SUNNYVALE, Calif., May 25 /PRNewswire-FirstCall/ -- Pharmacyclics, Inc. announced today multiple presentations and published abstracts regarding Xcytrin(R) (motexafin gadolinium) Injection, including an oral presentation of Phase 3 SMART (Study of Neurologic Progression with Motexafin Gadolinium And Radiation Therapy) trial data. The presentations and publications are part of the proceedings at the 2006 American Society of Clinical Oncology Annual Meeting (ASCO) being held June 2-6, 2006, at the Georgia World Congress Center in Atlanta, GA. The company will have booth # 4855 in the Exhibit Hall.
The company also announced that it will hold an investor reception featuring executive management and SMART trial investigators on Saturday, June 3rd, following the lung cancer session, where additional data and new analyses from the Phase 3 SMART trial will be presented. The company also will host a conference call on Monday, June 5th at 9:00 a.m. EDT to discuss the ASCO presentation.
The presentations and published abstracts are as follows: Saturday, June 3, 2006 Session: Lung Cancer
Oral Presentation: Motexafin gadolinium (MGd) combined with prompt whole brain radiation therapy (RT) prolongs time to neurologic progression in non- small cell lung cancer (NSCLC) patients with brain metastases: Results of a Phase 3 trial
Abstract # 7014: 5:30-5:45 p.m.
Location: Bldg C, Level 1, Hall C2
Presenter: Minesh P. Mehta, M.D., University of Wisconsin; followed by 15 minute discussion by Laurie Gaspar, M.D., University of Colorado
Sunday, June 4, 2006
Session: Pediatric Cancer II
Oral Presentation: Phase I Study of Motexafin-Gadolinium (MGd) with Radiation Therapy (RT) for Children with Newly-Diagnosed Brain Stem Gliomas (BSG): A Children's Oncology Group Study
Abstract # 9014: 10:15 - 10:30 a.m. Location: Bldg B, Level 2, Room B211 Presenter: Kristin Bradley, M.D., University of Wisconsin Monday, June 5, 2006 Session: Central Nervous System Tumors
Oral Presentation: Improvement in neurocognitive function (NCF) correlates with tumor regression after whole brain radiation therapy (WBRT) for brain metastases (BM)
Abstract # 1504: 4:15 - 4:30 p.m. Location: Bldg C, Level 3, Georgia Ballroom 3 Presenter: Jing Li, M.D., Ph.D., University of Wisconsin Motexafin Gadolinium Published Abstracts Abstract # 14518
Title: Phase II Trial of Motexafin Gadolinium (MGd) for Treatment of Metastatic Renal Cell Carcinoma (MRCC)
Abstract # 13115
Title: A phase I trial combining motexafin gadolinium (MGd) with docetaxel in the treatment of advanced solid tumors
Conference Call Details
Pharmacyclics will hold a conference call on Monday, June 5, 2006 at 9:00 a.m. EDT to discuss the ASCO presentation. To participate in the conference call, please dial 888-499-6736 for domestic callers and 706-679-5597 for international callers, and reference conference passcode 9100260. In addition, this call is being webcast and can be accessed at Pharmacyclics' website at www.pharmacyclics.com by clicking on the investor section and following the links from there. Please connect to Pharmacyclics' website several minutes prior to the start of the live webcast to ensure adequate time for any software download that may be necessary. A telephone replay of the conference call will be available through Monday, June 12, 2006. To access the replay, please dial 800-642-1687 for domestic callers and 706-645-9291 for international callers and reference conference passcode 9100260.
About Xcytrin
Pharmacyclics is developing Xcytrin 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). Xcytrin is a redox-active drug that has been shown to disrupt redox-dependent pathways in cells and inhibit oxidative stress related proteins. Its multifunctional mode of action provides the opportunity to be used in a broad range of cancers.
About Pharmacyclics
Pharmacyclics is a pharmaceutical company developing innovative products to treat cancer, atherosclerosis 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. Its lead product, Xcytrin, has completed Phase 3 clinical testing in lung cancer brain metastases and several Phase 1 and Phase 2 clinical trials are ongoing with Xcytrin, either as a single agent or in combination with chemotherapy and/or radiation in multiple cancer types. Pharmacyclics has other product candidates in earlier-stage development for cancer, atherosclerosis and inflammatory diseases. More information about the company, its technology, and products can be found at www.pharmacyclics.com. Pharmacyclics(R), Xcytrin(R) and the "pentadentate" logo(R) are registered trademarks of Pharmacyclics, Inc.
NOTE: Other than statements of historical fact, the statements made in this press release about enrollment and future plans for our clinical trials, progress of and reports of results from preclinical and clinical studies, including results from our SMART trial, clinical development plans and product development activities are forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995. The words "potential," "project," "believe," "will," "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 the initiation, timing, design, enrollment and cost of clinical trials; unexpected delays in and unanticipated increases in costs related to our preclinical studies and clinical trials; 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 obtain future financing and fund the product development of our pipeline; the outcome of our discussions with the FDA; our ability to prepare and submit an NDA on a timely basis or at all; the possibility that the FDA refuses to accept any NDA we submit; the possibility that additional data or studies may be required before the NDA is accepted for filing or approved by the FDA; our ability to establish successful partnerships and collaborations with third parties; the regulatory approval process in the United States and other countries; and 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 quarterly report on Form 10-Q for the period ended December 31, 2005. 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.
Pharmacyclics, Inc.CONTACT: Leiv Lea of Pharmacyclics, Inc., +1-408-774-0330; or CarolynBumgardner Wang of WeissComm Partners, +1-415-946-1065, for Pharmacyclics,Inc.
Web site: http://www.pharmacyclics.com//
