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Xanthus Pharmaceuticals announced that the FDA has granted orphan drug designation to Xanafide (amonafide malate) for the treatment of acute myeloid leukemia (AML).
Osiris Therapeutics announced that Prochymal has received FDA fast-track designation, which will expedite the development of the stem-cell treatment for Crohn's disease that does not respond to standard therapies.
ImClone Systems and Bristol-Myers Squibb (BMS) have announced that a Phase III study of Erbitux (cetuximab) plus Folfiri (an irinotecan-based chemotherapy) met the primary endpoint of increasing median duration of progression-free survival over Folfiri alone in patients with previously untreated metastatic colorectal cancer.
Medivir has filed an application with European regulatory authorities to begin Phase I clinical trials with MIV-701, an inhibitor of cathepsin K. The trials are expected to start during the first quarter.
Provectus Pharmaceuticals' leading anti-cancer agent, PV-10, has been granted orphan drug designation by the FDA for the treatment of metastatic melanoma.
Nuvelo has begun enrolling patients in a Phase II trial of recombinant nematode anticoagulant protein c2 (rNAPc2) for the treatment of metastatic colorectal carcinoma, the second leading cause of cancer-related death in the United States, according to the company.
Hypnion has announced that its Phase II clinical trial evaluating HY10275 at doses of 1 and 3 mg in adults with transient insomnia met primary and secondary endpoints.