Towards NanoMedicine Interventions for HIV/AIDS
Lead Research Organisation:
University of Liverpool
Department Name: Chemistry
Abstract
Nanomedicines have proven extremely valuable in recent years and many are used daily to treat patients with a range of conditions or needs - from the treatment of cancer and menopausal symptoms to the prevention of organ rejection or malnutrition/weight loss. A range of unmet clinical needs may benefit considerably from the research and application of new nanoparticle synthesis techniques and the development of appropriate nanomedicines and provision of scale-able, commercially viable technologies that can impact patient outcomes is a key goal of nanomedicine research.
Validation of new technologies through optimisation of product performance, demonstration of pharmaceutically relevant manufacturing and in-man pharmacokinetic studies is critical for progression as is the study of nanotoxicology to establish a safety assessment that supports future investment.
To date, a series of candidate nanomedicines for HIV/AIDS treatment have been generated at the University of Liverpool in collaboration with IOTA NanoSolutions Ltd, a specialist start-up company in the UK, and supported by RCUK funding. IOTA is commercialising a novel nanoparticle synthesis technology (initially developed at UoL with EPSRC funding support) that rivals the most successful commercial top-down nanomedicine technology - nanomilling. The HIV/AIDS nanomedicine candidates have been the subject of 3 patent filings and funds are sought to optimise their production and establish their behaviour using clinical research techniques. Additionally the project will seek to dramatically increase the understanding of nanomedicine through fundamental mechanistic studies, thereby producing new insight into the mode of action and the safety of future nanomedicines.
If successful, the programme will produce the first nanomedicine options for HIV/AIDS therapy with benefits for patient care potentially including lower dosing, reduced side effects, better patient-to-patient consistency and a reduction of tablet size. Significant interest has been generated within Medecins Sans Frontiere who are keen to utilise the outputs for charitable medicines in the developing world, treating children with HIV infection with better products and prevent HIV infection in newborns. Currently, to prevent transmission of HIV to children from infected mothers, the World Heath Organisation has recommended dosing from 3 weeks after birth with antiretrovirals. The only children's medicines available include high levels of alcohol to dissolve the poorly water-soluble drugs. The nanomedcines within this programme are dispersible in water and offer a step-forward in paediatric therapy.
The successful establishment of the fundamental research underpinning new nanomedicines will provide a clear advance in the UK's global standing in this emerging area, currently valued at >US$75bn and growing rapidly, with expectations to reach >US$100bn within 3 years.
Validation of new technologies through optimisation of product performance, demonstration of pharmaceutically relevant manufacturing and in-man pharmacokinetic studies is critical for progression as is the study of nanotoxicology to establish a safety assessment that supports future investment.
To date, a series of candidate nanomedicines for HIV/AIDS treatment have been generated at the University of Liverpool in collaboration with IOTA NanoSolutions Ltd, a specialist start-up company in the UK, and supported by RCUK funding. IOTA is commercialising a novel nanoparticle synthesis technology (initially developed at UoL with EPSRC funding support) that rivals the most successful commercial top-down nanomedicine technology - nanomilling. The HIV/AIDS nanomedicine candidates have been the subject of 3 patent filings and funds are sought to optimise their production and establish their behaviour using clinical research techniques. Additionally the project will seek to dramatically increase the understanding of nanomedicine through fundamental mechanistic studies, thereby producing new insight into the mode of action and the safety of future nanomedicines.
If successful, the programme will produce the first nanomedicine options for HIV/AIDS therapy with benefits for patient care potentially including lower dosing, reduced side effects, better patient-to-patient consistency and a reduction of tablet size. Significant interest has been generated within Medecins Sans Frontiere who are keen to utilise the outputs for charitable medicines in the developing world, treating children with HIV infection with better products and prevent HIV infection in newborns. Currently, to prevent transmission of HIV to children from infected mothers, the World Heath Organisation has recommended dosing from 3 weeks after birth with antiretrovirals. The only children's medicines available include high levels of alcohol to dissolve the poorly water-soluble drugs. The nanomedcines within this programme are dispersible in water and offer a step-forward in paediatric therapy.
The successful establishment of the fundamental research underpinning new nanomedicines will provide a clear advance in the UK's global standing in this emerging area, currently valued at >US$75bn and growing rapidly, with expectations to reach >US$100bn within 3 years.
Planned Impact
The key focus of the proposal is the collaborative progression of research outputs from RCUK Grand Challenge funding to demonstrated nanomedicines with the potential for further development into products and the delivery of improved patient outcomes. Critical to this is the generation of in man PK data as this validates the research by generating relevant evidence of behaviour in man rather than questionable links from animal models to human performance.
The beneficiaries of the research therefore fall into a number of groups including scientists, clinicians, patients and industry. Within the field of nanomaterials and nanomedicine, a series of ongoing societal and governmental debates are discussing the safety and application of nanoscale technologies. The programme will engage fully with this debate and provide insight and new opinion from the direct outputs of the materials, pharmacology and clinical research proposed, with the potential to impact policy decisions.
