Nuron Biotech Expands Portfolio With License of Therapeutic and Prophylactic Hepatitis Vaccine Candidates
EXTON, Pa., Mar 05, 2012 (BUSINESS WIRE) -- Nuron Biotech Inc. today announced it has acquired an exclusive license of technology and product rights relating to Chimigen(R) multi-antigen vaccines from Akshaya Bio Inc., of Edmonton, Alberta, Canada, for the hepatitis B virus (HBV). Nuron Biotech has also acquired an exclusive option to license prophylactic and therapeutic products for the hepatitis C virus (HCV). Currently, no therapeutic vaccine for HBV and no prophylactic vaccine for HCV exist on the market. Financial terms were not disclosed.
"These licenses and options fit incredibly well with Nuron Biotech's strategy of identifying and in-licensing life-saving and life extending product candidates in the areas of vaccines and biologics," said Shankar Musunuri, Ph.D., MBA, Chief Executive Officer of Nuron Biotech. "This chimeric vaccine platform (Chimigen(R) technology), which is used in generating both therapeutic and prophylactic vaccines, is advanced to the point where we can expect to transition our first candidate into a Phase 1 clinical trial in 2013."
"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."
Currently, 380 million people worldwide are infected with chronic HBV, which is not curable by any known therapy. More than 170 million people are infected by HCV, which is one of the leading causes of chronic liver disease, cirrhosis, liver transplantation and hepatocellular carcinoma.
About Chimigen(R) Vaccine Technology
The bifunctional nature of the chimeric multi-antigen vaccine technology represents a unique and direct approach in the therapy of chronic infectious diseases by specifically targeting antigen-presenting cell receptors with the most effective combination of viral antigen(s) and novel antibody tail fragment, the chimeric antigen. This technology offers to induce a balanced cellular as well as humoral immune response to attack chronic hepatitis B virus (HBV) and hepatitis C virus (HCV) and may offer protection from infection.
About Nuron Biotech
Nuron Biotech is developing novel biologics and vaccines for the prevention and treatment of chronic neurodegenerative and infectious diseases. Our team of industry veterans is advancing products to meet unmet medical needs in the areas of multiple sclerosis, Alzheimer's, hepatitis B and hepatitis C for patients across the globe. Our lead drug candidate, NU100 (interferon beta-1b), is a new chemical entity currently in Phase 3 for patients with multiple sclerosis. www.nuronbiotech.com .
SOURCE: Nuron Biotech Inc.
Showing posts with label HCV vaccine. Show all posts
Showing posts with label HCV vaccine. Show all posts
Monday, March 5, 2012
Thursday, March 17, 2011
Inovio Pharmaceutical partner ChronTech starts Phase II trial of Hepatitis C vaccine
ChronTech Pharma AB is using Inovio's new cellular delivery system as a foundation for it's HCV vaccine, ChronVac-C. The phase 1 trial using ChronVac-C was encouraging, with 5 of 6 subjects achieving an SVR from the initial 7 in the trial. They are starting a Phase IIb trial in Sweden, 20 patients will be given the vaccine plus SOC, another group of 12 will be given SOC alone.
BLUE BELL, PA – March 14, 2011 -- Inovio Pharmaceuticals, Inc. (NYSE Amex: INO), a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today that its partner, ChronTech Pharma AB (formerly Tripep AB), has initiated a Phase IIb clinical study of its ChronVac-C® DNA vaccine for hepatitis C virus (HCV), delivered by Inovio’s proprietary electroporation DNA vaccine delivery technology, in combination with standard of care.
In a Phase I clinical trial of ChronVac-C using Inovio’s MedPulser® electroporation device the therapy resulted in a robust increase in T-cell immune responses against HCV and was safe and well-tolerated. Post-study observation of subjects who completed the protocol and then entered into standard of care (SOC) treatment using interferon and ribavirin showed a complete and rapid viral response (four weeks) in 70% of those participants (5 of 7 patients). More significantly, 83% of the participants (5 of 6 patients) who were monitored for an extended period of time, continued to be free of the virus six months after they completed SOC. SOC treatment alone usually results in about 40-50% of patients reaching undetectable virus levels after six months of treatment.
