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.
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Showing posts with label GI-5005. Show all posts
Showing posts with label GI-5005. Show all posts
November 8, 2010
AASLD: Therapeutic HCV Vaccine Opens Door to Potential Treatment Option
Bob Roehr
November 8, 2010 (Boston, Massachusetts) — Proof of concept for the therapeutic vaccine GI-5005 (GlobeImmune) against hepatitis C virus (HCV) infection, used in combination with standard of care (pegylated-interferon alfa-2b plus ribavirin), was presented here at The Liver Meeting 2010: American Association for the Study of Liver Diseases 61st Annual Meeting. Results were presented by Paul J. Pockros, MD, from the Scripps Clinic in San Diego, California.
One novel approach to treating hepatitis C is to stimulate the immune system to better attack and clear the infection, Dr. Pockros explained. This approach contrasts with most interventions currently in development that use small molecules to directly attack the virus.
The vaccine strategy incorporates HCV nonstructural protein 3 (NS3) and core antigens into recombinant Saccharomyces cerevisiae, a family of budding yeast, and expresses those proteins on the surface of the yeast cell. Dr. Pockros said the mechanism of action is not completely clear, but it is thought that subcutaneous injection of the yeast "stimulates a danger signal, which in turn brings antigen-presenting cells like dendritic cells to the surface."
"Those quickly phagocytose the inactivated yeast. The proteins are broken down, and NS3 and core proteins are expressed on the surface of the dendritic cell. This then stimulates helper and killer T cells," which identify and attack hepatocytes infected with hepatitis C.
"If you give this to patients who are chronically infected, it mimics patients who are acutely infected with HCV — they clear the virus," Dr. Pockros explained. Typically, chronically infected patients do not mount a T cell response against the core, envelop, or nonstructural proteins of HCV, whereas patients who clear the virus "mount a modest response against the envelop proteins and a robust response against nonstructural proteins NS3 and NS5," he added.
The phase 2 study was conducted in 133 patients infected with HCV genotype 1 who were randomized in a 1:1 manner to the vaccine or standard of care. Those assigned to active treatment received 40YU GI-5005 monotherapy (1 YU = 107 yeast particles) 5 times a week, then twice monthly during a 12-week lead-in period before adding standard of care (pegylated-interferon alfa-2b plus ribavirin) and reducing the vaccine dosing to once a month. Treatment-naïve patients followed this regimen for 48 weeks, and nonresponders followed it for 72 weeks. The principle end point was end-of-treatment response/sustained viral response (SVR).
Dr. Pockros said that "there was a slight benefit [from the vaccine] in the treatment-naïve and nonresponders; this was numerical only and was not statistically significant. However, when you added the 2 groups together, it became statistically significant" (P = .037).
Stratifying by IL28B gene status in the standard of care group, 2 of 5 patients with the more difficult to treat T/T allele cleared the virus at some point, but 1 subsequently had viral breakthrough while on therapy, and the second relapsed, "so none of the patients had an SVR."
However, "of the T/T patients who received the vaccine, all 5 cleared the virus. Two had to be taken off therapy because of the side effects of [pegylated-interferon alfa-2b plus ribavirin], but the remaining 3 had a sustained virologic response," according to Dr. Pockros.
He said there was only a modest response among those who were previous virologic nonresponders.
There was a statistically significant difference in those whose alanine transaminase (ALT) levels normalized. "Some of these responses were durable, although this did not quite reach significance" in this study, which was underpowered for subset analysis. Biopsy of 32 patients strongly suggests that the normalization of ALTs seen in some patients "is associated with the reduction in necroinflammation."
Perhaps the most interesting response among those who received the vaccine was the T cell, measured by ELISPOT assay. "It mimicked what you saw with a virologic response," Dr. Pockros said. "Four of 5 T/T allele patients had a T cell response; 1 did not actually get treated. But none of the patients who received standard of care had a T cell response." During the discussion, Dr. Pockros said the vaccine is likely to be genotype specific.
