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Birinapant HBV Program
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Birinapant HBV Program

MALVERN, Pa., Nov. 5, 2014 (GLOBE NEWSWIRE) -- TetraLogic Pharmaceuticals Corporation (Nasdaq:TLOG), a clinical-stage biopharmaceutical company focused on discovering and developing novel small molecule therapeutics in oncology and infectious diseases, today announced financial results for the third quarter ended September 30, 2014. These results are included in TetraLogic's Quarterly Report on Form 10-Q which has been filed with the Securities and Exchange Commission.

"This year we have advanced all of our clinical programs," said J. Kevin Buchi, President and Chief Executive Officer of TetraLogic. "First, based on in-vivo data indicating clearance of both hepatitis B DNA and surface antigen (HBsAg), we are advancing birinapant into the clinic in the study for the treatment of chronic hepatitis B. Second, in myelodysplastic syndrome (MDS), we were encouraged by the previously announced Phase 1 data and have commenced enrollment in a Phase 2 trial, to further evaluate the activity of birinapant in combination with standard of care azacitidine. Third, enrollment continues in our signal seeking study of birinapant in combination with Amgen's conatumumab, a TRAIL agonist antibody, in ovarian cancer patients. Finally, we are advancing SHAPE, our novel, topical HDAC inhibitor, into a randomized Phase 2 clinical trial to evaluate its activity in early stage cutaneous T-cell lymphoma (CTCL)."

Summary of Key Development Programs, Updates and Anticipated Milestones

Birinapant HBV Program: In a mouse model we have generated data demonstrating that birinapant induces apoptosis in mouse hepatocytes infected with hepatitis B, while sparing normal hepatocytes.  In the mouse model we have seen clearance of HBsAg. We are commencing enrollment in a multiple ascending dose study of birinapant in subjects with chronic hepatitis B in the fourth quarter of 2014.  We currently expect data to be generated around the middle of 2015.  The trial will be conducted in subjects over the age of 18 with hepatitis B who are receiving treatment with either tenofavir or entecavir and who are HBsAg positive.  The trial is expected to enroll approximately 6 cohorts of 8 subjects each, who will receive 4 weekly treatments with either birinapant or placebo in a 3:1 ratio.  The study is being conducted at multiple clinical sites in Australia and New Zealand.  Although predominantly a safety and tolerability study, patients will also be monitored for reductions in hepatitis B surface antigen as an indication of therapeutic activity. On November 10, 2014, TetraLogic will be discussing its HBV program at an investor forum at the American Association for the Study of Liver Diseases Conference.

Birinapant MDS Program:  In May, we announced that, based upon data from our Phase 1b study of birinapant in combination with azacitidine in patients with higher risk MDS who are either relapsed/refractory or naïve to azacitidine, we initiated a randomized Phase 2 clinical trial in first line higher risk patients. While the primary objective of the Phase 1b clinical study was to characterize the safety and tolerability and determine the recommended Phase 2 dose of birinapant when administered in combination with azacitidine, we did observe bone marrow responses in a number of patients who had relapsed or were refractory to azacitidine.  We currently expect interim data from the Phase 2 study in the middle of 2015.

SHAPE CTCL Program: In May, safety and efficacy data from the Phase 1b randomized placebo controlled clinical study of SHAPE, our topical HDAC inhibitor, in Stage IA –IIA Cutaneous T-cell Lymphoma (CTCL) were presented at the annual Society of Investigative Dermatology meeting and at American Society of Clinical Oncology meeting.  We are advancing SHAPE into a randomized Phase 2 clinical trial in early stage CTCL.  We currently expect data around the end of 2015.

Birinapant/conatumumab Program:  Enrollment continues in a signal-seeking study in combination with conatumumab, Amgen's TRAIL agonist antibody, in 3rd line ovarian cancer.  We currently expect data around the end of 2014.
- See more at: http://www.globenewswire.com/news-release/2014/11/05/680302/10106625/en/TetraLogic-Reports-Third-Quarter-Financial-Results-and-Provides-Clinical-Programs-Update.html#sthash.7jcv50lL.dpuf

Source: http://www.globenewswire.com/news-release/2014/11/05/680302/10106625/en/TetraLogic-Reports-Third-Quarter-Financial-Results-and-Provides-Clinical-Programs-Update.html
Avatar_m_tn
This is actually huge news. This is so close to my house, I'd offer to sign up, but I am not sure I want to be part of that first group as I'd hate to experience any major side effects. I'd rather see the first group "try it" and then decide from there based upon their findings and any sides, etc. Plus, they are not necessarily treating you. From the sounds of it, it's either the med *OR* a placebo, so there's not guarantee you get it.
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