This Phase II follow-on trial is an open-label, single-dose, randomized trial of 32 patients to further explore the effect of the ChronVac-C® DNA vaccine administered by Inovio’s MedPulser® electroporation delivery device. The therapy will be given two times, with four weeks in between, followed by SOC treatment after the final vaccine dose in treatment-naïve chronic HCV infected genotype-1 subjects. This trial will assess the level of immune responses, levels of HCV viral load, and further assess the response to the delivery technology. Twenty patients will receive ChronVac-C® vaccine delivered with Inovio’s electroporation device; the 12-patient comparison group will receive standard-of-care treatment alone. The study has received approval from the Swedish Medical Products Agency and local ethical committee.
“If we can repeat the Phase I results in this phase IIb study there is certainly a possibility that vaccination with ChronVac-C® before drug therapy could become a part of the standard of care therapy for patients with chronic hepatitis C-virus infection. In particular, we hope that vaccination with this novel therapy will result in a considerable shortening of the duration of interferon and ribavirin treatment,” said Anders Vahlne, CEO of ChronTech Pharma AB.
Dr. J. Joseph Kim, Inovio’s president and CEO, said: “We are encouraged by the phase I results showing the improved cure rate in patients who received the HCV vaccine followed by a SOC drug therapy. Any improvement to the HCV standard of care response rates would be well-received by HCV patients and practitioners. We are pleased to collaborate in this advancement of ChronVac-C®, using Inovio’s innovative delivery technology, into Phase II.”
About Hepatitis C Virus
Hepatitis C virus (HCV) infection is the most common chronic blood borne infection in the United States, where approximately 3.5 million persons have been chronically infected. Worldwide, about 300 million people have been infected with HCV. Based on current statistics for hepatitis C, it is estimated that 8,000 to 10,000 people die each year from chronic liver disease caused by this condition. Chronic HCV infection is the leading indication for liver transplants in the United States. Total health costs associated with hepatitis C virus in the U.S. are estimated at more than $15 billion per year. No vaccine for HCV is currently available.
About Inovio’s Electroporation-Based Delivery Technology
Inovio's electroporation-based DNA delivery systems can increase the cellular uptake of an agent by 1,000 times or more. When used to deliver DNA vaccines, Inovio's systems can increase levels of gene expression (i.e. production of the coded protein) and immune responses by 100 times or more compared to plasmid DNA delivered without other delivery enhancements. Inovio has recently reported best-in-class immune responses with DNA vaccines for cervical dysplasias/cancers and HIV. Inovio has also shown the safety and tolerability of its electroporation devices in many hundreds of patients and continues to advance device innovations to further enhance the utility of these devices for mass vaccinations.
BLUE BELL, PA – March 14, 2011 -- Inovio Pharmaceuticals, Inc. (NYSE Amex: INO), a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today that its partner, ChronTech Pharma AB (formerly Tripep AB), has initiated a Phase IIb clinical study of its ChronVac-C® DNA vaccine for hepatitis C virus (HCV), delivered by Inovio’s proprietary electroporation DNA vaccine delivery technology, in combination with standard of care.
In a Phase I clinical trial of ChronVac-C using Inovio’s MedPulser® electroporation device the therapy resulted in a robust increase in T-cell immune responses against HCV and was safe and well-tolerated. Post-study observation of subjects who completed the protocol and then entered into standard of care (SOC) treatment using interferon and ribavirin showed a complete and rapid viral response (four weeks) in 70% of those participants (5 of 7 patients). More significantly, 83% of the participants (5 of 6 patients) who were monitored for an extended period of time, continued to be free of the virus six months after they completed SOC. SOC treatment alone usually results in about 40-50% of patients reaching undetectable virus levels after six months of treatment.
