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Biotech / Medical : NexStar Pharm(NXTR) -- Ignore unavailable to you. Want to Upgrade?

To: Miljenko Zuanic who wrote (314)	2/3/1999 9:54:00 PM
From: Miljenko Zuanic	Read Replies (1) \| Respond to of 328

If the speed of the clinical trials for NX211 is like for MiKasome, well, it may be ready for NDA in new millenniuuuummmmmm ( I mean 3000)! Miljenko NeXstar Pharmaceuticals Initiates the First in a Series of Planned Phase I Clinical Trials for NX 211 BOULDER, Colo., Feb. 3 /PRNewswire/ -- NeXstar Pharmaceuticals Inc. (Nasdaq: NXTR - news) has initiated the first in a series of planned Phase I clinical trials for its newest drug candidate NX 211, a liposomal form of the investigational anticancer drug lurtotecan, a proprietary topoisomerase I inhibitor. The goal of this study is to test the safety of the product in patients with advanced-stage solid tumors. The first clinical trials for NX 211 are being conducted in The Netherlands, specifically in the cities of Rotterdam and Groningen. Additional Phase I studies are planned for Canada and the United States. In Canada, the company's Investigational New Drug application (IND) has been submitted and enrollment is expected to begin this Spring. The IND application to the U.S. Food and Drug Administration (FDA) is expected to be submitted during the first half of 1999, and enrollment for this trial is planned for the second half of 1999. ''We are pleased to initiate our clinical program for NX 211 and to collaborate with leading oncologists worldwide,'' said Nicole Onetto, M.D., vice president of medical affairs for NeXstar Pharmaceuticals. ''Our Phase I program will allow us to characterize the safety profile of this drug, and efficiently select the optimal schedule for the Phase II clinical program.'' Subsequent clinical trials are planned to evaluate NX 211 against refractory ovarian cancer and refractory small cell lung cancer in the Phase II program. Additional studies will evaluate the drug in a variety of solid tumors and hematologic malignancies. NeXstar Pharmaceuticals acquired lurtotecan under exclusive license from Glaxo Wellcome in May 1998. As a part of this collaboration, NeXstar scientists produced a liposomal formulation of lurtotecan, called NX 211. Preclinical study results showed that NX 211 had a three-fold increase in therapeutic index (the ratio between an effective dose and a toxic dose) as compared to the conventional drug. These studies showed that the plasma half life (a measure of circulation time) and the area under the curve (a measure of drug exposure) of NX 211 are significantly increased as compared to the conventional drug. As a result, the potential exists for NX 211 to be more effective and less toxic than lurtotecan and other topoisomerase inhibitors. ''Our research indicates that there is a significant need for topoisomerase I agents with better efficacy, safety and dosing profiles,'' said Michael Hart, chairman of the management committee and CFO of NeXstar Pharmaceuticals. ''The overall market for topoisomerase I agents is estimated to be $253 million. This market size is expected to grow considerably over the next year, and we believe NX 211 may offer an attractive treatment alternative within this market.'' NeXstar Pharmaceuticals Inc. recently announced it will proceed to separate its existing businesses, creating two independent, publicly-traded companies. One company, continuing under the NeXstar Pharmaceuticals Inc., will become a specialty pharmaceutical company. This company will focus on oncology and infectious diseases, leveraging its core liposomal technology, its unique sales and marketing infrastructure and its drug development expertise for in-licensing late stage compounds. The other company, to be named Iterex Technologies Inc., will further commercialize its proprietary compound discovery technologies. Iterex will focus on collaborations, partnerships and licensing agreements with pharmaceutical, biotechnology, diagnostics, agrochemical and animal health companies. This press release contains forward-looking statements that involve risks and uncertainties, and actual events or results may differ materially. While these statements reflect NeXstar Pharmaceuticals' best current judgment, they are subject to risks and uncertainties that could cause actual results to vary from current projections. These risk factors are identified in NeXstar Pharmaceuticals' reports to the Securities and Exchange Commission filed on Forms 10-K and 10-Q, and in other SEC filings. This release can be obtained from our website at nexstar.com SOURCE: NeXstar Pharmaceuticals Inc.