The charity Médecins Sans Frontière and the Drugs for Neglected Diseases Initiative are highly committed to evaluating the nanomedicine options for the paediatric dosing in the developing world. This holds the possibility of prevention of mother-to-child transmission as the WHO guidelines recommend a prophylactic dosing of antiretrovirals to new-borns as early as 3 weeks old and for up to 8 years. Provision of relevant formulations has been poor and new options are urgently required to prevent transmission during breastfeeding and into the later years. Adoption of the proposed research outputs in sub-Saharan Africa would impact a growing population of HIV patients and help to slow the increasing numbers of infant infections. Within developed countries, HIV nanomedicines may act to increase patient
compliance and reduce patient variability, thereby providing clinicians with therapies with more predictable clinical outcomes and consistency across varying patient populations. Also, it is a fallacy to believe that HIV is not a concern within the developed world and can be managed as a chronic disease. Infections in teh UK continue to rise alarmingly and maintenance of patient quality of life requires a life-long commitment to a cocktail of drugs with considerable inter-patient variability and side-effects. Although the rate of infection has decreased, the numbers of new infections per year in the UK-alone are still in the thousands and multi-drug resistance (often derived from poor patient compliance) is leaving many patients with fewer therapy options.
If successful, the project will generate therapy options that will be commercially protected and have considerably demonstrated progress towards product manufacture, thereby able to generate future investment. The provision of new data and successful results in this area will show the wide applicability of the nanoparticle synthesis and resulting nanomedicine generation. The project also has the capability to secure the future of a small, high technology company in the North West, building a foundation for considerable investment and commercial revenues. It is also worth noting that outputs from the programme will potentially represent the first nano-antiretroviral commercial therapies after progression to the clinic.
As a platform for future products with a developed supply chain and demonstration of in-man pharmacokinetics, this will generate a significant commercial opportunity for the UK with multiple areas of impact.
The beneficiaries of the research therefore fall into a number of groups including scientists, clinicians, patients and industry. Within the field of nanomaterials and nanomedicine, a series of ongoing societal and governmental debates are discussing the safety and application of nanoscale technologies. The programme will engage fully with this debate and provide insight and new opinion from the direct outputs of the materials, pharmacology and clinical research proposed, with the potential to impact policy decisions.
The charity Médecins Sans Frontière and the Drugs for Neglected Diseases Initiative are highly committed to evaluating the nanomedicine options for the paediatric dosing in the developing world. This holds the possibility of prevention of mother-to-child transmission as the WHO guidelines recommend a prophylactic dosing of antiretrovirals to new-borns as early as 3 weeks old and for up to 8 years. Provision of relevant formulations has been poor and new options are urgently required to prevent transmission during breastfeeding and into the later years. Adoption of the proposed research outputs in sub-Saharan Africa would impact a growing population of HIV patients and help to slow the increasing numbers of infant infections. Within developed countries, HIV nanomedicines may act to increase patient
compliance and reduce patient variability, thereby providing clinicians with therapies with more predictable clinical outcomes and consistency across varying patient populations. Also, it is a fallacy to believe that HIV is not a concern within the developed world and can be managed as a chronic disease. Infections in teh UK continue to rise alarmingly and maintenance of patient quality of life requires a life-long commitment to a cocktail of drugs with considerable inter-patient variability and side-effects. Although the rate of infection has decreased, the numbers of new infections per year in the UK-alone are still in the thousands and multi-drug resistance (often derived from poor patient compliance) is leaving many patients with fewer therapy options.
If successful, the project will generate therapy options that will be commercially protected and have considerably demonstrated progress towards product manufacture, thereby able to generate future investment. The provision of new data and successful results in this area will show the wide applicability of the nanoparticle synthesis and resulting nanomedicine generation. The project also has the capability to secure the future of a small, high technology company in the North West, building a foundation for considerable investment and commercial revenues. It is also worth noting that outputs from the programme will potentially represent the first nano-antiretroviral commercial therapies after progression to the clinic.
As a platform for future products with a developed supply chain and demonstration of in-man pharmacokinetics, this will generate a significant commercial opportunity for the UK with multiple areas of impact.
Organisations
- University of Liverpool (Lead Research Organisation)
- Universidade Federal de Santa Maria (Collaboration)
- UNIVERSITY OF GLASGOW (Collaboration)
- ViiV Healthcare (Collaboration)
- Medicines Patent Pool (Collaboration)
- IOTA Nano Solutions Ltd (Project Partner)
- Drugs for Neglected Diseases Initiative (Project Partner)
Publications
McDonald T
(2015)
Nanoengineering
Steve Rannard (Author)
(2012)
4th Annual Georgia Nanotechnology and Infectious Disease Symposium
Steve Rannard (Author)
(2012)
3rd Annual World Drug Delivery & Formulation Summit
Tatham LM
(2015)
Nanoformulation strategies for the enhanced oral bioavailability of antiretroviral therapeutics.
in Therapeutic delivery
Siccardi M
(2013)
Nanomedicines for HIV therapy.
in Therapeutic delivery
Ricketts K
(2018)
Recommendations for clinical translation of nanoparticle-enhanced radiotherapy.