This Phase II follow-on trial is an open-label, single-dose, randomized trial of 32 patients to further explore the effect of the ChronVac-C® DNA vaccine administered by Inovio’s MedPulser® electroporation delivery device. The therapy will be given two times, with four weeks in between, followed by SOC treatment after the final vaccine dose in treatment-naïve chronic HCV infected genotype-1 subjects. This trial will assess the level of immune responses, levels of HCV viral load, and further assess the response to the delivery technology. Twenty patients will receive ChronVac-C® vaccine delivered with Inovio’s electroporation device; the 12-patient comparison group will receive standard-of-care treatment alone. The study has received approval from the Swedish Medical Products Agency and local ethical committee.
“If we can repeat the Phase I results in this phase IIb study there is certainly a possibility that vaccination with ChronVac-C® before drug therapy could become a part of the standard of care therapy for patients with chronic hepatitis C-virus infection. In particular, we hope that vaccination with this novel therapy will result in a considerable shortening of the duration of interferon and ribavirin treatment,” said Anders Vahlne, CEO of ChronTech Pharma AB.
Dr. J. Joseph Kim, Inovio’s president and CEO, said: “We are encouraged by the phase I results showing the improved cure rate in patients who received the HCV vaccine followed by a SOC drug therapy. Any improvement to the HCV standard of care response rates would be well-received by HCV patients and practitioners. We are pleased to collaborate in this advancement of ChronVac-C®, using Inovio’s innovative delivery technology, into Phase II.”
About Hepatitis C Virus
Hepatitis C virus (HCV) infection is the most common chronic blood borne infection in the United States, where approximately 3.5 million persons have been chronically infected. Worldwide, about 300 million people have been infected with HCV. Based on current statistics for hepatitis C, it is estimated that 8,000 to 10,000 people die each year from chronic liver disease caused by this condition. Chronic HCV infection is the leading indication for liver transplants in the United States. Total health costs associated with hepatitis C virus in the U.S. are estimated at more than $15 billion per year. No vaccine for HCV is currently available.
About Inovio’s Electroporation-Based Delivery Technology
Inovio's electroporation-based DNA delivery systems can increase the cellular uptake of an agent by 1,000 times or more. When used to deliver DNA vaccines, Inovio's systems can increase levels of gene expression (i.e. production of the coded protein) and immune responses by 100 times or more compared to plasmid DNA delivered without other delivery enhancements. Inovio has recently reported best-in-class immune responses with DNA vaccines for cervical dysplasias/cancers and HIV. Inovio has also shown the safety and tolerability of its electroporation devices in many hundreds of patients and continues to advance device innovations to further enhance the utility of these devices for mass vaccinations.
Wednesday, December 1, 2010
Further info on the GI-5005 HCV vaccine study presented at AASLD... hope for those with the IL28 T/T allele?
Synopsis of the GI-5005 study presented at AASLD 2010. Overall, the numbers for GI-5005 aren't extraordinary, but certainly worth further studies. The true benefit for this vaccine may be how it appears to illicit a T-cell response in patients carrying the T allele of the IL28 gene, which didn't occur when the same patients were given standard of care
By: DIANA MAHONEY, Internal Medicine News Digital Network
12/01/10
BOSTON – A therapeutic vaccine against the hepatitis C virus was associated with a significantly higher sustained virologic response rate when added to standard-of-care treatment, and the findings justify further development of the vaccine, Dr. Paul Pockros reported at the annual meeting of the American Association for the Study of Liver Diseases.
In the proof-of-concept trial, 133 patients infected with hepatitis C virus (HCV) genotype 1 were randomized to either triple therapy comprising the experimental GI-5005 vaccine, which is designed to elicit a T-cell response specific to HCV, along with pegylated interferon alfa-2b plus ribavirin (P/R), or the standard P/R therapy alone.
The primary outcome measure was sustained virologic response (SVR), defined as undetectable HCV RNA at 6 months after treatment, said Dr. Pockros of the Scripps Clinic in La Jolla, Calif.
The 68 patients in the experimental group initially received monotherapy with the vaccine, consisting of five weekly injections followed by two monthly injections for a 12-week lead-in period, before progressing to the standard-of-care P/R treatment and once-monthly injections. The 65 patients in the control group received standard-of-care P/R treatment alone.
