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Arrowhead Research White Paper - RNAi
I just read this whitepaper from a research firm in Southern California. Looks like some promising stuff is in the pipeline for us chronically infected patients. Any thoughts?
http://www.arrowheadresearch.com/pdf/whitepaper-hbv-3-7-12.pdf
Arrowhead Research Corporation and Axolabs GmbH Enter into Strategic Alliance and Master Services Agreement for RNAi Therapeutics
PASADENA, Calif. — March 5, 2012 — Arrowhead Research Corporation, a nanomedicine company with development programs in RNAi therapeutics and obesity, and Axolabs GmbH, a custom research organization offering preclinical solutions and consultancy in the field of oligonucleotide therapeutics, today announced that they have entered into a Strategic Alliance and Master Services Agreement.
Under the terms of the agreement, Axolabs, founded by the principals of former Roche Center of Excellence for RNAi Therapeutics in Kulmbach, Germany, will provide Arrowhead and its partners first-in-class oligonucleotide optimization, synthesis, and analytics. These services include bioinformatics for siRNA design; lead identification, optimization and characterization; as well as siRNA synthesis and CMC-related activities.
"With multiple candidates in the clinic addressing a wide range of indications, data demonstrating the power of RNAi as a therapeutic modality are rapidly accumulating," said Dr. Christopher Anzalone, Arrowhead's CEO. "Axolabs' scientists are pioneers in the field. Having access to their expertise in preclinical development complements Arrowhead's capabilities well and provides us with yet another tool for preclinical and clinical collaborations in the field. Now, with the company's already established intellectual property position and array of proprietary delivery technologies including Dynamic PolyConjugates™ and RONDEL™, Arrowhead is uniquely positioned to build its own pipeline of RNAi therapeutics and provide partners entry to this promising area in a rapid and cost effective manner."
"This agreement continues the execution of Axolabs' strategy to become the preeminent custom research organization in the oligonucleotide therapeutics field," added Dr. Roland Kreutzer, Managing Director of Axolabs GmbH. "We know the colleagues at Arrowhead very well. We are happy to support them in establishing a leading role in the area of RNAi therapeutics and excited to be chosen as their preclinical service provider."
http://www.arrowheadresearch.com/pdf/whitepaper-hbv-3-7-12.pdf
Arrowhead Research Corporation and Axolabs GmbH Enter into Strategic Alliance and Master Services Agreement for RNAi Therapeutics
PASADENA, Calif. — March 5, 2012 — Arrowhead Research Corporation, a nanomedicine company with development programs in RNAi therapeutics and obesity, and Axolabs GmbH, a custom research organization offering preclinical solutions and consultancy in the field of oligonucleotide therapeutics, today announced that they have entered into a Strategic Alliance and Master Services Agreement.
Under the terms of the agreement, Axolabs, founded by the principals of former Roche Center of Excellence for RNAi Therapeutics in Kulmbach, Germany, will provide Arrowhead and its partners first-in-class oligonucleotide optimization, synthesis, and analytics. These services include bioinformatics for siRNA design; lead identification, optimization and characterization; as well as siRNA synthesis and CMC-related activities.
"With multiple candidates in the clinic addressing a wide range of indications, data demonstrating the power of RNAi as a therapeutic modality are rapidly accumulating," said Dr. Christopher Anzalone, Arrowhead's CEO. "Axolabs' scientists are pioneers in the field. Having access to their expertise in preclinical development complements Arrowhead's capabilities well and provides us with yet another tool for preclinical and clinical collaborations in the field. Now, with the company's already established intellectual property position and array of proprietary delivery technologies including Dynamic PolyConjugates™ and RONDEL™, Arrowhead is uniquely positioned to build its own pipeline of RNAi therapeutics and provide partners entry to this promising area in a rapid and cost effective manner."
"This agreement continues the execution of Axolabs' strategy to become the preeminent custom research organization in the oligonucleotide therapeutics field," added Dr. Roland Kreutzer, Managing Director of Axolabs GmbH. "We know the colleagues at Arrowhead very well. We are happy to support them in establishing a leading role in the area of RNAi therapeutics and excited to be chosen as their preclinical service provider."