in The British journal of radiology
Description | The processing of poorly-water soluble antiretrovirals for oral dosing of HIV-patients has been achieved and the team have conducted the world's first oral dosing of nanomedicines to humans with the aim of improving HIV patient dosing. The new approach to formulating nanomedicines has been translated through to pharmaceutical (GMP) manufacture and candidate medicines were made. This validates the potential future value of the manufacturing approach. |
Exploitation Route | The outcomes were taken forward in Project OPTIMIZE - a global consortium funded by the US Agency for International Development led from South Africa |
Sectors | Healthcare Pharmaceuticals and Medical Biotechnology |
Description | The outcomes of the research have generated a collaborative agreement with the UNITAID-funded Medicines Patent Pool - the first academic technology provision to MPP. The successful healthy volunteer trial has led to a tendering for industrial development partners and several have signed CDAs to access further information and detailed discussions. Calculations have shown that the potential reduced doses available could save >$500m in the first 5 years of adoption for global charities and offer potential easing of manufacturing pressure for the global supply chain. |
First Year Of Impact | 2015 |
Sector | Healthcare,Pharmaceuticals and Medical Biotechnology |
Impact Types | Societal Economic |
Description | Inclusion of research outputs in PEPFAR watch list for future HIV therapies |
Geographic Reach | Multiple continents/international |
Policy Influence Type | Citation in other policy documents |
URL | https://www.pepfar.gov/documents/organization/271314.pdf |
Description | Membership of Innovate UK Emerging Technologies and Industries Steering Committee |
Geographic Reach | National |
Policy Influence Type | Membership of a guideline committee |
Description | (REFINE) - Regulatory Science Framework for Nano(bio)material-based Medical Products and Devices |
Amount | € 7,967,941 (EUR) |
Funding ID | 761104 |
Organisation | European Commission |
Sector | Public |
Country | European Union (EU) |
Start | 12/2017 |
End | 11/2021 |
Description | An Injectable Implant Providing Long-Acting Drug Delivery for the Treatment of Chronic disease |
Amount | £931,713 (GBP) |
Funding ID | EP/S012265/1 |
Organisation | Engineering and Physical Sciences Research Council (EPSRC) |
Sector | Public |
Country | United Kingdom |
Start | 03/2019 |
End | 01/2023 |
Description | Antiretroviral Nanoparticles |
Amount | £826,696 (GBP) |
Organisation | Viiv Healthcare |
Sector | Private |
Country | United Kingdom |
Start | 04/2017 |
End | 11/2019 |
Description | Industrial Funding |
Amount | £829,000 (GBP) |
Organisation | Industry Partners |
Sector | Private |
Country | United States |
Start | 03/2017 |
End | 04/2019 |
Description | Industrial Funding - Agrochemicals |
Amount | £572,000 (GBP) |
Organisation | Industry Partners |
Sector | Private |
Country | United States |
Start | 01/2016 |
End | 09/2019 |
Description | Long acting NRTI therapies for HIV |
Amount | £853,313 (GBP) |
Funding ID | R01AI134091 |
Organisation | National Institutes of Health (NIH) |
Sector | Public |
Country | United States |
Start | 06/2017 |
End | 06/2023 |
Description | MRC Funding for Imaging |
Amount | £914,582 (GBP) |
Funding ID | MR/K015931/1 |
Organisation | Medical Research Council (MRC) |
Sector | Public |
Country | United Kingdom |
Start |
Description | NIH Funding from US |
Amount | £87,922 (GBP) |
Organisation | National Institutes of Health (NIH) |
Sector | Public |
Country | United States |
Start |
Description | NIH Funding from US |
Amount | £87,922 (GBP) |
Organisation | National Institutes of Health (NIH) |
Sector | Public |
Country | United States |
Start | 09/2013 |
End | 09/2014 |
Description | Nanoengineered microneedle arrays for enhanced delivery of long-acting HIV medicines |
Amount | £1,095,411 (GBP) |
Funding ID | EP/S028919/1 |
Organisation | Engineering and Physical Sciences Research Council (EPSRC) |
Sector | Public |
Country | United Kingdom |
Start | 09/2019 |
End | 09/2023 |
Description | Project LONGEVITY |
Amount | $4,000,000 (USD) |
Organisation | World Health Organization (WHO) |
Sector | Public |
Country | Global |
Start | 01/2020 |
End | 12/2024 |
Description | US NIH R01 funding |
Amount | $1,210,035 (USD) |
Funding ID | R01AI114405 |
Organisation | National Institutes of Health (NIH) |
Sector | Public |
Country | United States |
Start |
Description | USAID PEPFAR ART Simplification |
Amount | $5,000,000 (USD) |
Funding ID | AID-OAA-A-15-00069 |
Organisation | United States Agency for International Development |
Sector | Public |
Country | United States |
Start | 09/2015 |
End | 09/2020 |
Description | Brazil |
Organisation | Federal University of Santa Maria |
Country | Brazil |
Sector | Academic/University |
PI Contribution | Hosted a visiting scientist from Departamento de Ciências Farmacêuticas, Universidade Federal de Santa Catarina P.O. Box 476, Florianópolis, SC, 88040-900, Brazil to undertake the evaluation of novel nanomaterials intended for drug delivery strategies. The Liverpool team provided hands on training and direct research relating to in vitro immunological characterisation, in vitro drug disposition assays and physiologically-based pharmacokinetic modelling. The collaboration has resulted in two publications. |
