NoBlood

Jan B. Wade · #1 (**permalink**) 03-16-2007, 01:35 PM

Associated Press
Neose Cleared for Anemia Drug Trials

Biopharmaceutical company Neose Technologies Inc. said Thursday the Food and Drug Administration cleared plans for clinical trials on the company's anemia treatment candidate. The drug candidate, NE-180, aims to treat anemia in adult cancer patients receiving chemotherapy and in patients with chronic kidney disease. The drug is already in mid-phase clinical trials for cancer-related anemia in Switzerland.
Neose Receives Approval to Commence Phase II Clinical Trial For NE-180
HORSHAM, Pa., Jan 16, 2007 (BUSINESS WIRE) -- Neose Technologies, Inc. (Nasdaq:NTEC) today announced that it has received approval from Swissmedic, the Swiss Agency for Therapeutic Products, for the initiation of a Phase II human trial for NE-180. Clinical trial supplies have been shipped, and patient recruitment has commenced. 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.

The Phase II 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 45 cancer patients receiving platinum-based chemotherapy. Fixed doses of NE-180 will be administered every three weeks with each cycle of chemotherapy for an expected duration of four chemotherapy cycles.

"This approval marks another important step forward in our NE-180 clinical development program," said George J. Vergis, Ph.D., Neose president and chief executive officer. "The once-per-chemotherapy cycle dosing included in the study protocol is reflective of our preclinical findings and Phase I results for NE-180. In addition to the current Phase II trial, we plan to initiate our Phase II renal program in 2007."

Neose Technologies Presents Positive NE-180 Phase I Clinical Trial Data at American Society of Hematology Annual Meeting
HORSHAM, Pa.--(BUSINESS WIRE)--Dec. 11, 2006--Neose Technologies, Inc. (Nasdaq GM:NTEC) presented positive data from its NE-180 Phase I clinical trial during the American Society of Hematology 48th Annual Meeting and Exposition. The data were presented in a poster entitled, "NE-180, a Novel GlycoPEGylated(TM) Erythropoietin, Demonstrates Dose-Dependent Activity in a Phase 1, Single Dose, Dose Escalation Study in Normal Human Volunteers" on December 9, 2006. NE-180 is being developed for the treatment of anemia associated with chronic kidney disease, including patients on dialysis and patients not on dialysis, and for the treatment of anemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.

Conclusions from the study are as follows:
-- Single doses of NE-180, up to 1.5mcg/kg, were generally
well-tolerated with no serious adverse events.
-- Single doses of NE-180 demonstrated potent, dose-dependent
erythropoietic activity.
-- The results from the Phase I study support a Phase II program
in patients with anemia associated with chronic kidney
disease, dosed every four weeks, and in cancer patients
receiving chemotherapy, dosed every three weeks.

The full poster presentation can be found on the Neose website via the following link: http://phx.corporate-ir.net/phoenix.zhtml?c=60494&p=irol-presentations

"We are excited by the data generated in this Phase I trial, particularly the increases in reticulocytes and hemoglobin. These increases support further clinical development of our GlycoPEGylated erythropoietin candidate. We look forward to commencing our Phase II clinical trials in the near future," said George J. Vergis, Ph.D., Neose president and chief executive officer.
http://library.corporate-ir.net/library/60/604/60494/items/166871/NEO0006.pdf