They are leaving out people with hbv right close to them with all that they have available. Somehow I dont see it as trying to help. They have the medicine it works dose can be optimised based on labs and how patients feel on the medication.
the next time you see dr.Gish mention this forum. And let him come here and participate.
Also ask for expansion of clinical trials criteria for GS9620 - THEY JUST HAVE TO GIVE IT TO AS MANY PEOPLE AS THEY CAN.
Also ask for expansion of clinical trials criteria for GS9620 - THEY JUST HAVE TO GIVE IT TO AS MANY PEOPLE AS THEY CAN.
Tarmogen Technology is a technology that allows you to design and produce (using yeast) a specific immunogenic protein to be used in your vaccine. So Gilead with use Tarmogen Technology to design the vaccine they want to use.
If I remember correct Gilead and GlobeImmune look for a vaccine that will be use together with Tnf (or maybe new Tnf) and target a finite therapy for HBV.
Gilead will came with Tenofovir (or New Tenofovir) and GlobeImmune will came with Tarmogen.
So, I think that the vaccine will be based on Tarmogen (stimulating the immune system) - http://www.globeimmune.com/technology/
Gilead will came with Tenofovir (or New Tenofovir) and GlobeImmune will came with Tarmogen.
So, I think that the vaccine will be based on Tarmogen (stimulating the immune system) - http://www.globeimmune.com/technology/
The 4 questions are:
1. Gilead
FINITE CHB - First Investigation in Stopping Tenofovir Disoproxil Fumarate (TDF) Treatment After Long Term Virologic Suppression in HBeAg-negative Chronic Hepatitis B.
Purpose
Withdrawal of antiviral therapy can result in hepatic or alanine aminotransferase (ALT) flares as Hepatitis B Virus (HBV) replication resumes; however, in some patients, a flare exacerbates chronic hepatitis temporarily but can also result in viral clearance. Hepatic flares are common after stopping anti-HBV therapy. Only patients who already are on treatment with tenofovir disoproxil fumarate (TDF) for at least 4 years and who achieved and maintained virologic suppression (< 400 copies/mL) for 3.5 or more years will be included in this study. One treatment arm will stop the TDF therapy while the other treatment arm will continue the TDF therapy. Patients who stop TDF (Arm A) will be monitored very closely with special focus on biochemical flares (especially ALT increases) and virological relapses (Hepatitis B viral load increases). If any subject in the stop therapy arm exceeds one or more predefined limits for such flares or relapses, TDF will be reinstituted. The study will assess Hepatitis B surface antigen (HBsAg) loss (i.e. specific Hepatitis B virus components are no longer detectable) and seroconversion (occurrence of Hepatitis B surface antibody, a specific antibody which usually occurs after HBsAg loss) rates during study duration. The percentage of patients who need to restart TDF therapy in the stop arm will also be evaluated.
2. A more potent form of TDF? I read somewhere on these forums about some type of TDF in development that may be able to be used in much less of a dose, thus reducing any adverse affects/long term problems. Is that what you are referring to? YES.
Question is whether this more potent form of Tenofovir will be more efficacious for HBV then existing Tenofovir?
3. Gilead's therapeutic vaccine? Elaborate? I remember when I saw Dr. Gish last month, he did mention that Gilead is working on some therapeutic that would be taken very short term, thus eliminating the need for lifelong medication. Is this what you are referring to? Not sure, Dr Gish could be referring to GS9620 (TLR7 agonist) or a new therapeutic vaccine based on its collaboration with GlobeImmune.
4. A new questions. Gilead's new HBV drug GS9620. At first, I thought it is the clinical trial of this drug that Dr Gish was talking to you about. I think Gilead has completed a Phase 1 or 2 clinical trial already.
Please keep us informed.
1. Gilead
FINITE CHB - First Investigation in Stopping Tenofovir Disoproxil Fumarate (TDF) Treatment After Long Term Virologic Suppression in HBeAg-negative Chronic Hepatitis B.