Collaborator Contribution | Adny Silva spent a period of 8 months at Liverpool learning various assays for pre-clinical assessment of nanomaterials that were generated by her and her colleagues in Departamento de Ciências Farmacêuticas, Universidade Federal de Santa Catarina P.O. Box 476, Florianópolis, SC, 88040-900, Brazil. The Brazilian collaborators therefore generated the materials and helped characterise them in Liverpool. They also co-wrote the two publications. |
Impact | Silva AH, Locatelli C, Filippin-Monteiro FB, Martin P, Liptrott NJ, Zanetti-Ramos BG, Benetti LC, Nazari EM, Albuquerque CA, Pasa AA, Owen A, Creczynski-Pasa TB. Toxicity and inflammatory response in Swiss albino mice after intraperitoneal and oral administration of polyurethane nanoparticles. Toxicol Lett. 2016 Mar 30;246:17-27. doi: 10.1016/j.toxlet.2016.01.018. Epub 2016 Jan 25. |
Start Year | 2014 |
Description | EU Nanocharacterisation Laboratory |
Organisation | University of Glasgow |
Department | English Language |
Country | United Kingdom |
Sector | Academic/University |
PI Contribution | The University of Liverpool team provide critical expertise developed through EPSRC grant funded activity, to the Horizon 2020 funded European Nanocharcterisation Laboratory |
Collaborator Contribution | Additional input from multiple EU partners to characterise candidate nanomedicines |
Impact | No outputs as yet |
Start Year | 2015 |
Description | Evaluation of solid drug nanoparticles for pharmaceutical benefits |
Organisation | Viiv Healthcare |
Country | United Kingdom |
Sector | Private |
PI Contribution | Proprietary APIs studied for nanoscale drug delivery benefits |
Collaborator Contribution | Provision of proprietary APIs, management of the project and numerous review meetings |
Impact | Numerous evaluations of novel materials for drug delivery |
Start Year | 2015 |
Description | Medicines Patent Pool |
Organisation | Medicines Patent Pool |
Country | Switzerland |
Sector | Private |
PI Contribution | Development of prototype and clinical candidate therapies (nanomedicine) for HIV treatment |
Collaborator Contribution | MPP are seeking partners for scale up and translation of clinical outputs to enable therapy scale up and charitable access |
Impact | None as yet |
Start Year | 2015 |
Title | CHEMICAL COMPOSITION |
Description | A solid composition comprising nanoparticles of atovaquone dispersed within one or more carrier materials, wherein the atovaquone is present in an amount of at least 10 wt %. Also described is an intramuscularly- or subcutaneously-injectable formulation of nanoparticles of atovaquone. |
IP Reference | US2019321310 |
Protection | Patent application published |
Year Protection Granted | 2019 |
Licensed | Commercial In Confidence |
Impact | The patent is under consideration by commercial partners |
Title | CHEMICAL COMPOSITION |
Description | A solid composition comprising nanoparticles of atovaquone dispersed within one or more carrier materials, wherein the atovaquone is present in an amount of at least 10 wt%. Also described is an intramuscularly- or subcutaneously-injectable formulation of nanoparticles of atovaquone. |
IP Reference | WO2017216564 |
Protection | Patent application published |
Year Protection Granted | 2017 |
Licensed | No |
Impact | First demonstration of antimalarial prophylaxis from long acting depot injection. Impact on research approaches and focus of international charities |
Title | COMPOSITIONS OF EFAVIRENZ |
Description | The present inventions relates to a solid composition and an aqueous dispersion comprising nanoparticles of the anti-retroviral drug efavirenz. The solid composition and aqueous dispersion additionally comprise a mixture of a hydrophilic polymer and a surfactant. The surfactant is selected from vitamin-E-polyethylene glycol-succinate (Vit- E-PEG-succinate), a polyoxyethylene sorbitan fatty acid ester, N-alkyldimethylbenzylammonium chloride, sodium deoxycholate, dioctyl sodium sulfosuccinate, polyethyleneglycol-12-hydroxystearate, polyvinyl alcohol (PVA), and a block copolymer of polyoxyethylene and polyoxypropylene, or a combination thereof. The hydrophilic polymer is suitably selected from polyvinyl alcohol (PVA), a polyvinyl alcohol-polyethylene glycol graft copolymer, a block copolymer of polyoxyethylene and polyoxypropylene, polyethylene glycol, hydroxypropyl methyl cellulose (HPMC), and polyvinylpyrrolidone, or a combination thereof. The present invention also relates to processes for preparing both the solid composition and the aqueous dispersion, as well as to their use in therapy for the treatment and/or prevention of retroviral infections such as human immunodeficiency virus (HIV). |
IP Reference | WO2013034925 |
Protection | Patent application published |
Year Protection Granted | 2013 |
Licensed | No |
Impact | The patent is supporting a human clinical trial and has initiated interest from global charities and the NIH (US) |
Title | COMPOSITIONS OF EFAVIRENZ |
