Amicus Files IND Application for Compound to Treat Gaucher Disease
Amicus Therapeutics, Cranbury, N.J., has submitted an Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA) for its compound AT2101 to treat Gaucher disease, and plans to begin phase I clinical trials in June.
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Astex Receives IND Approval for Novel Cancer Drug
Astex Therapeutics, Cambridge, UK, announced that the FDA approved its IND application for the clinical development of its proprietary Aurora Kinase inhibitor, AT9283, to treat cancer.
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Entremed Begins Clinical Trial for Breast Cancer
EntreMed Inc., Rockville, Md., initiated a phase Ib study to test its lead clinical-stage drug candidate, Panzem NCD, in combination with paclitaxel (Taxol) in patients with metastatic breast cancer at the Duke University Medical Center, Durham, N.C.
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Clinical Study to Use Stem Cells from Fat for Breast Reconstruction
Cytori Therapeutics Inc., San Diego, received approval from the Institutional Review Board to begin an investigator-initiated safety and feasibility study in Japan using adult adipose-derived stem and regenerative cells for breast reconstruction.
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FDA Accepts NDA from Novartis for New Hypertension Treatment
Novartis Pharmaceuticals Corp., East Hanover, N.J., says that the FDA has accepted its New Drug Application (NDA) for review for Rasilez (aliskiren), a renin inhibitor that represents the first new treatment approach for people with high blood pressure in more than a decade.
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Sirna Granted First Broad siRNA Patent for a Gene Target in US
Sirna Therapeutics Inc., San Francisco, was issued a US patent that covers any chemically modified siRNA targeting I Kappa B kinase-gamma and sets an important precedent for Sirna's entire target patent portfolio.
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MedImmune Begins Trial to Treat Lupus
MedImmune Inc., Gaithersburg, Md., began dosing patients in a phase I clinical trial to evaluate safety and tolerability of MEDI-545, its monoclonal antibody targeting interferon-alpha to treat patients with systemic lupus erythematosus.
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FDA Grants Fast Track Designation for Thrombin Receptor Antagonist
Schering-Plough, Kenilworth, N.J., reported that the FDA granted a Fast Track designation to its investigational oral thrombin receptor antagonist, SCH 530348, currently in phase II clinical development to prevent cardiovascular morbidity and mortality outcomes in at-risk patients.
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PTC Compound Fast Tracked for Duchenne Muscular Dystrophy
PTC Therapeutics Inc., South Plainfield, N.J., announced that the FDA granted a Fast Track designation for the development of PTC124 to treat Duchenne muscular dystrophy.
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PowderMed Hepatitis B Vaccine Begins Clinical Trials
PowderMed, Oxford, UK, announced that its dual-antigen encoding immunotherapeutic vaccine for Hepatitis B has received FDA IND approval along with approvals from the Singapore, Hong Kong, and Taiwanese Regulatory Authorities and has entered phase I clinical trials.
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