Purpose
Withdrawal of antiviral therapy can result in hepatic or alanine aminotransferase (ALT) flares as Hepatitis B Virus (HBV) replication resumes; however, in some patients, a flare exacerbates chronic hepatitis temporarily but can also result in viral clearance. Hepatic flares are common after stopping anti-HBV therapy. Only patients who already are on treatment with tenofovir disoproxil fumarate (TDF) for at least 4 years and who achieved and maintained virologic suppression (< 400 copies/mL) for 3.5 or more years will be included in this study. One treatment arm will stop the TDF therapy while the other treatment arm will continue the TDF therapy. Patients who stop TDF (Arm A) will be monitored very closely with special focus on biochemical flares (especially ALT increases) and virological relapses (Hepatitis B viral load increases). If any subject in the stop therapy arm exceeds one or more predefined limits for such flares or relapses, TDF will be reinstituted. The study will assess Hepatitis B surface antigen (HBsAg) loss (i.e. specific Hepatitis B virus components are no longer detectable) and seroconversion (occurrence of Hepatitis B surface antibody, a specific antibody which usually occurs after HBsAg loss) rates during study duration. The percentage of patients who need to restart TDF therapy in the stop arm will also be evaluated.
2. A more potent form of TDF? I read somewhere on these forums about some type of TDF in development that may be able to be used in much less of a dose, thus reducing any adverse affects/long term problems. Is that what you are referring to? YES.
Question is whether this more potent form of Tenofovir will be more efficacious for HBV then existing Tenofovir?
3. Gilead's therapeutic vaccine? Elaborate? I remember when I saw Dr. Gish last month, he did mention that Gilead is working on some therapeutic that would be taken very short term, thus eliminating the need for lifelong medication. Is this what you are referring to? Not sure, Dr Gish could be referring to GS9620 (TLR7 agonist) or a new therapeutic vaccine based on its collaboration with GlobeImmune.
4. A new questions. Gilead's new HBV drug GS9620. At first, I thought it is the clinical trial of this drug that Dr Gish was talking to you about. I think Gilead has completed a Phase 1 or 2 clinical trial already.
Please keep us informed.
Resiquimod is much much more potent than Imiquimod, but its development was abandoned because of severe side effects.
The Gilead TLR7 drug woodchuck study presented at Orlando br Dr. Stefan Menne was truly impressive in its effect on the viral load, the same as with the control antiviral and therefore maybe the most potent non antiviral drug in the pipeline. A combo with an antiviral is likely to be truly synergistic.
The effect could well be way beyond a mere activation of Macrophages and dendritic cells, the cytokine response cocktail produced might be activating paralyzed Tcells inducing them to produce effective IFNgamma concentrations. Even more fascinating is the possibility that the hepatocytes are reacting directly wiith their own TLR, eliciting a complex mix of intracellular antiviral mechanisms that are the true actors upon the intracellular virus machinery just like in response to IFNalpha or gamma.
This direct hepatocyte TLR response was in itself a major discussion at the conference.
Any dosing of the Aldara cream is difficult to predict, most likely the systemic effects are what would matter here. When Dr. Menne was asked if the Gilead TLR agonist drug was chemically related to Imiquimod or Resiquimod, he said he is not allowed to comment. It is entirely possible that this cream would have the same effect if used and dosed properly, but only a well designed clinical trial can answer such a question.
The Gilead TLR7 drug woodchuck study presented at Orlando br Dr. Stefan Menne was truly impressive in its effect on the viral load, the same as with the control antiviral and therefore maybe the most potent non antiviral drug in the pipeline. A combo with an antiviral is likely to be truly synergistic.
The effect could well be way beyond a mere activation of Macrophages and dendritic cells, the cytokine response cocktail produced might be activating paralyzed Tcells inducing them to produce effective IFNgamma concentrations. Even more fascinating is the possibility that the hepatocytes are reacting directly wiith their own TLR, eliciting a complex mix of intracellular antiviral mechanisms that are the true actors upon the intracellular virus machinery just like in response to IFNalpha or gamma.
This direct hepatocyte TLR response was in itself a major discussion at the conference.