In both groups, the treatment duration was 48 weeks for treatment-naive patients and 72 weeks for those who had a poor or partial response to prior P/R treatment, said Dr. Pockros. Patients in whom prior P/R therapy induced no notable decrease in HCV viral load, as well as those in whom prior treatment initially resulted in undetectable HCV RNA followed by a viral rebound, were excluded from the analysis.
Among the study’s treatment-naive patients, 58% of those who received the vaccine achieved SVR, compared with 48% of those who received P/R alone. Among the prior poor and partial responders, the respective SVR rates in the vaccine and control groups were 17% and 5%, Dr. Pockros reported.
"There was a slight benefit in the treatment-naive and nonresponders, [but] this was numerical only and was not statistically significant," he said. However, the overall benefit in the vaccine vs. control groups was statistically significant, with respective SVR rates of 47% and 35%, he noted.
The vaccine strategy appears to be safe. "The most common associated adverse events were mild, transient injection-site reactions," said Dr. Pockros. Additionally, he stated, "the discontinuation rates due to adverse events were comparable [13%] in both the triple-therapy and standard-of-care arms."
Of particular interest, Dr. Pockros noted, was the T-cell response in a subgroup of difficult-to-treat patients receiving the vaccine. Previous studies have suggested that patients carrying the T allele of the IL28 gene are at high risk of treatment failure with the standard interferon-based therapy. The T-cell response in vaccine-treated patients, as measured by interferon-gamma enzyme-linked ImmunoSpot assay, "mimicked what we saw with a virologic response," he said.
"Four of five T/T allele patients had a T-cell response – one did not actually get treated – but none of the patients who received standard of care had a T-cell response."
This finding is consistent with the hypothesis that the GI-5005 vaccine corrects a fundamental deficit in cellular immunity in IL28B T/T genotype patients, he said. Although the findings need to be confirmed in additional studies with larger patient populations, the vaccine will likely be genotype specific, he noted.
Because the immune response is similar to that observed in HCV-infected patients who are able to clear the virus without treatment, future studies will evaluate the efficacy of monotherapy with the vaccine in genotype-specific patients, Dr. Pockros said.
The proof-of-concept study was funded by GlobeImmune, manufacturer of the vaccine. Dr. Pockros disclosed financial relationships with GlobeImmune, Genentech, Vertex, Merck, Gilead, Abbott, Pfizer, Phenomix, Tibotec, Pharmasset, 3RT, Novartis, Johnson & Johnson, Achillon, Regulus, Debio, Zymogenetics, and Human Genome Sciences.
By: DIANA MAHONEY, Internal Medicine News Digital Network
12/01/10
BOSTON – A therapeutic vaccine against the hepatitis C virus was associated with a significantly higher sustained virologic response rate when added to standard-of-care treatment, and the findings justify further development of the vaccine, Dr. Paul Pockros reported at the annual meeting of the American Association for the Study of Liver Diseases.
In the proof-of-concept trial, 133 patients infected with hepatitis C virus (HCV) genotype 1 were randomized to either triple therapy comprising the experimental GI-5005 vaccine, which is designed to elicit a T-cell response specific to HCV, along with pegylated interferon alfa-2b plus ribavirin (P/R), or the standard P/R therapy alone.
The primary outcome measure was sustained virologic response (SVR), defined as undetectable HCV RNA at 6 months after treatment, said Dr. Pockros of the Scripps Clinic in La Jolla, Calif.
The 68 patients in the experimental group initially received monotherapy with the vaccine, consisting of five weekly injections followed by two monthly injections for a 12-week lead-in period, before progressing to the standard-of-care P/R treatment and once-monthly injections. The 65 patients in the control group received standard-of-care P/R treatment alone.
In both groups, the treatment duration was 48 weeks for treatment-naive patients and 72 weeks for those who had a poor or partial response to prior P/R treatment, said Dr. Pockros. Patients in whom prior P/R therapy induced no notable decrease in HCV viral load, as well as those in whom prior treatment initially resulted in undetectable HCV RNA followed by a viral rebound, were excluded from the analysis.