Description | The present inventions relates to a solid composition and an aqueous dispersion comprising nanoparticles of the anti-retroviral drug efavirenz. The solid composition and aqueous dispersion additionally comprise a mixture of a hydrophilic polymer and a surfactant. The surfactant is selected from vitamin-E-polyethylene glycol-succinate (Vit- E-PEG-succinate), a polyoxyethylene sorbitan fatty acid ester, N-alkyldimethylbenzylammonium chloride, sodium deoxycholate, dioctyl sodium sulfosuccinate, polyethyleneglycol-12-hydroxystearate, polyvinyl alcohol (PVA), and a block copolymer of polyoxyethylene and polyoxypropylene, or a combination thereof. The hydrophilic polymer is suitably selected from polyvinyl alcohol (PVA), a polyvinyl alcohol-polyethylene glycol graft copolymer, a block copolymer of polyoxyethylene and polyoxypropylene, polyethylene glycol, hydroxypropyl methyl cellulose (HPMC), and polyvinylpyrrolidone, or a combination thereof. The present invention also relates to processes for preparing both the solid composition and the aqueous dispersion, as well as to their use in therapy for the treatment and/or prevention of retroviral infections such as human immunodeficiency virus (HIV). |
IP Reference | WO2013034925 |
Protection | Patent application published |
Year Protection Granted | 2013 |
Licensed | Yes |
Impact | Supporting human clinical trials |
Title | COMPOSITIONS OF EFAVIRENZ |
Description | The present inventions relates to a solid composition and an aqueous dispersion comprising nanoparticles of the anti-retroviral drug efavirenz. The solid composition and aqueous dispersion additionally comprise a mixture of a hydrophilic polymer and a surfactant. The surfactant is selected from vitamin-E-polyethylene glycol-succinate (Vit-E-PEG-succinate), a polyoxyethylene sorbitan fatty acid ester, N-alkyldimethylbenzylammonium chloride, sodium deoxycholate, dioctyl sodium sulfosuccinate, polyethyleneglycol-12-hydroxystearate, polyvinyl alcohol (PVA), and a block copolymer of polyoxyethylene and polyoxypropylene, or a combination thereof. The hydrophilic polymer is suitably selected from polyvinyl alcohol (PVA), a polyvinyl alcohol-polyethylene glycol graft copolymer, a block copolymer of polyoxyethylene and polyoxypropylene, polyethylene glycol, hydroxypropyl methyl cellulose (HPMC), and polyvinylpyrrolidone, or a combination thereof. The present invention also relates to processes for preparing both the solid composition and the aqueous dispersion, as well as to their use in therapy for the treatment and/or prevention of retroviral infections such as human immunodeficiency virus (HIV). |
IP Reference | US2014220140 |
Protection | Patent application published |
Year Protection Granted | 2014 |
Licensed | Yes |
Impact | Licenced to the medicine patent pool and in process to secure commercial development partner |
Title | COMPOSITIONS OF LOPINAVIR |
Description | The present invention relates to a solid composition and an aqueous dispersion comprising nanoparticles of the anti-retroviral drug lopinavir. The solid composition and aqueous dispersion additionally comprise a mixture of a hydrophilic polymer and a surfactant. The surfactant is selected from vitamin-E-polyethylene glycol-succinate (Vit- E-PEG-succinate), a polyoxyethylene sorbitan fatty acid ester, N- alkyldimethylbenzylammonium chloride, sodium deoxycholate, dioctyl sodium sulfosuccinate, polyethyleneglycol-12-hydroxystearate, polyvinyl alcohol (PVA), and a block copolymer of polyoxyethylene and polyoxypropylene, or a combination thereof. The hydrophilic polymer is suitably selected from polyvinyl alcohol (PVA), a polyvinyl alcohol-polyethylene glycol graft copolymer, a block copolymer of polyoxyethylene and polyoxypropylene, polyethylene glycol, hydroxypropyl methyl cellulose (HPMC), and polyvinylpyrrolidone, or a combination thereof. The present invention also relates to processes for preparing both the solid composition and the aqueous dispersion, as well as to their use in therapy for the treatment and/or prevention of retroviral infections such as human immunodeficiency virus (HIV). |
IP Reference | WO2013034926 |
Protection | Patent application published |
Year Protection Granted | 2013 |
Licensed | Yes |
Impact | Currently supporting human clinical trials |
Title | COMPOSITIONS OF LOPINAVIR |
Description | The present invention relates to a solid composition and an aqueous dispersion comprising nanoparticles of the anti-retroviral drug lopinavir. The solid composition and aqueous dispersion additionally comprise a mixture of a hydrophilic polymer and a surfactant. The surfactant is selected from vitamin-E-polyethylene glycol-succinate (Vit- E-PEG-succinate), a polyoxyethylene sorbitan fatty acid ester, N- alkyldimethylbenzylammonium chloride, sodium deoxycholate, dioctyl sodium sulfosuccinate, polyethyleneglycol-12-hydroxystearate, polyvinyl alcohol (PVA), and a block copolymer of polyoxyethylene and polyoxypropylene, or a combination thereof. The hydrophilic polymer is suitably selected from polyvinyl alcohol (PVA), a polyvinyl alcohol-polyethylene glycol graft copolymer, a block copolymer of polyoxyethylene and polyoxypropylene, polyethylene glycol, hydroxypropyl methyl cellulose (HPMC), and polyvinylpyrrolidone, or a combination thereof. The present invention also relates to processes for preparing both the solid composition and the aqueous dispersion, as well as to their use in therapy for the treatment and/or prevention of retroviral infections such as human immunodeficiency virus (HIV). |
IP Reference | WO2013034926 |
Protection | Patent application published |
Year Protection Granted | 2013 |
Licensed | No |
