- Kosan Biosciences has announced that the FDA has granted the company’s anticancer compound 17-allylamino-17-demethoxy-geldanamycin (17-AAG), an analog of the polyketide geldanamycin, orphan drug status for the treatment of multiple myeloma.
- Schering-Plough is initiating two large international clinical trials to evaluate the use of peginterferon alfa-2b (PegIntron) and ribavirin (Rebetol) combination therapy in patients chronically infected with hepatitis C virus genotype 1 who have specific unmet medical needs.
- Vion Pharmaceuticals has been granted orphan drug designation from the FDA for VNP40101M (Cloretazine) for the treatment of acute myelogenous leukemia.
- Kosan Biosciences has announced that the FDA has granted its anticancer compound 17-allylamino-17-demethoxy-geldanamycin, or 17-AAG, orphan drug status for the treatment of chronic myelogenous leukemia.
- Bayer Pharmaceuticals Corp. and Onyx Pharmaceuticals have announced that sorafenib (BAY 43-9006) has been granted orphan drug status by the FDA for the treatment of renal cell carcinoma.
- Peninsula Pharmaceuticals has announced that the FDA has granted fast-track designation for doripenem (S-4661) for the treatment of nosocomial pneumonia, including ventilator-associated pneumonia.
- Neurocrine Biosciences has initiated a Phase I clinical trial with its proprietary compound, urocortin 2, to evaluate the safety, pharmacokinetics, and pharmacodynamics of urocortin 2 in healthy volunteers and also expects to initiate a Phase II clinical study in patients with mild-to-moderate congestive heart failure in early 2005.
- Hybridon has begun patient enrollment of a Phase II trial of HYB2055 (IMOxine) in renal cell carcinoma.
- Alexion Pharmaceuticals has initiated the treatment phase in the Phase III TRIUMPH trial, evaluating the investigational drug eculizu-mab in patients with paroxysmal nocturnal hemoglobinuria.
- Vertex Pharmaceuticals has initiated a Phase Ib clinical trial for VX-950, an investigational oral protease inhibitor for the treatment of hepatitis C virus infection.
- Pharmasset has initiated a Phase II clinical study to assess the safety, tolerability, and antiviral effect of substituting Racivir (RCV) for lamivudine, 3TC (Epivir) in treatment-experienced HIV-infected individuals.
- CuraGen Corp. has announced that the FDA has granted orphan drug designation to CR002, a fully human monoclonal antibody, as a potential treatment to slow the progression of IgA nephropathy and delayed kidney failure in patients affected by the disease.
- Vasogen has reached full enrollment in its 500-patient Phase III SIMPADICO trial of immune modulation therapy (Celacade) for the treatment of peripheral arterial disease.
- Lorus Therapeutics has initiated a clinical trial of its antisense drug, GTI-2040, in combination with docetaxel and prednisone in hormone refractory prostate cancer.
- YM BioSciences and its majority-owned subsidiary CIMYM have announced that the Office of Orphan Products Development of the FDA has granted orphan drug designation to their EGF receptor monoclonal antibody, TheraCIM hR3, for the treatment of glioma.
- Human Genome Sciences has begun dosing patients in a Phase II clinical trial of albumin-interferon alpha (Albuferon) in combination with ribavirin to evaluate the safety, tolerability, and efficacy of albumin-interferon alpha in patients with chronic hepatitis C who failed to respond to previous interferon alpha-based treatment regimens.
- BioMarin Pharmaceutical expects to initiate a six-week, multicenter, international, double-blind, placebo-controlled Phase III clinical trial of sapropterin hydrochloride (Phenoptin) in phenylketonuria in the first quarter of 2005.
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