Among the study’s treatment-naive patients, 58% of those who received the vaccine achieved SVR, compared with 48% of those who received P/R alone. Among the prior poor and partial responders, the respective SVR rates in the vaccine and control groups were 17% and 5%, Dr. Pockros reported.
"There was a slight benefit in the treatment-naive and nonresponders, [but] this was numerical only and was not statistically significant," he said. However, the overall benefit in the vaccine vs. control groups was statistically significant, with respective SVR rates of 47% and 35%, he noted.
The vaccine strategy appears to be safe. "The most common associated adverse events were mild, transient injection-site reactions," said Dr. Pockros. Additionally, he stated, "the discontinuation rates due to adverse events were comparable [13%] in both the triple-therapy and standard-of-care arms."
Of particular interest, Dr. Pockros noted, was the T-cell response in a subgroup of difficult-to-treat patients receiving the vaccine. Previous studies have suggested that patients carrying the T allele of the IL28 gene are at high risk of treatment failure with the standard interferon-based therapy. The T-cell response in vaccine-treated patients, as measured by interferon-gamma enzyme-linked ImmunoSpot assay, "mimicked what we saw with a virologic response," he said.
"Four of five T/T allele patients had a T-cell response – one did not actually get treated – but none of the patients who received standard of care had a T-cell response."
This finding is consistent with the hypothesis that the GI-5005 vaccine corrects a fundamental deficit in cellular immunity in IL28B T/T genotype patients, he said. Although the findings need to be confirmed in additional studies with larger patient populations, the vaccine will likely be genotype specific, he noted.
Because the immune response is similar to that observed in HCV-infected patients who are able to clear the virus without treatment, future studies will evaluate the efficacy of monotherapy with the vaccine in genotype-specific patients, Dr. Pockros said.
The proof-of-concept study was funded by GlobeImmune, manufacturer of the vaccine. Dr. Pockros disclosed financial relationships with GlobeImmune, Genentech, Vertex, Merck, Gilead, Abbott, Pfizer, Phenomix, Tibotec, Pharmasset, 3RT, Novartis, Johnson & Johnson, Achillon, Regulus, Debio, Zymogenetics, and Human Genome Sciences.
Saturday, November 6, 2010
GlobeImmune's GI-5005 HCV Therapeutic Vaccine increases SVR by 12% in previous treatment failures
By Liz Jones Hollis (http://www.fiercebiotech.com/node/93538/print)
Created Nov 4 2010 - 6:56am
Phase 2b Study Demonstrates GlobeImmune's GI-5005 HCV Therapeutic Vaccine Increases Sustained Virologic Response by 12 Percent in Patients Who Previously Failed Therapy with Standard of Care.
Additional data suggest that cellular immunity may be a fundamental deficit in hardest-to-treat IL28B T/T genotype patients and is corrected by GI-5005
Data to be presented at annual meeting of the American Association for the Study of the Liver Diseases
LOUISVILLE, Colo., October 30, 2010 - GlobeImmune Inc. today announced additional data from the GI-5005-02 Phase 2b study demonstrating that GI-5005, the Company's investigational Tarmogen® product, improved sustained virologic response (SVR) by 12% in patients with genotype 1 chronic hepatitis C virus (HCV) infection who had failed prior treatment with standard of care (SOC, pegylated-interferon alpha 2a plus ribavirin). This study suggests that GI-5005 may have the potential to be the first successful therapeutic vaccine for patients chronically infected with HCV.
Paul J. Pockros, M.D., of Scripps Clinic will deliver the oral presentation of the results in a late-breaker session at 6 p.m. EDT Monday November 1, 2010 at the 61st Annual Meeting of the American Association for the Study of the Liver Diseases (AASLD) in Boston.