Any dosing of the Aldara cream is difficult to predict, most likely the systemic effects are what would matter here. When Dr. Menne was asked if the Gilead TLR agonist drug was chemically related to Imiquimod or Resiquimod, he said he is not allowed to comment. It is entirely possible that this cream would have the same effect if used and dosed properly, but only a well designed clinical trial can answer such a question.
although about cancer there is interesting data on resiquimode and
Imiquimod
http://theoncologist.alphamedpress.org/content/13/8/859.full.pdf+html
The Use of TLR7 and TLR8 Ligands for the Enhancement of Cancer
Immunotherapy
Could you please recap what your 3 questions are?
1. I've read about Gilead's study to stop TDF and then restart it as a method of treatment to get HBsAg clearance - though from the study I looked at there were no Asians with any success in clearance, it was only caucasian.
2. A more potent form of TDF? I read somewhere on these forums about some type of TDF in development that may be able to be used in much less of a dose, thus reducing any adverse affects/long term problems. Is that what you are referring to?
3. Gilead's therapeutic vaccine? Elaborate? I remember when I saw Dr. Gish last month, he did mention that Gilead is working on some therapeutic that would be taken very short term, thus eliminating the need for lifelong medication. Is this what you are referring to?
I will make sure to follow up with your specific questions.
1. I've read about Gilead's study to stop TDF and then restart it as a method of treatment to get HBsAg clearance - though from the study I looked at there were no Asians with any success in clearance, it was only caucasian.
2. A more potent form of TDF? I read somewhere on these forums about some type of TDF in development that may be able to be used in much less of a dose, thus reducing any adverse affects/long term problems. Is that what you are referring to?
3. Gilead's therapeutic vaccine? Elaborate? I remember when I saw Dr. Gish last month, he did mention that Gilead is working on some therapeutic that would be taken very short term, thus eliminating the need for lifelong medication. Is this what you are referring to?
I will make sure to follow up with your specific questions.
thanks for the"Aldara cream" post
i was thinking to try it since maybe it may have an effect together with the macrophages activation from gcmaf
do you have an idea of best way, area and dose to use?
what about using the cream just before or after the gcmaf injection in the same skin site, so that marophages are all activated when also the cream gets absorbed?
my knowledge of immune system is so poor that i have no idea about what the mix of macrophages activation from gcmaf and the cream can do togehter.i read the trl7 should be on macrophages too right?
what about resiquimod?
i saw it is produced and sold for research purpose while any development of this compound is blocked despite the good results on the herpes human trials and the oral version used on hcv human trial
You may be proven right about therapeutic vaccines.
Two Chinese HBV therapeutic vaccines failed, in Phase 2 and Phase 3 clinical trials respectively, already. One uses a peptide of some kind and the other YIC (HBsAg-HBsAb immune complex). The peptide vaccine is still going on in a Phase 2 trial in combination with Entecavir.(The standalone peptide vaccine achieved 30% HbeAg seroconversion, same as the control group, no-one has offered any explanation).
Yesterday, Dr Mamun-Al-Mahtab, Bangladesh, gave a presentation on NASVAC (nasal vaccine using HbsAg + HbcAg) in a biotechnolgy conference in Cuba. He is in charge of a phase 3 clinical trial of NASVAC + Peginterferon. NASVAC is from Cuba and the Cuban press have touted it as giving a better response than existing treatments. I am hoping to see the abstract of the presentation, but so far the proceedings from the conference have not yet been published. BTW ,Dr Mamun-Al-Mahtab is also the doctor in charge of the REP9AC clinical trial in Bangladesh.
Two Chinese HBV therapeutic vaccines failed, in Phase 2 and Phase 3 clinical trials respectively, already. One uses a peptide of some kind and the other YIC (HBsAg-HBsAb immune complex). The peptide vaccine is still going on in a Phase 2 trial in combination with Entecavir.(The standalone peptide vaccine achieved 30% HbeAg seroconversion, same as the control group, no-one has offered any explanation).
