- Millennium Pharmaceuticals has initiated EVEREST (Evaluation of Velcade [bortezomib] Employed as Retreatment for Efficacy, Safety, and Tolerability). This is a multicenter Phase IV clinical trial of bortezomib in multiple myeloma patients who have previously responded to bortezomib and relapsed following a treatment-free remission.
- Pharmacyclics has completed patient enrollment in its pivotal Phase III clinical trial of motexafin gadolinium (Xcytrin) injection for the potential treatment of lung cancer patients with brain metastases.
- Genta has announced that LR3001, an antisense compound directed against a gene known as c-myb, has received orphan drug designation from the FDA for the treatment of chronic myelocytic leukemia.
- AnorMED has initiated enrollment in a Phase Ib/IIa trial to evaluate the potential of AMD070, an oral CXCR4 HIV entry inhibitor, in HIV-infected patients.
- The Gynecologic Oncology Group has initiated a Phase III clinical trial examining the ability of paclitaxel poliglumex (Xyotax) to maintain remission and prolong the survival of ovarian cancer patients.
- Cara Therapeutics has initiated dosing in a Phase I clinical trial for CR665, its novel drug candidate for the treatment of postoperative pain.
- MediciNova has enrolled patients in a Phase II clinical study with MN-001, a novel, orally administered asthma drug that was licensed from Kyorin Pharmaceutical Co.
- Vion Pharmaceuticals has commenced dosing the first patient on the Phase III pivotal trial of its anticancer agent VNP40101M (Cloretazine) in relapsed acute myelogenous leukemia.
- Human Genome Sciences has begun dosing patients in a Phase I clinical trial to evaluate the safety, tolerability, and pharmacology of CCR5 mAb in patients who are infected with HIV-1.
- ID Biomedical Corp. has completed the enrollment of 1,000 subjects for its Fluviral clinical trial intended to support accelerated approval in the United States.
- Theravance has announced that the FDA has granted fast-track designation to telavancin for the treatment of hospital-acquired pneumonia and complicated skin and skin structure infections.
- American Pharmaceutical Partners has announced that American BioScience has initiated enrollment in a Phase II study of ABI-007 (Abraxane) administered weekly in combination with trastuzumab (Herceptin) in first-line treatment of metastatic breast cancer.
- PharmaMar announced today that its marine-derived anti-cancer drug, trabectedin (Yondelis), has been granted orphan drug designation by the FDA for the treatment of ovarian cancer.
- Valentis has initiated patient dosing in a Phase IIb clinical trial to evaluate the safety and efficacy of VLTS-934, a poloxamer, in patients with peripheral arterial disease, specifically intermittent claudication.
- Kosan Biosciences has announced that its Phase II clinical trial of KOS-862 (Epothilone D) as monotherapy for patients with metastatic breast cancer will proceed to full enrollment of the study following the successful completion of the interim analysis.
- BioMarin Pharmaceutical has randomized the first patient in its Phase III clinical trial of sapropterin hydrochloride (Phenoptin), an investigational oral, small molecule therapeutic for the treatment of the genetic disease phenylketonuria.
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