www.bioworld.com/articles/459042
Non-U.S. Clinical Trials And Regulatory Actions: May 2006
June 19, 2006
| Company* (Country; Symbol) | Product | Description | Indication | Status (Date) |
| AUTOIMMUNE | ||||
| BioMS Medical Corp. (Canada; TSE:MS) | MBP8298 | Synthetic peptide | Multiple sclerosis | Monitors in their fourth review of pivotal Phase II/III trial in secondary progressive MS recommended continuation of the study (5/3) |
| Chelsea Therapeutics International Ltd. (CHTP) | CH-1504 | Orally available antifolate compound | Rheumatoid arthritis | Pilot study in 20 patients in Peru demonstrated safety, tolerability and efficacy (5/25) |
| ImmuPharma plc (UK; LSE:IMM) | IPP-201101 | Agent that modulates the signaling of CD4+ cells | Lupus | Successfully completed Phase I trial in France and began Phase II proof-of-concept and efficacy study in Europe (5/10) |
| CANCER | ||||
| Advaxis Inc. (OTC BB:ADXS) | Lovaxin C | Listeria-based cancer vaccine | Cervical cancer | Began Phase I/II trials that will enroll 20 patients at sites in Israel, Serbia and Mexico (5/2) |
| Bioenvision Inc. (BIVN) | Evoltra (FDA-approved) | Clofarabine; second- generation purine nucleoside analogue | Pediatric acute lymphoblastic leukemia | The product was approved in Europe for treating ALL in pediatric patients who have relapsed or are refractory to at least two prior regimens (5/31) |
| Chemokine Therapeutics Corp. (Canada; OTC BB:CHKT) | CTCE-9908 | Chemokine CXCR4 antagonist | Cancers | Began Phase Ib/II trial in Canada to evaluate safety and preliminary efficacy in up to 30 patients with late-stage cancers (5/2) |
| Genentech Inc. (NYSE:DNA) | Herceptin (FDA-approved) | Trastuzumab; monoclonal antibody against the HER2/neu protein | Early stage breast cancer | Partner F. Hoffmann-La Roche Ltd. gained approval in Europe in that additional indication (5/24) |
| Immutep SA* (France) | ImmuFact IMP321 | T-cell immunostimulatory factor designed to amplify immune responses in therapeutic vaccines | Cancers and viral diseases | Phase I trials in 108 healthy volunteers in France demonstrated safety and tolerability, alone and with antigens (5/30) |
| OncoGenex Technologies Inc.* (Canada) and Isis Pharmaceuticals Inc. (ISIS) | OGX-011 | Second-generation anti-sense drug designed to inhibit the production of clusterin, a cell-survival protein | Non-small-cell lung cancer | Eight of 9 patients in Phase I trial with gemcitabine and cisplatin showed either a partial response or stable disease; tolerability also was demonstrated (5/3) |
| Peplin Ltd. (Australia; ASX:PEP) | PEP005 Topical | Agent designed to kill cancer cells and stimulate an immune response | Superficial basal cell carcinoma | Phase IIa trial in Australia showed a statistically significant 71% reduction in sBCC tumors (5/1) |
| Prima BioMed Ltd. (Australia; ASX:PRR) | CVac | Autologous, mucin-1- based dendritic cell therapy | Ovarian cancer | Interim analysis from Phase IIa trial in advanced patients showed 21% of them had either a clinical response or disease stabilization (5/16) |
| Provectus Pharmaceuticals Inc. (OTC BB:PVCT) | PV-10 (Provecta) | Agent designed to be retained in tumor cells while leaving normal tissue unharmed | Metastatic melanoma | Phase I trial in 20 subjects in Australia demonstrated safety and evidence of efficacy (5/15) |
| PTC Therapeutics Inc.* | PTC299 | Small-molecule compound designed to inhibit vascular endothelial growth factor in tumors | Cancer | Began Phase Ia trial in Belgium to evaluate safety and pharmaco-kinetics in healthy volunteers (5/12) |
| CENTRAL NERVOUS SYSTEM | ||||
| Antipodean Pharmaceuticals Inc.* | MitoQ | Mitoquinone; antioxidants delivered by targeted lipophilic cations | Parkinson's disease | Began Phase II trial in Australia and New Zealand that will evaluate efficacy (5/25) |
| Celtic Pharmaceutical Holdings LP* (Bermuda) | TA-NIC | Vaccine designed to raise anti-nicotine antibodies | Nicotine addiction | Is starting a Phase II trial that will enroll more than 400 patients in Europe (5/8) |
| INFECTION | ||||
| BioInvent International AB (Sweden; SSE:BINV) | BI-201 | Human antibody that binds to the TAT protein | HIV | Phase I/IIa trial showed tolerability but no reduction of HIV levels; it plans to test more patients at higher doses (5/29) |
| Crucell NV (the Netherlands; CRXL) | -- | Three different vaccine formulations, all based on the H9N2 virus | Avian influenza | Began study in the UK to assess safety and immunogenicity of the vaccines in 560 healthy adults (5/31) |
| Intercell AG (Austria; VSE:ICLL) | -- | Inactivated vaccine against Japanese encephalitis virus | Japanese encephalitis virus | Pivotal Phase III trial in 868 subjects met primary endpoint of demonstrating immunogenicity (5/31) |
| MISCELLANEOUS | ||||
| Tercica Inc. (TRCA) | Increlex (FDA-approved) | Mecasermin injection; recombinant human insulin-like growth factor-1 | Primary IGF-1 deficiency | The product was granted orphan status in Europe in that indication (5/31) |
| Manhattan Pharmaceuticals Inc. (AMEX:MHA) | OE | Oral administered, synthetic form of form of Oleoyl-estrone | Obesity | Is starting Phase IIa trial in 100 subjects in Switzerland to assess safety, preliminary efficacy and pharmacokinetics (5/16) |
| Notes: | ||||
| * Privately held. | ||||
| MAA = Marketing authorization application; MRP = Mutual Recognition Procedure; EMEA = European Medicines Agency. | ||||
| 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; SSE = Stockholm Stock Exchange; TSE = Toronto Stock Exchange; VSE = Vienna Stock Exchange. | ||||