Yesterday, Dr Mamun-Al-Mahtab, Bangladesh, gave a presentation on NASVAC (nasal vaccine using HbsAg + HbcAg) in a biotechnolgy conference in Cuba. He is in charge of a phase 3 clinical trial of NASVAC + Peginterferon. NASVAC is from Cuba and the Cuban press have touted it as giving a better response than existing treatments. I am hoping to see the abstract of the presentation, but so far the proceedings from the conference have not yet been published. BTW ,Dr Mamun-Al-Mahtab is also the doctor in charge of the REP9AC clinical trial in Bangladesh.
While the idea of activating specific immunity by therapeutic vaccination to the HBV proteins to combine with antivirals sound good, all the intense efforts to generate such a vaccine have thus far failed to give promising results. Even the strongest effort to combine the HBV Protein components into a poxvirus carrier virus ("modified Vaccinia Virus Ankara") that has been tried by Oxxon Pharmaceuticals using the British Tropical Research Institutes station in the Gambias has failed despite intense painful local reactions in the patients participating .
Strong adjuvant effects are needed to generate an increased response to what is already in existence in a patient that is constantly flooded inside with these HBV antigens anyway..
Similarily, all the HCV therapeutic vaccine efforts, the strongest ever was made by Intercell in Austria, have failed to achieve anything more than a noticable increase in the response to the HCV antigen components injected, however with very little effect on viral loads.
Strong adjuvant effects are needed to generate an increased response to what is already in existence in a patient that is constantly flooded inside with these HBV antigens anyway..
Similarily, all the HCV therapeutic vaccine efforts, the strongest ever was made by Intercell in Austria, have failed to achieve anything more than a noticable increase in the response to the HCV antigen components injected, however with very little effect on viral loads.
Each RNAi is designed specifically to induce cutting ( the"dicer") and destruction of messenger RNA for each gene product. As such for example, the surface antigen messenger and therefore the surface antigen translation and protein production could be reduced, hopefully to almost zero.
A mix of different RNAis for each message could reduce several components of the virions production as well as the accessory proteins (eAntigen and HBsAg) independently and in a collaborative fashion. The replication is only indirectly affected as much as its components - genomic RNA, core and Polymerase can be reduced, but not the process of building viral RNA and DNA itself.
The problem of delivery into the hepatocytes and possible side effects are likely to delay or kill this interesting effort to combat Hepatitis B.
A mix of different RNAis for each message could reduce several components of the virions production as well as the accessory proteins (eAntigen and HBsAg) independently and in a collaborative fashion. The replication is only indirectly affected as much as its components - genomic RNA, core and Polymerase can be reduced, but not the process of building viral RNA and DNA itself.
The problem of delivery into the hepatocytes and possible side effects are likely to delay or kill this interesting effort to combat Hepatitis B.
I will have a go at describing RNAi. It is the designing of a short piece of RNA and delivering it to the inside a cell where it will interfere with gene expression(production of proteins). In the case of HepB, it is designed to interfere with the replication of HBV. So, it is like an antiviral.
Hope I got it right.
Hope I got it right.
Ah of course, I plain forgot about GS9620, Gilead's TLR7 agonist. Yes, Stef2011 had also posted about existing TLR7 products. A Chinese forum reader also commented that it was like another way to inject Interferon.
The vaccine I have in mind was based on Gilead's collaboration with GlobeImmune:
The collaboration with Gilead aims to generate therapeutic vaccine products that have a specific HBV DNA antigens cloned into S. cerevisiae. The firms anticipate that combining a therapeutic vaccine with oral suppressive antiviral therapy will help increase surface antigen (HBsAg) loss with seroconversion. “Based on the proof-of-concept studies in hepatitis C infection, we believe that the combination of GlobeImmune’s Tarmogen immunotherapy products with oral suppressive antiviral therapy will help eliminate the cells harboring the hepatitis B virus, thus increasing seroconversion within a finite period,” remarks David Apelian, M.D., senior vp of R&D, and CMO at GlobeImmune.
