Clinical Trials Overview
| Preclinical | Phase I | Phase II | Phase III | |
| Liposomal SOD | ||||
| HIV antibodies | ||||
| Live attenuated influenza vaccine | ||||
| Influenza as vector for HIV | ||||
| Influenza as vector for TB | ||||
| Product | Liposomal SOD (Lipoxysan) |
| Phase / Study design | II / open label |
| Indication | Peyronie′s disease |
| Number of patients (total) | 25 |
| Country / Center | Austria / municipal hospital Lainz |
| Principal Investigator | C. Riedl |
| Goal of study / Clinical endpoint | Safety and efficacy of Lipoxysan treatment |
| Status | Completed |
| Product | Liposomal SOD (Lipoxysan) |
| Phase / Study design | III / placebo controlled |
| Indication | Peyronie′s disease |
| Number of patients (total) | 45 |
| Country / Center(s) | Austria / municipal hospital Lainz LKH Graz LKH Klagenfurt |
| Principal Investigator | C. Riedl |
| Goal of study / Clinical endpoints | Significant reduction of pain |
| Status | Completed |
| Product | Liposomal SOD (Lipoxysan) |
| Phase / Study design | II / placebo controlled |
| Indication | Wound healing after Laser therapy |
| Number of patients (total) | 10 |
| Country / Center | Austria / LKH Graz |
| Principal Investigator | W. Aberer |
| Goal of study / Clinical endpoints | Pain reduction, epithelialization |
| Status | Completed |
| Product | rhSOD |
| Phase / Study design | I / open label |
| Indication | --- |
| Number of patients (total) | 18 |
| Country / Center | Austria / AKH Vienna |
| Principal Investigator | M. Wolzt |
| Sponsor | Department of Clinical Pharmacology, Medical University Vienna (Investigator-initiated study) |
| Goal of study / Clinical endpoints | Pharmacokinetics of rh SOD |
| Status | Completed |
| Product | rhSOD |
| Phase / Study design | I / open label |
| Indication | Treatment of inflammation-induced impairment of vascular reactivity |
| Number of patients (total) | 25 |
| Country / Center | Austria / AKH Vienna |
| Principal Investigator | M. Wolzt |
| Sponsor | Department of Clinical Pharmacology, Medical University Vienna (Investigator-initiated study) |
| Goal of study / Clinical endpoints | Forearm blood flow response to vasoactive drugs |
| Status | Completed |
| Product | HIV antibodies C2F5 & C2G12 |
| Phase / Study design | I / open label |
| Indication | HIV infection |
| Number of patients (total) | 7 |
| Country / Center | Austria / Otto Wagner hospital |
| Principal Investigator | N. Vetter / C. Armbruster |
| Goal of study / Clinical endpoints | Safety and pharmacokinetic |
| Status | Completed |
| Product | HIV antibodies C4E10, C2F5 & C2G12 |
| Phase / Study design | I / open label |
| Indication | HIV infection |
| Number of patients (total) | 8 |
| Country / Center | Austria / Otto Wagner hospital |
| Principal Investigator | N. Vetter / C. Armbruster |
| Goal of study / Clinical endpoints | Safety and pharmacokinetic |
| Status | Completed |
| Product | HIV antibodies C4E10, C2F5 & C2G12 |
| Phase / Study design | II / open label, historical control |
| Indication | HIV infection |
| Number of patients (total) | 14 |
| Country / Center | Switzerland / University hospital Zurich |
| Principal Investigator | H. Günthard |
| Goal of study / Clinical endpoints | Delay of viral rebound during STI |
| Status | Completed |
| Product | HIV antibodies C4E10, C2F5 & C2G12 |
| Phase / Study design | I/II / open label |
| Indication | HIV infection |
| Number of patients (total) | 10 |
| Country / Center | USA / ADARC New York |
| Principal Investigator | M. Markowitz |
| Goal of study / Clinical endpoints | Delay of viral rebound during STI |
| Status | Completed |
| Product | Microbicide gel with HIV antibodies C4E10, C2F5 & C2G12 |
| Phase / Study design | I / placebo controlled |
| Indication | HIV prevention |
| Number of patients (total) | 30 |
| Country / Center | UK / York Hospitals NHS Foundation Trust |
