Xcytrin Posts Preliminary Results from Phase II Trial in CLL

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Pharmacyclics Announces Presentation of Preliminary Results

Evaluating Xcytrin for the Treatment of Chronic Lymphocytic Leukemia

SUNNYVALE, Calif., March 11 /PRNewswire-FirstCall/ --

Pharmacyclics, Inc.

(Nasdaq: PCYC) today announced the presentation of preliminary

results from

its ongoing, recently initiated, Phase 2 trial evaluating Xcytrin®

(motexafin gadolinium) Injection as a single agent for the treatment

of

relapsed chronic lymphocytic leukemia (CLL) at the International

Congress of

Hematologic Malignancies being held in Whistler, British Columbia,

Canada,

March 10-13.

The presentation entitled, " Motexafin Gadolinium in Hematologic

Malignancies, " outlined early data from an ongoing study evaluating

Xcytrin

for the treatment of recurrent CLL. Eleven patients, each who had

failed

several prior treatment regimens for the disease, were given Xcytrin

daily for

five days every three weeks for two cycles or until disease

progression.

Although it is early in the trial with several patients still

undergoing

treatment and evaluation, anti-tumor activity has been observed in

several

patients based on regression of involved lymph nodes and spleen and a

decrease

in circulating tumor cells in the blood. Based on these results,

Pharmacyclics plans to expand its trials in CLL and other non-

Hodgkin's

lymphomas to additional centers.

The trial results to date indicate that Xcytrin treatment has

been well

tolerated with no evidence of hematologic suppression. One patient,

with

widespread disease and lymphomatous involvement of the small bowel,

experienced a tumor response related complication. This patient

developed a

perforation of the small bowel caused by regression of the tumor in

the bowel

wall. This complication is seen often in patients with lymphoma

involving the

bowel that responds to treatment. The patient recovered uneventfully

and has

no evidence of disease progression after two cycles of therapy.

About Chronic Lymphocytic Leukemia and Non-Hodgkin's Lymphoma

CLL and non-Hodgkin's lymphomas are malignancies of lymphoid

cells.

CLL primarily involves the bone marrow and blood. Tumor cell growth

in these

patients usually causes an elevation of peripheral blood white cell

counts,

and infiltration of bone marrow, lymph nodes, spleen and other organs.

Patients with CLL are typically treated with chemotherapy or

monoclonal

antibodies. Although patients often respond to initial therapy,

ultimately

all patients relapse. Relapsed CLL is not curable and patients become

resistant to standard therapies.

Non-Hodgkin's lymphomas are usually widely disseminated at disease

presentation commonly involving multiple lymph node sites, the bone

marrow,

and other organs. Although they often respond to initial

chemotherapy, most

patients with relapsed B-cell non-Hodgkin's lymphomas are not cured

with

existing treatments.

About Xcytrin

Xcytrin is the first in a class of investigational drugs called

texaphyrins, which are rationally designed small molecules that have

a unique

way of working inside diseased cells. Following administration,

Xcytrin

selectively localizes and accumulates inside cancer cells, due to

their high

rates of metabolism where it induces programmed cell death by

generating

reactive oxygen species. Previous preclinical studies have

demonstrated that

lymphoid malignancies are particularly sensitive to reactive oxygen

species.

Because Xcytrin is a paramagnetic compound, its presence is visible

with MRI.

Studies with MRI have confirmed the selective localization of Xcytrin

in

primary and metastatic tumors.

Pharmacyclics is currently conducting an international pivotal,

randomized

Phase 3 clinical trial designed to compare the effects of whole brain

radiation therapy (WBRT) alone to WBRT plus Xcytrin for the treatment

of brain

metastases (cancer that has spread to the brain from another part of

the body)

in patients suffering from non-small-cell lung cancer (NSCLC). This

trial,

known as the SMART trial, will enroll 550 patients at leading medical

centers

in the United States, Canada, Europe and Australia. Pharmacyclics has

been

granted Fast-Track status by the U.S. Food and Drug Administration

(FDA) for

Xcytrin® (motexafin gadolinium) Injection for the treatment of brain

metastases in NSCLC patients. Xcytrin also is currently under

investigation

in several Phase 1 and Phase 2 clinical trials in various cancers

evaluating

its use as a single agent and in combination with chemotherapy and/or

radiation therapy.

SOURCE Pharmacyclics, Inc.

Web Site: http://www.pcyc.com