The vaccine I have in mind was based on Gilead's collaboration with GlobeImmune:
The collaboration with Gilead aims to generate therapeutic vaccine products that have a specific HBV DNA antigens cloned into S. cerevisiae. The firms anticipate that combining a therapeutic vaccine with oral suppressive antiviral therapy will help increase surface antigen (HBsAg) loss with seroconversion. “Based on the proof-of-concept studies in hepatitis C infection, we believe that the combination of GlobeImmune’s Tarmogen immunotherapy products with oral suppressive antiviral therapy will help eliminate the cells harboring the hepatitis B virus, thus increasing seroconversion within a finite period,” remarks David Apelian, M.D., senior vp of R&D, and CMO at GlobeImmune.
i have read this RNAi, however understand nothing ..! .. Stephencastle .. you said it may take long before we will see the drug ..
is this technology can kill HBsAg or HBVDNA or boost the immune system or just recover the damage on liver caused by hbv .. thank for your effort in this forum to approach to scientific discription into simple words for normal reader ..
is this technology can kill HBsAg or HBVDNA or boost the immune system or just recover the damage on liver caused by hbv .. thank for your effort in this forum to approach to scientific discription into simple words for normal reader ..
When you mention "Gileads therapeutic vaccine" did you mean its TollLike7 receptor agonist drug, that is currently in development or do they indeed also have a therapeutic vaccine in development?
The TL agonist drug was tested in Woodchucks as presented in Orlando last year and showed very impressive Vl reductions of 3 to 4 logs.
I would like to mention that an other TL7 agonist is already approved for skin conditions. Its name is Imiquimod and the brand name. in most countries is "Aldara cream". It is also absorbed from the skin into the systemic circulation and might well have similar or the same effects on HBV supression by stimulation of the Tcell system by reactivating dormant or exhausted Tcells, the standard scenario in chronic HBV.
The TL agonist drug was tested in Woodchucks as presented in Orlando last year and showed very impressive Vl reductions of 3 to 4 logs.
I would like to mention that an other TL7 agonist is already approved for skin conditions. Its name is Imiquimod and the brand name. in most countries is "Aldara cream". It is also absorbed from the skin into the systemic circulation and might well have similar or the same effects on HBV supression by stimulation of the Tcell system by reactivating dormant or exhausted Tcells, the standard scenario in chronic HBV.
Yes, please do. You can ask him:
1. The clinical trial testing stopping of Tenofovir
2. The more potent form of Tenofovir
3. Gilead's therapeutic vaccine
1. The clinical trial testing stopping of Tenofovir
2. The more potent form of Tenofovir
3. Gilead's therapeutic vaccine
Maybe I can ask him about these exciting technologies on my next office visit with him. He did mention that there were a couple of things that he had coming up in his "bag of tricks"
siRNi is a very promising technology with a very wide range of applications including cancer. However, it has many hurdles to overcome. especially delivery and safety issues. I would say we have to wait for a long time before we will see a drug - unless someone makes a break-through.
I think Gish wrote a paper about this (Gish RG, Satishchandran C, Young M, Pachuk C. RNA interference and its potential applications to chronic HBV treatment: results of a Phase I safety and tolerability study. Antivir Ther. 2011;16(4):547-54).) Gish is also involved with Nuron Biotech.
"This unique technology provides Nuron Biotech with the capability to develop a highly efficient vaccine for the treatment and prevention of HBV and HCV by inducing both cellular (T cell) and humoral (B cell, antibody) immune responses to clear disease," said Robert G. Gish, M.D., Chief of Clinical Hepatology and Professor of Clinical Medicine, University of California, San Diego. Dr. Gish is also a member of the Scientific Advisory Board for Nuron Biotech. "HBV and HCV are life-altering and potentially fatal diseases, and this technology may offer a break-through for a new generation of novel therapies and preventative vaccines for patients around the world."
I think Gish wrote a paper about this (Gish RG, Satishchandran C, Young M, Pachuk C. RNA interference and its potential applications to chronic HBV treatment: results of a Phase I safety and tolerability study. Antivir Ther. 2011;16(4):547-54).) Gish is also involved with Nuron Biotech.
"This unique technology provides Nuron Biotech with the capability to develop a highly efficient vaccine for the treatment and prevention of HBV and HCV by inducing both cellular (T cell) and humoral (B cell, antibody) immune responses to clear disease," said Robert G. Gish, M.D., Chief of Clinical Hepatology and Professor of Clinical Medicine, University of California, San Diego. Dr. Gish is also a member of the Scientific Advisory Board for Nuron Biotech. "HBV and HCV are life-altering and potentially fatal diseases, and this technology may offer a break-through for a new generation of novel therapies and preventative vaccines for patients around the world."
