Non-U.S. Clinical Trials And Regulatory Actions: May 2007
Company* (Country; Symbol) | Product | Description | Indication | Status (Date) |
CANCER | ||||
Amgen Inc. (AMGN) | Vectibix (FDA-approved) | Panitumumab; fully human monoclonal antibody directed against the epidermal growth factor receptor | Colorectal cancer | Amgen is appealing the negative opinion on the marketing clearance of Vectibix from the CMPH (5/25) |
Ark Therapeutics Group plc (UK; PK:ARKTF) | Cerepro | Gene therapy | Glioma | EMEA said it would not give approval without further analysis of Phase II data, or new data from a Phase III trial (5/2)** |
Can-Fite BioPharma* (Israel) | CF101 | Agent that targets the A3 adenosine receptor | Psoriasis | Received Ministry of Health and EC approval to begin Phase II trials (5/16) |
Genentech Inc. (NYSE:DNA) and F. Hoffmann-La Roche Ltd. (Switzerland) | Herceptin (FDA-approved) | Trastuzumab | Metastatic breast cancer | European Commission approved its use in combination with an aromatase inhibitor in patients with HER2 and horomone receptor co-positive metastatic breast cancer (5/3) |
HUYA Bioscience International LLC* and Chipscreen Biosciences Ltd.* (China) | Chidamide/HBI-800 | An orally bioavailable histone deacetylase inhibitor derived from the benzamide class | Cancer | Phase I trial was initiated in China (5/23) |
Indevus Pharmaceuticals Inc. (IDEV) | Vantas | Histrelin acetate subcutaneous implant | Prostate cancer | European regulators expanded approval to five new countries, the UK, Ireland, Germany, Spain and Italy; it was approved in Denmark in 2005 (5/31) |
Oncoloytics Biotech Inc. (Canada; ONCY; TSX:ONC) | Reolysin | Intravenous formulation of the human reovirus that targets the activated Ras pathway | Advanced cancers | Started enrolling patients in a UK trial of Reolysin in combination with paclitaxel and carboplatin (5/29) |
CARDIOVASCULAR | ||||
Cardiome Pharma Corp. (Canada; CRME; TSX:COM) and Astellas Pharma Canada Inc. | Vernakalant hydrochloride | Intravenous formulation | For acute conversion of atrial fibrillation | Filed a new drug submission with Health Canada (5/30) |
Encysive Pharmaceuticals Inc. (ENCY) | Thelin | Sitaxsentan sodium; 100-mg tablets | Pulmonary arterial hypertension | Canadian authorities approved Thelin (5/31) |
Pharmaxis Ltd. (Australia; PXSL) | Aridol | Mannitol formulation delivered via an inhalation device | Chronic obstructive pulmonary disease | First patients have been enrolled in a Swiss trial evaluating Aridol's ability to predict the response to inhaled steroids (5/15) |
CENTRAL NERVOUS SYSTEM | ||||
BioLineRx Ltd.* (Israel) | BL-1020 | GABA enhanced anti-psychotic candidate | Schizophrenia | Began a randomized, open-label study in Sweden (5/16) |
DIABETES | ||||
Oramed Pharmaceuticals Inc. (Israel; OTC BB:ORMP) | Oral Insulin | Orally ingestible soft gel capsule | Diabetes | Began a Phase I trial in Israel (5/8) |
INFECTION | ||||
Astellas Pharma Inc. (Japan; PK:ALPMF) and Theravance Inc. (THRX) | Telavancin | An injectable antibiotic; lipoglycopeptide | Complicated skin and soft tissue infections | Submitted an MAA to the EMEA (5/1) |
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Avir Green Hills Biotechnology* (Austria) | FluVacc | Influenza vaccine based on the deletion of the NS1 gene | Influenza | Started the first Phase I study in Vienna (5/16) |
Crucell NV (the Netherlands; CRXL) | AERAS-402 | AdVac-based tuberculosis vaccine developed using PER.C6 manufacturing technology | Tuberculosis | Crucell, the Aeras Global TB Vaccine Foundation and the South African Tuberculosis Vaccine Initiative launched a Phase I trial in South Africa (5/11) |
Omrix Biopharmaceuticals Inc. (OMRI) | HBIG | Hepatitis B immunoglobulin | Hepatitis B virus | Filed for approval in Sweden (5/7) |
Sinovac Biotech Ltd. (China; AMEX:SVA) | Panflu | A vaccine against the H5N1 strain of pandemic influenza virus | Influenza | Was granted approval in China to start Phase II trials (5/9) |
Theravance Inc. (THRX) | Telavancin | ipoglycopeptide; bactericidal injectable antibiotic | Complicated skin and soft tissue infections | European regulators accepted an application for the marketing of telavancin (5/31) |
| MISCELLANEOUS | ||||
Angiotech Pharmaceuticals Inc. (Canada; TSX:ANP; ANPI) | Vascular Wrap | Paclitaxel-eluting mesh | End-stage renal disease | Began a study in Europe to evaluate the safety and efficacy of the wrap after surgical implantation with an ePTFE vascular graft in the upper extremity for hemodialysis vascular access (5/30) |
Ardana plc (UK; LSE:ARA) | ARD-07 | An oral growth hormone secretagogue | Growth hormone deficiency | Was granted orphan drug status (5/23)** |
Clinuvel Pharmaceuticals Ltd. (Australia; ASX:CUV) | CUV1647 | Agent designed to stimulate production of eumelanin | Polymorphic light eruption | Began a Phase III trial in Europe (5/21) |
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Debiopharm Group* (Switzerland) | Salvacyl/Moapar | Sustained-release formulation; gonadotropin-releasing hormone agonist analogue | Sexual deviations | Completed European mutual recognition procedure in Germany, Belgium, Denmark, Finland, France, Norway, the Netherlands and the UK; it was approved last year in Sweden (5/24) |
Progenics Pharmaceuticals Inc. (PGNX) | MNTX | Methylnaltrexone; peripherally acting opioid-receptor antagonist | Opioid-induced constipation | Filed for European approval (5/14) |
Scil Technology GmbH* (Germany) | MD05 | Comprises a synthetic carrier linked to recombinant human growth and differentiation factor-5 | Periodontal disease | Gained regulatory approval to begin a Phase II trial (5/23)** |
Tercica Inc. (TRCA) | Increlex | Mecasermin; 10 mg/mL solution for injection | Severe primary insulin-like growth factor-1 deficiency | CMPH adopted a positive opinion recommending European marketing authorization for Increlex (5/25) |
Notes: | ||||
* Privately held. | ||||
CMPH = Committee for Medicinal Products for Human Use; EMEA = European Medicines Agency; MAA = Marketing authorization application; MRP = Mutual Recognition Procedure. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AMEX = American Stock Exchange; ASX = Australian Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; PK = Pink Sheets; TSX = Toronto Stock Exchange. | ||||