Impact | This patent is underpinning a human clinical trial and has attracted considerable global interest from charities and NIH (US) |
Title | COMPOSITIONS OF LOPINAVIR |
Description | The present invention relates to a solid composition and an aqueous dispersion comprising nanoparticles of the anti-retroviral drug lopinavir. The solid composition and aqueous dispersion additionally comprise a mixture of a hydrophilic polymer and a surfactant. The surfactant is selected from vitamin-E-polyethylene glycol-succinate (Vit-E-PEG-succinate), a polyoxyethylene sorbitan fatty acid ester, N-alkyldimethylbenzylammonium chloride, sodium deoxycholate, dioctyl sodium sulfosuccinate, polyethyleneglycol-12-hydroxystearate, polyvinyl alcohol (PVA), and a block copolymer of polyoxyethylene and polyoxypropylene, or a combination thereof. The hydrophilic polymer is suitably selected from polyvinyl alcohol (PVA), a polyvinyl alcohol-polyethylene glycol graft copolymer, a block copolymer of polyoxyethylene and polyoxypropylene, polyethylene glycol, hydroxypropyl methyl cellulose (HPMC), and polyvinylpyrrolidone, or a combination thereof. The present invention also relates to processes for preparing both the solid composition and the aqueous dispersion, as well as to their use in therapy for the treatment and/or prevention of retroviral infections such as human immunodeficiency virus (HIV). |
IP Reference | US2014212501 |
Protection | Patent application published |
Year Protection Granted | 2014 |
Licensed | Yes |
Impact | Licenced to the medicine patent pool and in process to secure commercial development partner |
Title | COMPOSITIONS OF LOPINAVIR AND RITONAVIR |
Description | The present inventions relates to a solid composition and an aqueous dispersion comprising nanoparticles of the anti-retroviral drugs lopinavir and ritonavir. The solid composition and aqueous dispersion additionally comprise a mixture of a hydrophilic polymer and a surfactant. The surfactant is selected from vitamin-E-polyethylene glycol- succinate (Vit-E-PEG-succinate), a polyoxyethylene sorbitan fatty acid ester, N- alkyldimethylbenzylammonium chloride, sodium deoxycholate, dioctyl sodium sulfosuccinate, polyethyleneglycol-12-hydroxystearate, polyvinyl alcohol (PVA), and a block copolymer of polyoxyethylene and polyoxypropylene, or a combination thereof. The hydrophilic polymer is suitably selected from polyvinyl alcohol (PVA), a polyvinyl alcohol-polyethylene glycol graft copolymer, a block copolymer of polyoxyethylene and polyoxypropylene, polyethylene glycol, hydroxypropyl methyl cellulose (HPMC), and polyvinylpyrrolidone, or a combination thereof. The present invention also relates to processes for preparing both the solid composition and the aqueous dispersion, as well as to their use in therapy for the treatment and/or prevention of retroviral infections such as human immunodeficiency virus (HIV). |
IP Reference | WO2013034927 |
Protection | Patent application published |
Year Protection Granted | 2013 |
Licensed | No |
Impact | Much interest in this patent application as part of a larger portfolio and negotiations to progress to human trials are ongoing |
Title | COMPOSITIONS OF LOPINAVIR AND RITONAVIR |
Description | The present inventions relates to a solid composition and an aqueous dispersion comprising nanoparticles of the anti-retroviral drugs lopinavir and ritonavir. The solid composition and aqueous dispersion additionally comprise a mixture of a hydrophilic polymer and a surfactant. The surfactant is selected from vitamin-E-polyethylene glycol- succinate (Vit-E-PEG-succinate), a polyoxyethylene sorbitan fatty acid ester, N- alkyldimethylbenzylammonium chloride, sodium deoxycholate, dioctyl sodium sulfosuccinate, polyethyleneglycol-12-hydroxystearate, polyvinyl alcohol (PVA), and a block copolymer of polyoxyethylene and polyoxypropylene, or a combination thereof. The hydrophilic polymer is suitably selected from polyvinyl alcohol (PVA), a polyvinyl alcohol-polyethylene glycol graft copolymer, a block copolymer of polyoxyethylene and polyoxypropylene, polyethylene glycol, hydroxypropyl methyl cellulose (HPMC), and polyvinylpyrrolidone, or a combination thereof. The present invention also relates to processes for preparing both the solid composition and the aqueous dispersion, as well as to their use in therapy for the treatment and/or prevention of retroviral infections such as human immunodeficiency virus (HIV). |
IP Reference | WO2013034927 |
Protection | Patent application published |
Year Protection Granted | 2013 |
Licensed | Yes |
Impact | Currently supporting human clinical trials |
Title | COMPOSITIONS OF LOPINAVIR AND RITONAVIR |
Description | The present inventions relates to a solid composition and an aqueous dispersion comprising nanoparticles of the anti-retroviral drugs lopinavir and ritonavir. The solid composition and aqueous dispersion additionally comprise a mixture of a hydrophilic polymer and a surfactant. The surfactant is selected from vitamin-E-polyethylene glycol-succinate (Vit-E-PEG-succinate), a polyoxyethylene sorbitan fatty acid ester, N-alkyldimethylbenzylammonium chloride, sodium deoxycholate, dioctyl sodium sulfosuccinate, polyethyleneglycol-12-hydroxystearate, polyvinyl alcohol (PVA), and a block copolymer of polyoxyethylene and polyoxypropylene, or a combination thereof. The hydrophilic polymer is suitably selected from polyvinyl alcohol (PVA), a polyvinyl alcohol-polyethylene glycol graft copolymer, a block copolymer of polyoxyethylene and polyoxypropylene, polyethylene glycol, hydroxypropyl methyl cellulose (HPMC), and polyvinylpyrrolidone, or a combination thereof. The present invention also relates to processes for preparing both the solid composition and the aqueous dispersion, as well as to their use in therapy for the treatment and/or prevention of retroviral infections such as human immunodeficiency virus (HIV). |