On an intent-to-treat basis (subjects who received at least one dose of combination therapy), prior non-responders receiving GI-5005 plus SOC as a triple therapy had an SVR rate of 17%, compared to an SVR rate of only 5% in patients receiving SOC alone. Prior non-responders in this study were defined as patients who did not clear virus after a minimum of 12 weeks of SOC, including null responders, poor responders, and partial responders. Relapsers and on-treatment breakthroughs were not enrolled in the study. The most common adverse events associated with GI-5005 were injection site reactions that were generally mild and transient in nature. Discontinuation rates due to adverse events in the GI-5005 triple therapy arm were comparable to the discontinuation rates in the SOC alone arm.
"Only 4-7% of patients with genotype 1 HCV who were null, poor or partial responders to their first course of pegylated interferon-based therapy would be expected to achieve a sustained virologic response with a second course of treatment," said Dr. Pockros. "In this study, GI-5005 conferred a three-fold improvement in SVR, an important treatment effect in this challenging patient population."
Additional immunology data from the study will be presented in a poster on Tuesday November 2, 2010 by John M. Vierling, M.D., of Baylor College of Medicine. These data show that GI-5005 improved HCV-specific T cell responses 10-fold over SOC alone in patients with the IL28B T/T genotype (~20% of chronically infected patients), the subgroup most likely to fail treatment with SOC alone. Patients with the IL28B T/T genotype receiving SOC alone had an HCV-specific cellular immune response that was 17-fold lower than patients in the IL28B C/C or C/T subgroups. The improved HCV-specific T cell immunity in IL28B T/T patients receiving GI-5005 plus SOC correlates with previously reported data that demonstrated GI-5005 increased SVR rates by 60 percent in interferon-naïve T/T patients compared to T/T patients receiving SOC alone.
"These data suggest that the fundamental deficit in patients carrying the T allele of the IL28B gene is a deficit in adaptive cellular immunity, the mechanism that GI-5005 was designed to address," said David Apelian, M.D., Ph.D., Chief Medical Officer at GlobeImmune. "We are confident that GI-5005 will become a cornerstone of HCV therapy, particularly for difficult to treat populations, such as IL28B T/T patients."
A 40 patient expansion of this study in patients having the IL28B T/T genotype was initiated last week to further explore the potential treatment effect of GI-5005 in this patient population.
GI-5005 is a therapeutic vaccine candidate designed to generate HCV-specific T-cell responses and improve virologic responses in patients with chronic hepatitis C virus infection.
About GlobeImmune
GlobeImmune Inc. is a private company developing therapeutic vaccines called Tarmogens for the treatment of cancer and infectious diseases. Tarmogens generate activated killer T cells that are designed to locate and eliminate virally-infected cells and/or cancer cells. The Company's lead product candidate, GI-5005, is a Tarmogen being developed for the treatment of chronic hepatitis C virus (HCV) infection. GI-5005 is designed to complement both the current standard of care and emerging novel therapies for HCV. The Company's lead oncology program, GI-4000, targets cancers caused by mutated versions of the Ras oncoprotein. GI-4000 is being investigated in clinical trials for the treatment of pancreas cancer as well as other cancers that contain mutated Ras, including non-small cell lung cancer and colorectal cancer. In May 2009, the Company announced a global partnership with Celgene focused on the discovery, development and commercialization of multiple product candidates for the treatment of cancer.
For additional information, please visit the company's website at www.globeimmune.com.
Created Nov 4 2010 - 6:56am
Phase 2b Study Demonstrates GlobeImmune's GI-5005 HCV Therapeutic Vaccine Increases Sustained Virologic Response by 12 Percent in Patients Who Previously Failed Therapy with Standard of Care.
Additional data suggest that cellular immunity may be a fundamental deficit in hardest-to-treat IL28B T/T genotype patients and is corrected by GI-5005
Data to be presented at annual meeting of the American Association for the Study of the Liver Diseases
LOUISVILLE, Colo., October 30, 2010 - GlobeImmune Inc. today announced additional data from the GI-5005-02 Phase 2b study demonstrating that GI-5005, the Company's investigational Tarmogen® product, improved sustained virologic response (SVR) by 12% in patients with genotype 1 chronic hepatitis C virus (HCV) infection who had failed prior treatment with standard of care (SOC, pegylated-interferon alpha 2a plus ribavirin). This study suggests that GI-5005 may have the potential to be the first successful therapeutic vaccine for patients chronically infected with HCV.