| Principal Investigator | C. Lacey |
| Goal of study / Clinical endpoints | Safety and pharmacokinetic |
| Status | Completed |
| Product | Live attenuated influenza vaccine (Vero-Vac) |
| Phase / Study design | I / controlled |
| Indication | Influenza vaccination |
| Number of patients (total) | 91 |
| Country / Center | Russia / St. Petersburg Institute of Influenza Research |
| Principal Investigator | O. Kiselev |
| Goal of study / Clinical endpoints | Safety, immunogenicity |
| Status | Completed |
| Product | Live attenuated influenza vaccine (Vero-Vac) |
| Phase / Study design | I / controlled |
| Indication | Influenza vaccination |
| Number of patients (total) | 111 |
| Country / Center | Russia / St. Petersburg Institute of Influenza Research |
| Principal Investigator | O. Kiselev |
| Goal of study / Clinical endpoints | Safety, immunogenicity |
| Status | Completed |
Publications:
Mehandru S, Vcelar B, Wrin T, Stiegler G, Joos B, Mohri H, Boden D, Galovich J, Tenner-Racz K, Racz P, Carrington M, Petropoulos C, Katinger H, Markowitz M (2007), Adjunctive passive immunotherapy in human immunodeficiency virus type 1-infected individuals treated with antiviral therapy during acute and early infection. J Virol 81(20):11016-31Vcelar B, Stiegler G, Wolf H, Muntean W, Leschnik B, Mehandru S, Markowitz M, Armbruster C, Kunert R, Eibl M, Katinger H (2007) Reassessment of autoreactivity of the broadly neutralizing HIV antibodies 4E10 and 2F5 and retrospective analysis of clinical safety data. AIDS 21(16):2161-2170
Wild T, Budzanowski A, Vcelar B, Wagner A, Vorauer-Uhl K, Katinger H (2006) Successful treatment of a leg ulcer occurring in a rheumatoid arthritis patient under methotrexate therapy by reduction of oxidative stress and nutritional supplementation, Journal of Wound Healing 5/06:258-61
Joos B, Trkola A, Kuster H, Aceto L, Fischer M, Stiegler G, Armbruster C, Vcelar B, Katinger H, Günthard H (2006) Long-Term Multiple-Dose Pharmacokinetics of Human Monoclonal Antibodies (MAbs) against Human Immunodeficiency Virus Type 1 Envelope gp120 (MAb 2G12) and gp41 (MAbs 4E10 and 2F5). Antimicrob Agents Chemother 50(5):1773-9
Riedl CR, Sternig P, Galle G, Langmann F, Vcelar B, Vorauer K, Wagner A, Katinger H, Pflüger H (2005) Liposomal Recombinant Human Superoxide Dismutase for the Treatment of Peyronie′s Disease: A Randomized Placebo-Controlled Double-Blind Prospective Clinical Study. Eur Urol 48(4):656-61
Trkola A, Kuster H, Rusert P, Joos B, Fischer M, Leemann C, Manrique A, Huber M, Rehr M, Oxenius A, Weber R, Stiegler G, Vcelar B, Katinger H, Aceto L, Günthard H (2005) Delay of HIV-1 rebound after cessation of antiretroviral therapy through passive transfer of human neutralizing antibodies, Nature Medicine 11(6):615-22
Armbruster C, Stiegler G, Vcelar B, Jager W, Koller U, Jilch R, Ammann CG, Pruenster M, Stoiber H, Katinger H (2004) Passive immunization with the anti-HIV-1 human monoclonal antibody (hMAb) 4E10 and the hMAb combination 4E10/2F5/2G12. J Antimicrob Chemother 54(5):915-20
Romanova J, Katinger D, Ferko B, Vcelar B, Sereinig S, Kuznetsov O, Stukova M, Erofeeva M, Kiselev O, Katinger H, Egorov A (2004) Live cold-adapted influenza A vaccine produced in Vero cell line. Virus Res 103(1-2):187-93
Armbruster C, Stiegler GM, Vcelar BA, Jager W, Michael NL, Vetter N, Katinger H (2002) A phase Itrial with two human monoclonal antibodies (hMAb 2F5, 2G12) against HIV-1. AIDS 16:227-33
Stiegler G, Armbruster C, Vcelar B, Stoiber H, Kunert R, Michael NL, Jagodzinski LL, Ammann C, Jager W, Jacobson J, Vetter N, Katinger H (2002) Antiviral activity of the neutralizing antibodies 2F5 and 2G12 in asymptomatic HIV-1-infected humans: a phase I evaluation. AIDS 16:2019-25
Riedl CR, Plas E, Vorauer K, Vcelar B, Wagner A, Pflüger H (2001) Pilot study on liposomal recombinant superoxide dismutase for the treatment of Peyronie's disease. Eur Urol 40(3):343-8