Here's the proper press release:
Arrowhead Releases White Paper on Hepatitis B Virus and Potential RNAi Treatment
PASADENA, Calif. — March 7, 2012 — Arrowhead Research Corporation (NASDAQ: ARWR), a nanomedicine company with development programs in RNA therapeutics and obesity, announced today that it has released a white paper describing the health problem posed by the hepatitis B virus (HBV), the substantial unmet need for chronic HBV infected patients, and how Arrowhead’s Dynamic Polyconjugate (DPC) enabled RNAi therapeutic in development could potentially address deficiencies of current treatment options.
“Hepatitis B is a global health problem without effective treatment for a vast number of patients with chronic disease. The World Health Organization estimates that 360 million people, or 5% of the world’s population, suffer from chronic hepatitis B,” said Christopher Anzalone, Ph.D., President and CEO of Arrowhead. “Advances in hepatitis C treatment have drawn considerable attention over the last year, and we see HBV as a similarly high value target. Extensive data from our development programs across multiple in vitro and animal models suggest that we can leverage RNAi and our DPCs to produce a powerful and highly specific candidate to fight HBV.”
HBV infection occurs primarily in hepatocytes and long-term infection causes hepatic inflammation that leads to acute and chronic hepatic dysfunction including acute hepatic failure, cirrhosis, and hepatocellular carcinoma. The DPC delivery platform is being employed for the HBV product candidate, which is supported by multiple studies including demonstration in non-human primates of safe and effective delivery of siRNA to hepatocytes and promising data generated through mouse models of HBV using a DPC formulation.
“The development of a DPC-enabled HBV candidate began under Roche and we are very pleased with the progress that our scientists have made,” said David Lewis, Ph.D., Vice President of Biology and the site head at Arrowhead’s research and development facility in Madison, WI. “We are excited to provide more detail on the DPC platform and the HBV program during upcoming scientific conferences and through future publication in peer-reviewed journals.”
Arrowhead Releases White Paper on Hepatitis B Virus and Potential RNAi Treatment
PASADENA, Calif. — March 7, 2012 — Arrowhead Research Corporation (NASDAQ: ARWR), a nanomedicine company with development programs in RNA therapeutics and obesity, announced today that it has released a white paper describing the health problem posed by the hepatitis B virus (HBV), the substantial unmet need for chronic HBV infected patients, and how Arrowhead’s Dynamic Polyconjugate (DPC) enabled RNAi therapeutic in development could potentially address deficiencies of current treatment options.
“Hepatitis B is a global health problem without effective treatment for a vast number of patients with chronic disease. The World Health Organization estimates that 360 million people, or 5% of the world’s population, suffer from chronic hepatitis B,” said Christopher Anzalone, Ph.D., President and CEO of Arrowhead. “Advances in hepatitis C treatment have drawn considerable attention over the last year, and we see HBV as a similarly high value target. Extensive data from our development programs across multiple in vitro and animal models suggest that we can leverage RNAi and our DPCs to produce a powerful and highly specific candidate to fight HBV.”
HBV infection occurs primarily in hepatocytes and long-term infection causes hepatic inflammation that leads to acute and chronic hepatic dysfunction including acute hepatic failure, cirrhosis, and hepatocellular carcinoma. The DPC delivery platform is being employed for the HBV product candidate, which is supported by multiple studies including demonstration in non-human primates of safe and effective delivery of siRNA to hepatocytes and promising data generated through mouse models of HBV using a DPC formulation.
“The development of a DPC-enabled HBV candidate began under Roche and we are very pleased with the progress that our scientists have made,” said David Lewis, Ph.D., Vice President of Biology and the site head at Arrowhead’s research and development facility in Madison, WI. “We are excited to provide more detail on the DPC platform and the HBV program during upcoming scientific conferences and through future publication in peer-reviewed journals.”
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