IP Reference | US2014220141 |
Protection | Patent application published |
Year Protection Granted | 2014 |
Licensed | Yes |
Impact | Licenced to the medicine patent pool and in process to secure a commercial development partner |
Title | Chemical composition |
Description | A solid composition comprising nanoparticles of atovaquone dispersed within one or more carrier materials, wherein the atovaquone is present in an amount of at least 10 wt%. Also described is an intramuscularly- or subcutaneously-injectable formulation of nanoparticles of atovaquone. |
IP Reference | AU2017286626 |
Protection | Patent application published |
Year Protection Granted | 2019 |
Licensed | No |
Impact | Subject of a current Unitaid grant application for translation |
Title | PRODRUG COMPOSITIONS |
Description | The present invention provides a composition comprising nanoparticles of prodrugs of certain pharmaceutically active agents, wherein the nanoparticles of prodrugs are dispersed within a carrier material. The present invention further provides processes for the making of the same. |
IP Reference | US2020040015 |
Protection | Patent application published |
Year Protection Granted | 2020 |
Licensed | Commercial In Confidence |
Impact | The patent is under evaluation by commercial partners |
Title | PRODRUG COMPOSITIONS |
Description | The present invention provides a composition comprising nanoparticles of prodrugs of certain pharmaceutically active agents, wherein the nanoparticles of prodrugs are dispersed within a carrier material. The present invention further provides processes for the making of the same. |
IP Reference | WO2018178722 |
Protection | Patent application published |
Year Protection Granted | 2018 |
Licensed | No |
Impact | Current discussions ongoing with a potential commercial partner |
Title | SOLID COMPOSITIONS OF ACTIVES, PROCESSES FOR PREPARING SAME AND USES OF SUCH SOLID COMPOSITIONS |
Description | The present invention provides a solid maraviroc composition, comprising nanoparticles including maraviroc dispersed within a mixture of at least one hydrophilic polymer and at least one surfactant; wherein the hydrophilic polymer is selected from polyvinyl alcohol (PVA), a polyvinyl alcohol-polyethylene glycol graft copolymer, polyethylene glycol, hydroxypropyl methyl cellulose (HPMC) and polyvinylpyrrolidone (PVP), or a combination thereof; and the surfactant is selected from a polyoxyethylene sorbitan fatty acid ester, sodium deoxycholate, dioctyl sodium sulfosuccinate and polyethyleneglycol-12-hydroxystearate, polyvinyl alcohol (PVA) or a combination thereof. |
IP Reference | US2019269662 |
Protection | Patent application published |
Year Protection Granted | 2019 |
Licensed | Commercial In Confidence |
Impact | The patent is under consideration by commercial partners |
Title | Human trial of candidate nanomedicine for HIV using Efavirenz |
Description | Human study of pharmacokinetics of orally dosed nanoparticles of efavirenz aiming at dose and pill burden reduction. Engagement with international charities (Clinton Health Access Initiative; Medicines Patent Pool, MSF) and further funding from NIH (collaboration with Johns Hopkins Medical School) and USAID (Multinational collaboration) to establish potential in other HIV related areas and malarial opportunities. |
Type | Therapeutic Intervention - Drug |
Current Stage Of Development | Early clinical assessment |
Year Development Stage Completed | 2016 |
Development Status | Actively seeking support |
Clinical Trial? | Yes |
Impact | Awaiting outcomes |
URL | https://clinicaltrials.gov/ct2/show/NCT02631473 |
Title | Oral Nanomedicine for HIV using Lopinavir |
Description | This is an nanomedicine for HIV therapy aiming to dramatically reduce the dose and the overall pill burden for HIV sufferers. There is also potential for paediatric therapy development. |
Type | Therapeutic Intervention - Drug |
Current Stage Of Development | Early clinical assessment |
Year Development Stage Completed | 2016 |
Development Status | Actively seeking support |
Clinical Trial? | Yes |
Impact | Licence agreement signed with UNITAID-funded Medicines Patent Pool (Geneva) and considerable additional funding to establish potential within other drugs for HIV (USAID multinational collaboration) and malaria (interatction with Johns Hopkins Medical School). In addition, significant engagement with Clinton Health Access Initiative and the securing of an R01 grant from NIH to study long acting HIV nanomedicines with a team from Johns Hopkins Medical School. |
URL | https://clinicaltrials.gov/ct2/show/NCT02631473 |
Company Name | Tandem Nano |
Description | Tandem Nano develops nanomedicine technologies for the delivery of poorly-soluble medicinal compounds, focusing on using nanoparticles to deliver drugs directly to specific cells or the blood. |