Adverse events mirrored those seen with standard of care, with the addition of some modest reactions at the site of injection for the therapeutic vaccine. The product has currently been administered to more than 250 study subjects.
Session cochair Douglas R. LaBrecque, MD, director of liver services at University of Iowa Health Care in Iowa City, told Medscape Medical News that the data "are so preliminary and in such small numbers that all you can say is it wasn't a total failure."
But he does see a benefit to the approach "if it would allow you to eliminate some of the medications [in a regimen], be it the interferon or small molecules, which have their own side effects."
The private biopharmaceutical company GlobeImmune sponsored the trial. Dr. Pockros reports ongoing research ties with the company. Dr. LaBrecque has disclosed no relevant financial relationships.
The Liver Meeting 2010: American Association for the Study of Liver Diseases (AASLD) 61st Annual Meeting: Abstract LB-6. Presented November 1, 2010.
Source
November 8, 2010 (Boston, Massachusetts) — Proof of concept for the therapeutic vaccine GI-5005 (GlobeImmune) against hepatitis C virus (HCV) infection, used in combination with standard of care (pegylated-interferon alfa-2b plus ribavirin), was presented here at The Liver Meeting 2010: American Association for the Study of Liver Diseases 61st Annual Meeting. Results were presented by Paul J. Pockros, MD, from the Scripps Clinic in San Diego, California.
One novel approach to treating hepatitis C is to stimulate the immune system to better attack and clear the infection, Dr. Pockros explained. This approach contrasts with most interventions currently in development that use small molecules to directly attack the virus.
The vaccine strategy incorporates HCV nonstructural protein 3 (NS3) and core antigens into recombinant Saccharomyces cerevisiae, a family of budding yeast, and expresses those proteins on the surface of the yeast cell. Dr. Pockros said the mechanism of action is not completely clear, but it is thought that subcutaneous injection of the yeast "stimulates a danger signal, which in turn brings antigen-presenting cells like dendritic cells to the surface."
"Those quickly phagocytose the inactivated yeast. The proteins are broken down, and NS3 and core proteins are expressed on the surface of the dendritic cell. This then stimulates helper and killer T cells," which identify and attack hepatocytes infected with hepatitis C.
"If you give this to patients who are chronically infected, it mimics patients who are acutely infected with HCV — they clear the virus," Dr. Pockros explained. Typically, chronically infected patients do not mount a T cell response against the core, envelop, or nonstructural proteins of HCV, whereas patients who clear the virus "mount a modest response against the envelop proteins and a robust response against nonstructural proteins NS3 and NS5," he added.
The phase 2 study was conducted in 133 patients infected with HCV genotype 1 who were randomized in a 1:1 manner to the vaccine or standard of care. Those assigned to active treatment received 40YU GI-5005 monotherapy (1 YU = 107 yeast particles) 5 times a week, then twice monthly during a 12-week lead-in period before adding standard of care (pegylated-interferon alfa-2b plus ribavirin) and reducing the vaccine dosing to once a month. Treatment-naïve patients followed this regimen for 48 weeks, and nonresponders followed it for 72 weeks. The principle end point was end-of-treatment response/sustained viral response (SVR).
Dr. Pockros said that "there was a slight benefit [from the vaccine] in the treatment-naïve and nonresponders; this was numerical only and was not statistically significant. However, when you added the 2 groups together, it became statistically significant" (P = .037).
Stratifying by IL28B gene status in the standard of care group, 2 of 5 patients with the more difficult to treat T/T allele cleared the virus at some point, but 1 subsequently had viral breakthrough while on therapy, and the second relapsed, "so none of the patients had an SVR."
However, "of the T/T patients who received the vaccine, all 5 cleared the virus. Two had to be taken off therapy because of the side effects of [pegylated-interferon alfa-2b plus ribavirin], but the remaining 3 had a sustained virologic response," according to Dr. Pockros.
