISMB has formally met four times since the study
commenced. As of June 2000, a total of 1,068 AEs were reported. In addition, 154 SAEs resulting in 932 hospitalization days
and 18 deaths were disclosed. The ISMB Chairman, Calvin Cohen, M.D. of the Community Research Initiative of New
England, expressed no safety concerns to-date and confirmed that all reported serious adverse events have been reviewed.
This comment refers to a series of Phase II pathogenesis studies with WF10 at P. San Francisco General Hospital involving
HIV-infected patients (Khan, J. et. al. and Herndier, B. et. al., 12th World AIDS Conference, 1998). Researchers
demonstrated a highly elevated level of pro-inflammatory cytokine activity and lymphocyte markers including CD38+CD8+
cells, a link to AIDS lymphoma and AIDS dementia as features of the ongoing immune dysfunction. Production of these
elevated pro-inflammatory markers is under the control of functioning macrophages and the levels of these markers were
downregulated by WF10 in a dose-dependent fashion, suggesting that WF10 is one of the first drugs addressing this serious
immune deficiency aspect of HIV/AIDS. A review by McGrath and Kodelja (Pathobiology. 1999; 67-277-281) advances the
hypothesis of ``Balanced Macrophage Activation'', and its role in the pathogenesis of AIDS and other chronic infections and
immune disorders. In more recent work, McGrath and Meuer (publication in review), using highly advanced gene expression
techniques, analysed in vivo gene expression in macrophages from patients treated with WF10 and detected potentially
beneficial changes in expression of several genes related to inflammatory activation of CD4+ T-cells.
OXO Chemie, one of the founding companies of the Heidelberg Technology Park, has offices in South San Francisco
(California, USA), Fribourg (Switzerland) and Bangkok (Thailand). The company maintains manufacturing facilities in
Wanzleben (Germany). OXO Chemie is a pioneer developer of chlorite-based drugs.
The company's lead drug, WF10, is approved for use in Thailand under the name IMMUNOKINE(tm) for patients with
postradiation chronic inflammatory diseases including cystitis, proctitis, and mucositis. The company is sponsoring ongoing trials
for cancer in the U.S., Germany, and Thailand and for hepatitis C in Hong Kong and Germany.
WARNING: The information contained in this press release contains forward-looking statements. The Company's activities
and actual results may differ significantly from possible results. Based on current expectations, the Company assumes no
obligation to update this information. |
