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Phase 1/2 Trial of Motexafin Gadolinium Plus Antibody


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SUNNYVALE, Calif., June 5 /PRNewswire-FirstCall/ -- Pharmacyclics, Inc.

(Nasdaq: PCYC) today announced final data from a Phase 1/2 study showing a 46

percent complete response rate in patients with multiply recurrent

non-Hodgkin's lymphoma (NHL) who were treated with motexafin gadolinium (MGd,

Xcytrin®) in combination with Yttrium-90 Ibritumomab Tiuxetan (Zevalin),

an approved antibody-targeted radiation therapy. The data were presented

during the 10th International Conference on Malignant Lymphoma being held this

week in Lugano, Switzerland.

The Phase 1/2 study was conducted in 29 patients with advanced relapsed

lymphomas, including 11 patients with aggressive lymphomas. Eighty-three

percent of the patients were rituximab (Rituxan®) refractory. Patients were

treated with a standard dose of Zevalin administered with 2.5 to 5.0 mg/kg of

MGd given for six days. Of 28 evaluable patients, 46 percent showed a complete

response and 11 percent showed a partial response for an overall response rate

of 57 percent. Rituximab refractory patients showed an overall response rate

of 86 percent, with a 64 percent complete response rate and a median time to

progression of 14 months. Adverse events seen were related to bone marrow

suppression, an expected side effect of treatment with Zevalin.

"Motexafin gadolinium has been shown to have single agent activity in

lymphoma and is synergistic with radiation therapy. This study shows a high

rate of durable complete responses, especially in rituximab refractory

patients," said Andrew M. Evens, D.O., M.S., Department of

Hematology/Oncology, Northwestern University Feinberg School of Medicine, and

lead author of the study.

Pharmacyclics has been developing MGd for use in combination with

radiation therapy for treatment of brain metastases from lung cancer. A

previous phase 3 trial showed that the addition of MGd to whole brain

radiation therapy (WBRT) improved the median time to neurologic progression

from 10.0 months to 15.4 months (P=0.12). At the 2007 American Society of

Clinical Oncology Annual Meeting (ASCO), Pharmacyclics announced final results

from a Phase 2 clinical trial in patients with brain metastases indicating

that MGd improved the efficacy of targeted stereotactic radiosurgery.

"These results in lymphoma are consistent with motexafin gadolinium's

known synergy with radiation, especially with targeted radiation therapy given

over a short time as is the case with Zevalin, and with stereotactic

radiation," said Richard A. Miller, M.D., president and chief executive

officer of Pharmacyclics, and a co-author on the lymphoma study.

Zevalin is a radiolabeled antibody approved for treatment of patients with

relapsed non-Hodgkin's lymphoma. Zevalin binds to tumor cells and emits

radiation to the tumor site. Previously reported studies in the literature

have shown that Zevalin alone produces a 15% complete response rate with

median time to tumor progression of about seven months in rituximab refractory

patients.

About Motexafin Gadolinium (MGd, Xcytrin)

Pharmacyclics is developing MGd as an anti-cancer agent with a novel

mechanism of action that is designed to selectively concentrate in tumors and

induce apoptosis (programmed cell death). Its multifunctional mode of action,

including its magnetic resonance imaging (MRI) detectability, provides the

opportunity for MGd to be used in a broad range of cancers. At the 2007

American Society of Clinical Oncology Annual Meeting (ASCO), Pharmacyclics

announced final results from a Phase 2 clinical trial indicating that MGd may

improve the efficacy of stereotactic radiosurgery by enhancing the activity of

radiation and by providing more accurate MRI treatment planning and better

defining the treatment field in patients with brain metastases from solid

tumors. MGd allowed physicians to identify occult brain metastases in 24% of

patients that were missed with standard MRI contrast agents and were amenable

to stereotactic radiosurgery.

MGd's non-overlapping toxicity makes it an appealing agent to use in

combination with standard chemotherapy regimens. In previously conducted

randomized trials, MGd combined with WBRT has been shown to prolong time to

neurologic progression in patients with brain metastases from non-small cell

lung cancer (NSCLC). Pharmacyclics recently completed patient enrollment in

three Phase 2 trials evaluating MGd in patients with advanced relapsed NSCLC.

These multi-center trials will evaluate MGd as a single agent, in combination

with Taxotere® (docetaxel), and in combination with Alimta® (pemetrexed).

About Pharmacyclics

Pharmacyclics is a pharmaceutical company developing innovative products

to treat cancer and other serious diseases. The company is leveraging its

small-molecule drug development expertise to build a pipeline in oncology and

other diseases based on a wide range of targets, pathways and mechanisms. More

information about the company, its technology, and products can be found at

http://www.pharmacyclics.com. Pharmacyclics® and the "pentadentate" logo®

are registered trademarks of Pharmacyclics, Inc.

Rituxan® is a registered trademark of Biogen Idec Inc. and Genentech,

Inc.

Taxotere® is a registered trademark of Sanofi-Aventis.

Alimta® is a registered trademark of Eli Lilly and Company.

NOTE: Other than statements of historical fact, the statements made in

this press release regarding our expectations and product development plans

are forward-looking statements, as defined in the Private Securities

Litigation Reform Act of 1995. The words "project," "believe," "will," "may,"

"continue," "plan," "expect," "intend," "anticipate," variations of such

words, and similar expressions also identify forward-looking statements, but

their absence does not mean that the statement is not forward-looking. The

forward-looking statements are not guarantees of future performance and are

subject to risks and uncertainties that may cause actual results to differ

materially from those in the forward-looking statements. Factors that could

affect actual results include risks associated with unexpected delays in

clinical trials and preclinical studies and the timing for making related

regulatory filings; the fact that data from preclinical studies and Phase 1 or

Phase 2 clinical trials may not necessarily be indicative of future clinical

trial results; our ability to estimate accurately the amount of cash to be

used to fund operations over the next 12 months, our ability to obtain future

financing and fund the product development of our pipeline; the initiation,

timing, design, enrollment and cost of clinical trials and preclinical

studies; our ability to establish successful partnerships and collaborations

with third parties; the regulatory approval process in the United States and

other countries; and our future capital requirements. For further information

about these risks and other factors that may affect the actual results

achieved by Pharmacyclics, please see the company's reports as filed with the

U.S. Securities and Exchange Commission from time to time, including but not

limited to its annual report on Form 10-K for the period ended June 30, 2007

and its subsequently filed quarterly reports on Form 10-Q. Forward-looking

statements contained in this announcement are made as of this date, and we

undertake no obligation to publicly update any forward-looking statement,

whether as a result of new information, future events or otherwise.

SOURCE Pharmacyclics, Inc.

Copyright © 2008 PR Newswire. All rights reserved.

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