He said there was only a modest response among those who were previous virologic nonresponders.
There was a statistically significant difference in those whose alanine transaminase (ALT) levels normalized. "Some of these responses were durable, although this did not quite reach significance" in this study, which was underpowered for subset analysis. Biopsy of 32 patients strongly suggests that the normalization of ALTs seen in some patients "is associated with the reduction in necroinflammation."
Perhaps the most interesting response among those who received the vaccine was the T cell, measured by ELISPOT assay. "It mimicked what you saw with a virologic response," Dr. Pockros said. "Four of 5 T/T allele patients had a T cell response; 1 did not actually get treated. But none of the patients who received standard of care had a T cell response." During the discussion, Dr. Pockros said the vaccine is likely to be genotype specific.
Adverse events mirrored those seen with standard of care, with the addition of some modest reactions at the site of injection for the therapeutic vaccine. The product has currently been administered to more than 250 study subjects.
Session cochair Douglas R. LaBrecque, MD, director of liver services at University of Iowa Health Care in Iowa City, told Medscape Medical News that the data "are so preliminary and in such small numbers that all you can say is it wasn't a total failure."
But he does see a benefit to the approach "if it would allow you to eliminate some of the medications [in a regimen], be it the interferon or small molecules, which have their own side effects."
The private biopharmaceutical company GlobeImmune sponsored the trial. Dr. Pockros reports ongoing research ties with the company. Dr. LaBrecque has disclosed no relevant financial relationships.
The Liver Meeting 2010: American Association for the Study of Liver Diseases (AASLD) 61st Annual Meeting: Abstract LB-6. Presented November 1, 2010.
Source
November 2, 2010
AASLD: Early Study Shows HCV Vaccine Works
By Michael Smith , North American Correspondent, MedPage Today
Published: November 02, 2010
Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco
BOSTON -- An experimental therapeutic vaccine against hepatitis C improved response rates by 12% compared with standard care in a small clinical trial, a researcher reported here.
The phase II trial included both treatment-naive patients and those who had not responded to previous care with the standard combination of ribavirin and pegylated interferon, according to Paul Pockros, MD, of the Scripps Clinic in La Jolla, Calif.
Results in both subgroups were similar to the overall outcome but did not reach statistical significance compared with standard care, Pockros told a late-breaker session at the annual meeting of the American Association for the Study of Liver Diseases.
But the findings, based on just 133 patients, are enough to justify continued development of the vaccine, Pockros said, including tests to see if it can be effective without the standard hepatitis C treatment regimen, which has difficult side effects.
The vaccine -- dubbed GI-5005 -- is a recombinant, inactivated yeast that expresses hepatitis antigens, Pockros said.
The immune response generated by the vaccine is similar to that seen among patients who are able to clear the virus without medication -- a modest response to the viral envelope proteins and a robust response to the nonstructural proteins NS3 and NS5.
Patients in the study were randomly assigned to get the vaccine or not. Those getting vaccine first had a 12-week run-in, during which they got five weekly doses of GI-5005, delivered subcutaneously then followed by two monthly doses.
They then got the vaccine on a monthly basis, along with the two standard hepatitis C drugs, ribavirin, and pegylated interferon.
The comparison group, including 65 of the 133 participants, got standard care only.
In both groups, treatment-naive patients were treated for 48 weeks, while previous nonresponders got 72 weeks of treatment. The primary endpoint was sustained virologic response, defined as undetectable virus six months after the end of treatment.
The researchers found:
• 58% of treatment-naive patients who got the vaccine had a sustained virologic response, compared with 48% of those getting standard treatment.
• 17% of previous nonresponders had a sustained virologic response if they got the vaccine compared with 5% of those on standard care.
• And overall, the vaccine yielded a 47% response rate, compared with 35% for standard care.
• The first two results did not reach statistical significance, but the last was significant at P=0.037.
Pockros said that no unexpected adverse effects surfaced during the trial; there was a 13% rate of discontinuation in each study arm due to side effects.
