NEW YORK, July 15, 2015 /PRNewswire/ --
ACI Association has initiated research coverage on TetraLogic
Pharmaceuticals Corporation (NASDAQ:TLOG). Select highlights from
the internally released reports are being made available to the
general public (included below), with access to the entirety of the
research available to new members.
Today, membership is open to readers on a complementary basis at
the following URL: http://www.aciassociation.com/?c=TLOG
Highlights from our TLOG Report include:
- Preliminary Clinical Trial Data - In a press release
dated June 30, 2015, TetraLogic
Pharmaceuticals Corporation announced preliminary clinical trial
data from the ongoing Phase 2A study of birinapant in combination
with azacitidine. The study was conducted in patients with first
line higher risk myelodysplastic syndromes (MDS), which is a form
of cancer of bone‑marrow stem cells resulting in fewer than normal
mature blood cells in the circulation. The study is being conducted
as a precursor to the ongoing randomized Phase 2B study.
- Administration of Birinapant during the trial -
The Company highlighted that during the study, birinapant was given
to nine patients at 13 mg/m2 twice a week in combination with the
approved dose of azacitidine for three weeks, during a four-week
cycle. The primary assessment of efficacy was the response rate
using the modified International Working Group criteria (Cheson
2006) at the end of cycle four.
- Participation of Patients & Response - The Company
further informed that out of the nine patients who participated in
the study, six completed four cycles of therapy and underwent a
repeat bone marrow assessment. Three patients experienced a
complete response, one patient experienced a bone marrow complete
response, one patient experienced a partial response and underwent
a stem cell transplant and one patient had stable disease. Three
patients discontinued the study prior to receiving four cycles of
treatment. Although the regimen was well tolerated, certain common
side effects such as fatigue, neutropenia and thrombocytopenia were
observed among the patients under trial.
- Forward Statement - Dr. Lesley
Russell, Chief Medical Officer at TetraLogic stated, "While
acknowledging the small number of patients involved in the study,
we find these data encouraging. We plan to conduct an interim
analysis of the ongoing randomized trial around the end of the year
and look forward to reviewing those results."
- Prior Trials on Birinapant - Prior to this, almost over
a year ago, TetraLogic Pharmaceuticals conducted its Phase 1b study
of birinapant in combination with azacitidine in patients with
relapsed/refractory or naïve higher risk MDS, wherein it selected a
dose of 13mg/m2 twice weekly for three weeks out of four to be used
in its Phase 2 clinical trial. The main objective of the Phase 1b
clinical study was to understand the safety and tolerability and
determine the recommended phase 2 dose of birinapant when
administered in combination with azacitidine, besides evaluating
any preliminary indications of efficacy and pharmacodynamics of the
combination.
To find out how this influences our rating on TetraLogic
Pharmaceuticals Corporation, read the full report in its entirety
here: http://www.aciassociation.com/?c=TLOG
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