Paul J. Pockros, M.D., of Scripps Clinic will deliver the oral presentation of the results in a late-breaker session at 6 p.m. EDT Monday November 1, 2010 at the 61st Annual Meeting of the American Association for the Study of the Liver Diseases (AASLD) in Boston.
On an intent-to-treat basis (subjects who received at least one dose of combination therapy), prior non-responders receiving GI-5005 plus SOC as a triple therapy had an SVR rate of 17%, compared to an SVR rate of only 5% in patients receiving SOC alone. Prior non-responders in this study were defined as patients who did not clear virus after a minimum of 12 weeks of SOC, including null responders, poor responders, and partial responders. Relapsers and on-treatment breakthroughs were not enrolled in the study. The most common adverse events associated with GI-5005 were injection site reactions that were generally mild and transient in nature. Discontinuation rates due to adverse events in the GI-5005 triple therapy arm were comparable to the discontinuation rates in the SOC alone arm.
"Only 4-7% of patients with genotype 1 HCV who were null, poor or partial responders to their first course of pegylated interferon-based therapy would be expected to achieve a sustained virologic response with a second course of treatment," said Dr. Pockros. "In this study, GI-5005 conferred a three-fold improvement in SVR, an important treatment effect in this challenging patient population."
Additional immunology data from the study will be presented in a poster on Tuesday November 2, 2010 by John M. Vierling, M.D., of Baylor College of Medicine. These data show that GI-5005 improved HCV-specific T cell responses 10-fold over SOC alone in patients with the IL28B T/T genotype (~20% of chronically infected patients), the subgroup most likely to fail treatment with SOC alone. Patients with the IL28B T/T genotype receiving SOC alone had an HCV-specific cellular immune response that was 17-fold lower than patients in the IL28B C/C or C/T subgroups. The improved HCV-specific T cell immunity in IL28B T/T patients receiving GI-5005 plus SOC correlates with previously reported data that demonstrated GI-5005 increased SVR rates by 60 percent in interferon-naïve T/T patients compared to T/T patients receiving SOC alone.
"These data suggest that the fundamental deficit in patients carrying the T allele of the IL28B gene is a deficit in adaptive cellular immunity, the mechanism that GI-5005 was designed to address," said David Apelian, M.D., Ph.D., Chief Medical Officer at GlobeImmune. "We are confident that GI-5005 will become a cornerstone of HCV therapy, particularly for difficult to treat populations, such as IL28B T/T patients."
A 40 patient expansion of this study in patients having the IL28B T/T genotype was initiated last week to further explore the potential treatment effect of GI-5005 in this patient population.
GI-5005 is a therapeutic vaccine candidate designed to generate HCV-specific T-cell responses and improve virologic responses in patients with chronic hepatitis C virus infection.
About GlobeImmune
GlobeImmune Inc. is a private company developing therapeutic vaccines called Tarmogens for the treatment of cancer and infectious diseases. Tarmogens generate activated killer T cells that are designed to locate and eliminate virally-infected cells and/or cancer cells. The Company's lead product candidate, GI-5005, is a Tarmogen being developed for the treatment of chronic hepatitis C virus (HCV) infection. GI-5005 is designed to complement both the current standard of care and emerging novel therapies for HCV. The Company's lead oncology program, GI-4000, targets cancers caused by mutated versions of the Ras oncoprotein. GI-4000 is being investigated in clinical trials for the treatment of pancreas cancer as well as other cancers that contain mutated Ras, including non-small cell lung cancer and colorectal cancer. In May 2009, the Company announced a global partnership with Celgene focused on the discovery, development and commercialization of multiple product candidates for the treatment of cancer.
For additional information, please visit the company's website at www.globeimmune.com.
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