The GI-5005 vaccine, he said, is a "novel approach to hepatitis C" that appears to be safe but needs more study.
A "benign" therapeutic vaccine might be advantageous, according to Douglas LaBrecque, MD, of the University of Iowa in Iowa City, Iowa, who was not part of the study but who moderated the session at which the data was presented.
That would be especially true, he told MedPage Today "if you could eliminate some of the other medications, either interferon or the small molecules, which have their own side effects."
But this study was so preliminary and had such small numbers, LaBrecque stressed, that "all you can say is that it wasn't a total failure."
The study was supported by GlobeImmune, of Louisville, Colo. Pockros reported financial links with Genentech, Vertex, Merck, Gilead, Abbott, Pfizer, Phenomix, Tibotec, Pharmasset, 3RT, Novartis, J&J, Achillon, Regulus, GlobeImmune, Debio, Zymogenetics, and Human Genome Sciences.
LaBrecque had no disclosures.
Primary source: American Association for the Study of Liver Diseases
Source reference:
Pockros P, et al "GI-5005 Therapeutic vaccine plus peg-IFN/ribavirin improves sustained virologic response versus peg-IFN/ribavirin in prior non-responders with genotype 1 chronic HCV Infection" AASLD 2010; Abstract LB-6.
Source
Published: November 02, 2010
Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco
BOSTON -- An experimental therapeutic vaccine against hepatitis C improved response rates by 12% compared with standard care in a small clinical trial, a researcher reported here.
The phase II trial included both treatment-naive patients and those who had not responded to previous care with the standard combination of ribavirin and pegylated interferon, according to Paul Pockros, MD, of the Scripps Clinic in La Jolla, Calif.
Results in both subgroups were similar to the overall outcome but did not reach statistical significance compared with standard care, Pockros told a late-breaker session at the annual meeting of the American Association for the Study of Liver Diseases.
But the findings, based on just 133 patients, are enough to justify continued development of the vaccine, Pockros said, including tests to see if it can be effective without the standard hepatitis C treatment regimen, which has difficult side effects.
The vaccine -- dubbed GI-5005 -- is a recombinant, inactivated yeast that expresses hepatitis antigens, Pockros said.
The immune response generated by the vaccine is similar to that seen among patients who are able to clear the virus without medication -- a modest response to the viral envelope proteins and a robust response to the nonstructural proteins NS3 and NS5.
Patients in the study were randomly assigned to get the vaccine or not. Those getting vaccine first had a 12-week run-in, during which they got five weekly doses of GI-5005, delivered subcutaneously then followed by two monthly doses.
They then got the vaccine on a monthly basis, along with the two standard hepatitis C drugs, ribavirin, and pegylated interferon.
The comparison group, including 65 of the 133 participants, got standard care only.
In both groups, treatment-naive patients were treated for 48 weeks, while previous nonresponders got 72 weeks of treatment. The primary endpoint was sustained virologic response, defined as undetectable virus six months after the end of treatment.
The researchers found:
• 58% of treatment-naive patients who got the vaccine had a sustained virologic response, compared with 48% of those getting standard treatment.
• 17% of previous nonresponders had a sustained virologic response if they got the vaccine compared with 5% of those on standard care.
• And overall, the vaccine yielded a 47% response rate, compared with 35% for standard care.
• The first two results did not reach statistical significance, but the last was significant at P=0.037.
Pockros said that no unexpected adverse effects surfaced during the trial; there was a 13% rate of discontinuation in each study arm due to side effects.
The GI-5005 vaccine, he said, is a "novel approach to hepatitis C" that appears to be safe but needs more study.
A "benign" therapeutic vaccine might be advantageous, according to Douglas LaBrecque, MD, of the University of Iowa in Iowa City, Iowa, who was not part of the study but who moderated the session at which the data was presented.
That would be especially true, he told MedPage Today "if you could eliminate some of the other medications, either interferon or the small molecules, which have their own side effects."
