Commences Manufacture of New RNAi Therapeutic for Ebola – Guinea Variant
VANCOUVER, Canada I October 21, 2014 I Tekmira Pharmaceuticals Corporation (Nasdaq:TKMR) (TSX:TKM), a leading developer of RNA interference (RNAi) therapeutics, provides an update on its Ebola program. The Company is reporting it has commenced limited GMP manufacture of a new therapeutic specifically targeting the Ebola – Guinea variant, which is the viral variant responsible for the Ebola epidemic currently prevalent in West Africa. Supply of this new product will be available in early December, 2014, for potential use by various collaborators. As definitive agreements are established we will provide updates accordingly.
The genomic sequence of the Ebola virus responsible for the current outbreak in West Africa has been determined from several viral isolates. The Company has completed the design of a modified RNAi therapeutic specifically targeting this viral variant, now termed ‘Ebola-Guinea.’ The ability to rapidly and accurately match the evolving genetic sequences of emerging infectious agents is one of the powerful features of RNAi therapeutics.
In September, we announced our active engagement with an International Consortium led by the International Severe Acute Respiratory and Emerging Infections Consortium (ISARIC), the University of Oxford, with representatives from the WHO, the US Centre for Disease Control (CDC), Médecins Sans Frontières (MSF), Institut Pasteur and others, on plans for potential expedited clinical trials in West Africa. The Wellcome Trust has awarded £3.2 million to the International Consortium to fund this initiative. The award includes funds for the manufacture of investigational therapeutics and to establish an operational clinical trials platform in two or more Ebola Virus Disease (EVD) treatment centers in West Africa. In this initiative, RNAi has been prioritized as a possible investigational therapeutic. However the use of our new product has not yet been confirmed.
As stated previously, the FDA authorized the Company to provide TKM-Ebola for treatment under expanded access protocols to patients with confirmed or suspected Ebola virus infections. The current supply of TKM-Ebola inventory is limited. However, Tekmira intends to continue to provide TKM-Ebola, if requested, to patients with confirmed or suspected Ebola virus infections under this regulatory framework. To date, several patients have been treated with the product and data collected will be provided to the FDA under the Company’s Investigational New Drug Application (IND). We have established a similar framework with Health Canada for the potential use of TKM-Ebola for patients with confirmed or suspected Ebola virus infections.
The Company’s IND for TKM-Ebola remains on partial clinical hold with respect to the multiple ascending dosing in healthy subjects. We expect this matter to be resolved this quarter.
About RNAi and Tekmira’s LNP
RNAi therapeutics have the potential to treat a number of human diseases by “silencing” disease causing genes. The discoverers of RNAi, a gene silencing mechanism used by all cells, were awarded the 2006 Nobel Prize for Physiology or Medicine. RNAi trigger molecules often require delivery technology to be effective as therapeutics. Tekmira believes its LNP technology represents the most advanced and widely adopted delivery technology for the systemic delivery of RNAi triggers. Tekmira’s LNP platform is being utilized in multiple clinical trials in various disease areas by Tekmira and its partners. Tekmira’s LNP technology (formerly referred to as stable nucleic acid-lipid particles or SNALP) encapsulates RNAi triggers with high efficiency in uniform lipid nanoparticles that are effective in delivering these therapeutic compounds to disease sites. Tekmira’s LNP formulations are manufactured by a proprietary method which is robust, scalable and highly reproducible, and LNP-based products have been reviewed by multiple regulatory agencies for use in clinical trials. LNP formulations comprise several lipid components that can be adjusted to suit the specific application.
About Joint Project Manager Medical Countermeasure Systems (JPM-MCS)
This work is being conducted under a $140M contract with the U.S. Department of Defense Joint Project Manager Medical Countermeasure Systems (JPM-MCS). JPM-MCS, a component of the Joint Program Executive Office for Chemical and Biological Defense, aims to provide U.S. military forces and the nation with safe, effective, and innovative medical solutions to counter chemical, biological, radiological, and nuclear threats. JPM-MCS facilitates the advanced development and acquisition of medical countermeasures and systems to enhance biodefense response capability. For more information, visit www.jpeocbd.osd.mil.
About Tekmira
Tekmira Pharmaceuticals Corporation is a biopharmaceutical company focused on advancing novel RNAi therapeutics and providing its leading lipid nanoparticle (LNP) delivery technology to pharmaceutical and biotechnology partners. Tekmira has been working in the field of nucleic acid delivery for over a decade, and has broad intellectual property covering its delivery technology. Further information about Tekmira can be found at www.tekmira.com. Tekmira is based in Vancouver, Canada and Seattle, USA.