Year Established | 2014 |
Impact | The company has engaged with major multinational industries and is progressing options towards commercial exploitation |
Website | http://www.tandemnano.com |
Company Name | Tandem Nano |
Description | Tandem Nano develops nanomedicine technologies for the delivery of poorly-soluble medicinal compounds, focusing on using nanoparticles to deliver drugs directly to specific cells or the blood. |
Year Established | 2014 |
Impact | Currently negotiating meaningful interactions with numerous global companies |
Website | http://www.tandemnano.com |
Company Name | Tandem Nano |
Description | Tandem Nano develops nanomedicine technologies for the delivery of poorly-soluble medicinal compounds, focusing on using nanoparticles to deliver drugs directly to specific cells or the blood. |
Year Established | 2014 |
Impact | None to date |
Website | http://www.tandemnano.com |
Description | Academic outreach |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | Regional |
Primary Audience | Postgraduate students |
Results and Impact | Research Seminar (invited) to inform audience of Nanomedicine and impact of new therapeutic research |
Year(s) Of Engagement Activity | 2018 |
Description | Colorectal Therapies Healthcare Technologies Co-operative Workshop Nanoparticle-Enhanced Radiotherapy, UCL, London 27th October 2017 |
Form Of Engagement Activity | A formal working group, expert panel or dialogue |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Professional Practitioners |
Results and Impact | Dissemination and discussion of optimal approaches that may be taken for therapy options for colorectal cancer |
Year(s) Of Engagement Activity | 2017 |
Description | Industrial engagement in ongoing research activities |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Industry/Business |
Results and Impact | Solid drug nanoparticle technology evaluation for industrial uptake |
Year(s) Of Engagement Activity | 2018,2019 |
Description | Meeting to discuss research outputs with Global Charity (Clinton Health Access Initiative) |
Form Of Engagement Activity | A formal working group, expert panel or dialogue |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Third sector organisations |
Results and Impact | Activity was used to engage with the Clinton Health Access Initiative to receive support and garner interest in translational activities directed at candidate global HIV nanomedicine therapy development |
Year(s) Of Engagement Activity | 2015 |
Description | Meeting with industry (Revolymer) |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | Local |
Primary Audience | Industry/Business |
Results and Impact | Engagement with research activities and future licence/collaborative research opportunities |
Year(s) Of Engagement Activity | 2015 |
Description | Meetings with Medicines Patent Pool (Geneva) |
Form Of Engagement Activity | A formal working group, expert panel or dialogue |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Third sector organisations |
Results and Impact | Discussions to evaluate licence opportunities to allow translation of research outputs through charitable funding and generic pharma companies. MPP are UNITAID funded |
Year(s) Of Engagement Activity | 2014,2015 |
Description | Pint of Science |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | Regional |
Primary Audience | Public/other audiences |
Results and Impact | The international Pint of Science public engagement science festival aiming to communicate contemporary scientific developments to the general public in an interesting, engaging and approachable way by bringing scientists to the pub and other accessible places. |
Year(s) Of Engagement Activity | 2017 |
URL | https://news.liverpool.ac.uk/2017/04/03/drink-think-pint-science-festival-coming-liverpool/ |
Description | Princes Teaching Institute CPD |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Schools |
Results and Impact | CPD for teachers. Presentation designed to update teachers with up to date information to allow teaching knowledge in Nanomedicine |
Year(s) Of Engagement Activity | 2014 |
Description | Schools Outreach activity |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | Regional |
Primary Audience | Schools |
Results and Impact | Vardean College/RSC Sixth former science meeting. Engagement with 6th formers to explain current progress in Nanomedicine |
Year(s) Of Engagement Activity | 2016 |
Description | University of Liverpool Open House |
Form Of Engagement Activity | Participation in an activity, workshop or similar |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Public/other audiences |
Results and Impact | Public engagement activity to engage public with UoL research and Nanomedicine |
Year(s) Of Engagement Activity | 2018 |
Description | Website for the British Society for Nanomedicine |
Form Of Engagement Activity | A magazine, newsletter or online publication |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Public/other audiences |
Results and Impact | As part of the creation and launch of the British Society for Nanomedicine as website has been created allowing access to information for children, schools, the public and scientists (academic and industrial) The Society now has >300 members globally and has held multiple meetings |
Year(s) Of Engagement Activity | 2012 |