But this study was so preliminary and had such small numbers, LaBrecque stressed, that "all you can say is that it wasn't a total failure."
The study was supported by GlobeImmune, of Louisville, Colo. Pockros reported financial links with Genentech, Vertex, Merck, Gilead, Abbott, Pfizer, Phenomix, Tibotec, Pharmasset, 3RT, Novartis, J&J, Achillon, Regulus, GlobeImmune, Debio, Zymogenetics, and Human Genome Sciences.
LaBrecque had no disclosures.
Primary source: American Association for the Study of Liver Diseases
Source reference:
Pockros P, et al "GI-5005 Therapeutic vaccine plus peg-IFN/ribavirin improves sustained virologic response versus peg-IFN/ribavirin in prior non-responders with genotype 1 chronic HCV Infection" AASLD 2010; Abstract LB-6.
Source
October 28, 2010
GlobeImmune Expands GI-5005-02 Phase 2b Trial to Include Additional Treatment Naive IL28B T/T Subjects With Chronic Genotype 1 HCV
By: Marketwire
Oct. 28, 2010 08:00 AM
LOUISVILLE, CO -- (Marketwire) -- 10/28/10 -- GlobeImmune Inc. today announced the expansion of its Phase 2b clinical trial of GI-5005, an investigational Tarmogen product for the treatment of hepatitis C virus (HCV) infection. The Company previously reported data demonstrating a 60% improvement in sustained virologic response (SVR) in chronically infected HCV patients with the hardest-to-treat IL28B T/T genotype when GI-5005 was added to standard of care (SOC) versus SOC alone (60% vs. 0% SVR). The Company plans to enroll 40 additional subjects with the IL28B T/T genotype. Approximately 20% of chronically infected HCV patients have the IL28B T/T genotype, and those patients are least likely to respond to treatment with SOC. Data from the additional 40 subjects will allow for more precise powering of pivotal clinical trials.
"HCV patients with the IL28B T/T genotype have a very poor prognosis with current treatment options," said Timothy C. Rodell, M.D., President and CEO of GlobeImmune. "We believe that GI-5005 addresses a fundamental deficit in patients carrying the T allele of the IL28B gene by augmenting their deficient T cell immune response against HCV. Our phase 2 immunology data indicate that a limited T cell immune response is likely why the current standard of care, which acts primarily by inhibiting viral replication, has limited efficacy in this patient group."
"Patients with the IL28B T/T genotype have the lowest rates of sustained virologic response to today's standard of care and will very likely continue to have lower response rates and a high rate of anti-viral resistance with the addition of a protease inhibitor," said Mitchell L. Shiffman, M.D., Director of The Liver Institute of Virginia. "Preliminary data strongly suggest that GI-5005 enhances the ability of a patient with the IL28B T/T genotype to respond to HCV treatment. This represents the first significant advance in our ability to treat chronic HCV in patients who are genetically less sensitive to interferon. The expansion of the GlobeImmune program to specifically study patients with the IL28B T/T genotype is an important step for successful treatment of these patients in the future."
Additional data from the original 140 subjects enrolled in the trial will be presented this week at 61st Annual Meeting of the American Association for the Study of the Liver (AASLD) in Boston.
Tarmogens are whole, heat-killed recombinant S. cerevisiae yeast that are engineered to express one or more disease-related proteins. GlobeImmune's GI-5005 Tarmogen is a therapeutic vaccine product candidate that contains conserved HCV proteins and is designed to generate an HCV-specific T-cell response.
About GlobeImmune
GlobeImmune Inc. is a private company developing active immunotherapies called Tarmogens for the treatment of cancer and infectious diseases. Tarmogens generate activated killer T cells that are designed to locate and eliminate cancer cells and/or virally-infected cells. The Company's lead product candidate, GI-5005, is a Tarmogen being developed for the treatment of chronic hepatitis C infection (HCV). 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 Web site at http://www.globeimmune.com/.
