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Neose Announces Initiation of Phase II Renal Trial of NE-180 |
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11 Sep 2007 |
Neose Technologies, Inc. today announced that dosing has commenced in its Phase II clinical trial of NE-180 in renal patients
HORSHAM, PA, USA | September 10, 2007 | Neose Technologies, Inc. (NasdaqGM:NTEC) today announced that dosing has commenced in its Phase II clinical trial of NE-180 in renal patients. NE-180 is a long-acting, GlycoPEGylated erythropoietin (EPO) being developed for the treatment of anemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy and for the treatment of anemia associated with chronic kidney disease, including patients on dialysis and patients not on dialysis. A Phase II trial in patients with chemotherapy-induced anemia was commenced earlier in 2007.
The Phase II renal trial is designed as an open label, sequential, ascending dose study to evaluate the safety, tolerability and dose response of NE-180 administered subcutaneously. The trial is expected to enroll up to 60 patients with anemia associated with chronic renal failure. Fixed doses of NE-180 will be administered every four weeks.
"The expansion of the clinical development program for NE-180 into renal patients before the end of 2007 was a key corporate objective. We now have two ongoing Phase II trials to demonstrate a safe, effective, long-acting profile for this compound in both of the key segments of the erythropoietin category," said George J. Vergis, Ph.D., Neose president and chief executive officer.
About Neose Technologies, Inc.
Neose Technologies, Inc. is a clinical-stage biopharmaceutical company focused on the development of next-generation therapeutic proteins that are competitive with best-in-class protein drugs currently on the market, on its own and through strategic partnerships. The lead candidates in its pipeline, NE-180 for use in the treatment of chemotherapy-induced anemia and anemia associated with chronic renal failure and GlycoPEG-GCSF for chemotherapy-induced neutropenia, target markets with 2006 aggregate sales in excess of $15 billion. For more information, please visit www.neose.com.
Neose "Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release regarding our business that are not historical facts are "forward-looking statements" that involve risks and uncertainties, including without limitation the risk that NE-180 fails in clinical trials, the risk that we will never receive regulatory approval of NE-180 and the risk that we will be unable to successfully commercialize or market NE-180. For a discussion of these risks and uncertainties, any of which could cause our actual results to differ from those contained in the forward-looking statement, see the section of Neose's Annual Report on Form 10-K for the year ended December 31, 2006, entitled "Factors Affecting the Company's Prospects" and discussions of potential risks and uncertainties in Neose's subsequent filings with the SEC.
SOURCE: Neose Technologies, Inc. |
