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Biotech / Medical : NEXL -- Ignore unavailable to you. Want to Upgrade?

To: Czecho who wrote (1293)	3/17/1998 8:37:00 AM
From: GREATMOOD	Read Replies (1) \| Respond to of 1704

Nexell Therapeutics Filed Supplemental Application With the FDA On Isolex300i Stem Cell Selection System WILMINGTON, DE--(BW HealthWire)--March 17, 1998--Nexell Therapeutics Inc., a subsidiary of VIMRX Pharmaceuticals Inc. (NASDAQ:VMRX), announced today that it has filed a supplement to its pre-market approval (PMA) application for the Isolex(R)300 Stem Cell Selection System requesting review of the Isolex(R)300i Stem Cell Selection System. The Isolex(R)300i is the fully automated version of the Isolex(R)300 cell selection device for the clinical separation of CD34+ stem cells from peripheral blood, adding increased processing ease and efficiency. "The submission to the FDA of the Isolex(R)300i system is an important regulatory milestone for Nexell because we are requesting a simultaneous review of both cell selection devices for market approval in the U.S.," said L. William McIntosh, Nexell president and CEO. "The two generations of Isolex(R) Stem Cell Selection Systems would offer transplant clinicians the option to use the flexible Isolex(R)300 for semi-automated stem cell selection procedures, or the fully automated Isolex(R)300i with increased speed, convenience and consistency for large numbers of cell selection procedures." Both the Isolex(R)300 and Isolex(R)300i Stem Cell Selection Systems have CE mark approval in Europe and are currently marketed in Europe and a number of other countries outside of the U.S. A decision by the U.S. FDA is anticipated mid-year 1998. To support the supplement, Nexell submitted data collected from three separate clinical studies, including a randomized, controlled clinical trial treating 114 patients (92 randomized) with high risk or advanced breast cancer, and two supporting single-arm uncontrolled studies treating 82 patients with B-cell malignancies. The studies provide data supporting the safety and effectiveness of the Isolex(R)300i Cell Selection System for enrichment of CD34+ cells from autologous peripheral blood stem cells. In the controlled safety trial of breast cancer patients following high dose chemotherapy, patients receiving the Isolex(R)300i-selected autologous CD34+ cells clearly demonstrated no delay in time to neutrophil (infection fighting white blood cells) or platelet recovery when compared to the patients who received unselected cells. Further, there was no difference in days of hospitalization, days of antibiotic therapy, transfusion support or incidence of infections between the two groups, further supporting the reconstituting capability of the Isolex(R)-selected cells. The Isolex(R) procedure reduced the non-target (non-CD34+) cells in the infusion product by approximately 3 logs, which could provide benefit to the patient by reducing the number of non-target cells, including tumor cells, being reinfused. Based on the supplement and the original submission, Nexell is requesting clearance to market both cell selection devices to support the enrichment of CD34+ cells and the reduction of non- target (non-CD34+) cells, including tumor cells, in autologous transplants involving patients with breast cancer, NHL, and other B-cell malignancies using either cell selection device for processing peripheral blood stem cell products for support after high dose chemotherapy. "We are pleased to have submitted clinical data to the FDA demonstrating that the two Isolex(R) Stem Cell Selection devices provide consistent and equivalent final cell products and, therefore, could be reviewed simultaneously," continued McIntosh. "Nexell believes it has submitted data supporting the clinical issues important to the FDA with regard to the reduction of non-target cells, including tumor cells, which is the primary clinical utility intended to improve disease free survival of patients." Nexell Therapeutics Inc. Located in Irvine, California, Nexell Therapeutics Inc. is a biotechnology company jointly owned by VIMRX Pharmaceuticals Inc. (NASDAQ:VMRX) and Baxter Healthcare Corporation, the principal domestic operating subsidiary of Baxter International Inc. (NYSE:BAX), that is developing and marketing innovative cell therapies for cancer and other life threatening diseases. The company's lead product, the Isolex(R)300 Stem Cell Selection System is marketed in Europe and other numerous countries and is currently under regulatory review in the United States. The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for certain forward-looking statements. The forward-looking statements contained in this release are subject to certain risks and uncertainties. Actual results could differ materially from current expectations. Among the factors which could affect the Company's actual results and could cause results to differ from those contained in the forward-looking statements contained herein are the success of the Company's clinical trials, delays in receiving FDA or other regulatory approvals and the development of competing therapies and/or technologies by other companies. # # # -0- NOTE TO INVESTORS AND EDITORS: Nexell's press releases are available on the Internet through www.vimrx.com and through BusinessWire's web site at businesswire.com. The releases also are available at no charge through BusinessWire's fax-on-demand service at 800-411-8792. --30--rg/ny* CONTACT: Media Contact: Laura A. Mastrangelo VIMRX Pharmaceuticals 302-998-1734/Pager 800-916-8038 or Contact: Dian Griesel, Ph.D. The Investor Relations Group 212-664-8489