This news release and the anticipated presentation contain forward-looking statements that involve risks and uncertainties, including statements relating to initiation and progress of the Company's clinical trial programs and the results from the clinical trials. Actual results could differ materially from those projected and the Company cautions readers not to place undue reliance on the forward-looking statements contained in the release and anticipated presentation.
Source
Oct. 28, 2010 08:00 AM
LOUISVILLE, CO -- (Marketwire) -- 10/28/10 -- GlobeImmune Inc. today announced the expansion of its Phase 2b clinical trial of GI-5005, an investigational Tarmogen product for the treatment of hepatitis C virus (HCV) infection. The Company previously reported data demonstrating a 60% improvement in sustained virologic response (SVR) in chronically infected HCV patients with the hardest-to-treat IL28B T/T genotype when GI-5005 was added to standard of care (SOC) versus SOC alone (60% vs. 0% SVR). The Company plans to enroll 40 additional subjects with the IL28B T/T genotype. Approximately 20% of chronically infected HCV patients have the IL28B T/T genotype, and those patients are least likely to respond to treatment with SOC. Data from the additional 40 subjects will allow for more precise powering of pivotal clinical trials.
"HCV patients with the IL28B T/T genotype have a very poor prognosis with current treatment options," said Timothy C. Rodell, M.D., President and CEO of GlobeImmune. "We believe that GI-5005 addresses a fundamental deficit in patients carrying the T allele of the IL28B gene by augmenting their deficient T cell immune response against HCV. Our phase 2 immunology data indicate that a limited T cell immune response is likely why the current standard of care, which acts primarily by inhibiting viral replication, has limited efficacy in this patient group."
"Patients with the IL28B T/T genotype have the lowest rates of sustained virologic response to today's standard of care and will very likely continue to have lower response rates and a high rate of anti-viral resistance with the addition of a protease inhibitor," said Mitchell L. Shiffman, M.D., Director of The Liver Institute of Virginia. "Preliminary data strongly suggest that GI-5005 enhances the ability of a patient with the IL28B T/T genotype to respond to HCV treatment. This represents the first significant advance in our ability to treat chronic HCV in patients who are genetically less sensitive to interferon. The expansion of the GlobeImmune program to specifically study patients with the IL28B T/T genotype is an important step for successful treatment of these patients in the future."
Additional data from the original 140 subjects enrolled in the trial will be presented this week at 61st Annual Meeting of the American Association for the Study of the Liver (AASLD) in Boston.
- Paul J. Pockros, M.D. of Scripps Clinic will deliver an oral presentation of the results from the GI-5005-02 trial in patients previously treated with SOC in a late-breaker session Monday November 1, 2010 at 6 p.m. EDT in the Hynes Auditorium.
- John M. Vierling, M.D. of Baylor College of Medicine will present immune response data in a poster on Tuesday November 2, 2010 Hynes Exhibit Hall C.
Tarmogens are whole, heat-killed recombinant S. cerevisiae yeast that are engineered to express one or more disease-related proteins. GlobeImmune's GI-5005 Tarmogen is a therapeutic vaccine product candidate that contains conserved HCV proteins and is designed to generate an HCV-specific T-cell response.
About GlobeImmune
GlobeImmune Inc. is a private company developing active immunotherapies called Tarmogens for the treatment of cancer and infectious diseases. Tarmogens generate activated killer T cells that are designed to locate and eliminate cancer cells and/or virally-infected cells. The Company's lead product candidate, GI-5005, is a Tarmogen being developed for the treatment of chronic hepatitis C infection (HCV). 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 Web site at http://www.globeimmune.com/.
This news release and the anticipated presentation contain forward-looking statements that involve risks and uncertainties, including statements relating to initiation and progress of the Company's clinical trial programs and the results from the clinical trials. Actual results could differ materially from those projected and the Company cautions readers not to place undue reliance on the forward-looking statements contained in the release and anticipated presentation.
Source
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