- Viventia Biotech has announced that the FDA has designated the company’s lead drug, Proxinium (formerly known as VB4-845), as a fast-track product for the treatment of patients with recurrent squamous cell carcinoma of the head and neck.
- Dendreon Corp. has announced that the FDA has granted fast track review status to sipuleucel-T (Provenge) for its proposed use in the treatment of asymptomatic men with metastatic, androgen-independent prostate cancer.
- NeoRx Corp. has received orphan drug designation from the FDA for the company’s investigational product picoplatin, a next-generation platinum therapy, for the treatment of small cell lung cancer.
- Myogen has achieved target enrollment of 186 patients in ARIES-1, one of the company’s two pivotal Phase III trials of ambrisentan in patients with pulmonary arterial hypertension.
- Migenix has initiated enrollment in a Phase IIb combination therapy clinical trial of celgosivir (MX-3253), supported in part through an agreement with Schering-Plough. Celgosivir is an orally administered, first-in-class alpha glucosidase 1 inhibitor, in development for the treatment of chronic hepatitis C virus infections.
- Vertex Pharmaceuticals has announced that the FDA has granted fast-track designation to VX-950, an investigational oral hepatitis C virus (HCV) protease inhibitor for the treatment of HCV infection.
- Spectrum Pharmaceuticals has announced the opening of accrual of a Phase II study evaluating the company’s lead drug candidate, satraplatin, in combination with paclitaxel (Taxol) as a first-line therapy in patients with unresectable advanced non-small cell lung cancer.
- Kosan Biosciences has initiated a Phase II clinical trial in patients with HER2-positive metastatic breast cancer, administering KOS-953 in combination with trastuzumab (Herceptin).
- Exelixis has initiated a multitrial Phase II clinical development program for XL999. The Phase II program is composed of six trials that will evaluate XL999 in a variety of cancer indications.
- Penwest Pharmaceuticals Co. has completed patient enrollment for its Phase IIa trial of PW4142, an extended-release tablet that the company is developing for the treatment of pain. PW4142 is an oral formulation of a compound that currently is available only as an injection.
- BioCryst Pharmaceuticals has initiated a Phase I/II clinical trial of Fodosine(TM) (forodesine hydrochloride), the company’s lead anticancer compound, to determine the safety of repeat doses of an intravenous (IV) formulation of the drug in patients with B-cell acute lymphoblastic leukemia.
- Keryx Biopharmaceuticals announced today the initiation of a corporate-sponsored clinical program to evaluate KRX-0401 (perifosine) as a treatment for multiple myeloma.
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