Vasogen approved to start CLL trial in Canada

[Guest guest]

Vasogen Receives Regulatory Approval to Commence

Clinical Trial in Chronic Lymphocytic Leukemia

(http://www.vasogen.com/040501.html)

(http://www.sunnybrookandwomens.on.ca/)

(This has been publicized before here.)

Vasogen Inc today

announced that it has received approval from Health

Canada to proceed with a

clinical trial to assess the safety and efficacy of

its immune modulation

therapy in patients with chronic lymphocytic leukemia

(CLL). CLL is a serious

form of cancer affecting approximately 120,000

individuals in North America

and Europe.

The CLL trial is being conducted under the

direction of Dr. Spaner,

clinical oncologist, Sunnybrook and Women's Health

Sciences Centre, University

of Toronto. The study will enroll up to 22 patients

with symptomatic CLL. The

endpoints that will be measured throughout the

duration of the study include

reduction in circulating CLL cells, tumor bulk, and

safety parameters.

" Current treatment strategies to control

symptomatic chronic lymphocytic

leukemia are unfortunately limited to intervention

with toxic chemotherapeutic

agents, " said Dr. Spaner, principal investigator for

the study.

" Given that

the malignant B-lymphocytes involved in CLL appear to

have escaped normal

immune regulation, we would expect Vasogen's immune

modulation therapy to be

beneficial. We have recently observed very encouraging

clinical responses in

patients receiving this treatment modality. "

Chronic lymphocytic leukemia is characterized by the

proliferation of

malignant B-lymphocytes in the blood, bone marrow, and

lymph tissue, causing

enlargement of the lymph nodes, spleen and liver, bone

marrow dysfunction, and

significantly weakening the immune system. Patients

with CLL experience

numerous disease-related symptoms including fatigue,

weight loss, anemia,

bleeding disorders, and increased infections.

Late-stage CLL patients have a

median survival of less than three years. At present

CLL is incurable, with

conventional chemotherapeutic agents being used mainly

for palliation of

symptoms. These agents have serious adverse side

effects, including

suppression of bone marrow function, nausea, vomiting,

and increased risk of

infection. Approximately US$300 million is spent

annually on therapies for

CLL.

In addition to CLL, Vasogen is advancing the clinical

development of

immune modulation therapy for the treatment of a

number of autoimmune and

inflammatory conditions, including psoriasis,

peripheral vascular disease,

congestive heart failure, ischemia/reperfusion injury,

and graft-versus-host

disease.

SOURCE Vasogen Inc.

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