SOURCE: Tekmira
Post Views: 29
Commences Manufacture of New RNAi Therapeutic for Ebola – Guinea Variant
VANCOUVER, Canada I October 21, 2014 I Tekmira Pharmaceuticals Corporation (Nasdaq:TKMR) (TSX:TKM), a leading developer of RNA interference (RNAi) therapeutics, provides an update on its Ebola program. The Company is reporting it has commenced limited GMP manufacture of a new therapeutic specifically targeting the Ebola – Guinea variant, which is the viral variant responsible for the Ebola epidemic currently prevalent in West Africa. Supply of this new product will be available in early December, 2014, for potential use by various collaborators. As definitive agreements are established we will provide updates accordingly.
The genomic sequence of the Ebola virus responsible for the current outbreak in West Africa has been determined from several viral isolates. The Company has completed the design of a modified RNAi therapeutic specifically targeting this viral variant, now termed ‘Ebola-Guinea.’ The ability to rapidly and accurately match the evolving genetic sequences of emerging infectious agents is one of the powerful features of RNAi therapeutics.
In September, we announced our active engagement with an International Consortium led by the International Severe Acute Respiratory and Emerging Infections Consortium (ISARIC), the University of Oxford, with representatives from the WHO, the US Centre for Disease Control (CDC), Médecins Sans Frontières (MSF), Institut Pasteur and others, on plans for potential expedited clinical trials in West Africa. The Wellcome Trust has awarded £3.2 million to the International Consortium to fund this initiative. The award includes funds for the manufacture of investigational therapeutics and to establish an operational clinical trials platform in two or more Ebola Virus Disease (EVD) treatment centers in West Africa. In this initiative, RNAi has been prioritized as a possible investigational therapeutic. However the use of our new product has not yet been confirmed.
As stated previously, the FDA authorized the Company to provide TKM-Ebola for treatment under expanded access protocols to patients with confirmed or suspected Ebola virus infections. The current supply of TKM-Ebola inventory is limited. However, Tekmira intends to continue to provide TKM-Ebola, if requested, to patients with confirmed or suspected Ebola virus infections under this regulatory framework. To date, several patients have been treated with the product and data collected will be provided to the FDA under the Company’s Investigational New Drug Application (IND). We have established a similar framework with Health Canada for the potential use of TKM-Ebola for patients with confirmed or suspected Ebola virus infections.
The Company’s IND for TKM-Ebola remains on partial clinical hold with respect to the multiple ascending dosing in healthy subjects. We expect this matter to be resolved this quarter.
About RNAi and Tekmira’s LNP
RNAi therapeutics have the potential to treat a number of human diseases by “silencing” disease causing genes. The discoverers of RNAi, a gene silencing mechanism used by all cells, were awarded the 2006 Nobel Prize for Physiology or Medicine. RNAi trigger molecules often require delivery technology to be effective as therapeutics. Tekmira believes its LNP technology represents the most advanced and widely adopted delivery technology for the systemic delivery of RNAi triggers. Tekmira’s LNP platform is being utilized in multiple clinical trials in various disease areas by Tekmira and its partners. Tekmira’s LNP technology (formerly referred to as stable nucleic acid-lipid particles or SNALP) encapsulates RNAi triggers with high efficiency in uniform lipid nanoparticles that are effective in delivering these therapeutic compounds to disease sites. Tekmira’s LNP formulations are manufactured by a proprietary method which is robust, scalable and highly reproducible, and LNP-based products have been reviewed by multiple regulatory agencies for use in clinical trials. LNP formulations comprise several lipid components that can be adjusted to suit the specific application.
About Joint Project Manager Medical Countermeasure Systems (JPM-MCS)
This work is being conducted under a $140M contract with the U.S. Department of Defense Joint Project Manager Medical Countermeasure Systems (JPM-MCS). JPM-MCS, a component of the Joint Program Executive Office for Chemical and Biological Defense, aims to provide U.S. military forces and the nation with safe, effective, and innovative medical solutions to counter chemical, biological, radiological, and nuclear threats. JPM-MCS facilitates the advanced development and acquisition of medical countermeasures and systems to enhance biodefense response capability. For more information, visit www.jpeocbd.osd.mil.
About Tekmira
Tekmira Pharmaceuticals Corporation is a biopharmaceutical company focused on advancing novel RNAi therapeutics and providing its leading lipid nanoparticle (LNP) delivery technology to pharmaceutical and biotechnology partners. Tekmira has been working in the field of nucleic acid delivery for over a decade, and has broad intellectual property covering its delivery technology. Further information about Tekmira can be found at www.tekmira.com. Tekmira is based in Vancouver, Canada and Seattle, USA.
SOURCE: Tekmira
Post Views: 29
