TCT: BIOrest LABR-312 may BLAST through as new anti-inflammatory therapy
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WASHINGTON, D.C.--BIOrest LABR-312, an IV anti-inflammatory drug, reduced the rates of late loss in diabetic patients and those with high counts of monocyte, and exhibited no safety concerns or signs of overall in-stent lumen loss in stenosis patients, according to the results of the late-breaking BLAST trial presented Sept. 24 at the 22nd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific meeting.
Shmuel Banai, MD, of the Tel Aviv Medical Center in Israel, who presented the BLAST (Biorest Liposomal Alendronate with Stenting sTudy) trial, said that the trial enrolled 226 patients to evaluate the use of LABR-312 “to alleviate an issue concerning balloon angioplasty and bare-metal stents (BMS),” both of which are linked to high rates of restenosis.
Banai, called BIOrest LABR-312 a “novel anti-inflammatory drug able to transiently modulate systemic monocyte function following angioplasty in a highly selective manner.”
The hypothesis of the trial was that “modulation of systemic and local inflammation will attenuate intimal hyperplasia after BMS implantation," and trial endpoints included in-stent late loss.
Additionally, during the study the researchers evaluated baseline monocyte counts and evaluated a diabetic subset of patients.
“As for the results, there were no statistical differences between placebo and the treatment groups in major adverse cardiovascular events (MACE), cardiac death, MI or clinically driven target lesion revascularization (TLR),” said Bania. And he said there were “no specific safety concerns” that were linked directly to the study drug.
Banai also noted that while there were no statistical differences reported between the placebo groups or treatment groups as it pertained to efficacy he said, “when we looked at the differential response, patient by patient and group by group, we saw ... very high differences between the treatment group and placebo group [in the distribution curve].”
While Banai noted that the placebo group showed a “normal Gaussian peak” in lumen loss, he said that the rate of late loss for the treatment group was skewed.
“What we get out of here is that response to the therapy was differential and while there were some subgroups of patients who benefited from the treatment other subgroups did not benefit from the treatment.”
While the results showed that there were no differences in the values of late losses at six months, the researchers did find a 27 percent reduction in late loss in diabetic patients and a 33 percent reduction in late loss in patients who had reported high monocyte counts.
“So we conclude that there was no safety concern associated with the study drug.” Additionally, Bania said that “in the total study cohort, LABR-312 had no effect on in-stent late loss, which was the primary endpoint, but in pro-inflammatory patients … there was a statistically significant and clinically meaningful reduction in late loss with the study drug,” Banai concluded.
Banai said that future clinical trials will focus on the clinical effect of LABR-312.
“This differential response would be identified and predicted a-priori providing the potential for personalized medicine.”
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| Slideshow | The Biorest Liposomal Alendronate with Stending Study (BLAST) Trial: Targeted Anti-Inflammatory Systemic Therapy for Restenosis |
| Shumel Banai, MD Tel Aviv Medical Center  |
Shmuel Banai, MD, of the Tel Aviv Medical Center in Israel, who presented the BLAST (Biorest Liposomal Alendronate with Stenting sTudy) trial, said that the trial enrolled 226 patients to evaluate the use of LABR-312 “to alleviate an issue concerning balloon angioplasty and bare-metal stents (BMS),” both of which are linked to high rates of restenosis.
Banai, called BIOrest LABR-312 a “novel anti-inflammatory drug able to transiently modulate systemic monocyte function following angioplasty in a highly selective manner.”
The hypothesis of the trial was that “modulation of systemic and local inflammation will attenuate intimal hyperplasia after BMS implantation," and trial endpoints included in-stent late loss.
Additionally, during the study the researchers evaluated baseline monocyte counts and evaluated a diabetic subset of patients.
“As for the results, there were no statistical differences between placebo and the treatment groups in major adverse cardiovascular events (MACE), cardiac death, MI or clinically driven target lesion revascularization (TLR),” said Bania. And he said there were “no specific safety concerns” that were linked directly to the study drug.
Banai also noted that while there were no statistical differences reported between the placebo groups or treatment groups as it pertained to efficacy he said, “when we looked at the differential response, patient by patient and group by group, we saw ... very high differences between the treatment group and placebo group [in the distribution curve].”
While Banai noted that the placebo group showed a “normal Gaussian peak” in lumen loss, he said that the rate of late loss for the treatment group was skewed.
“What we get out of here is that response to the therapy was differential and while there were some subgroups of patients who benefited from the treatment other subgroups did not benefit from the treatment.”
While the results showed that there were no differences in the values of late losses at six months, the researchers did find a 27 percent reduction in late loss in diabetic patients and a 33 percent reduction in late loss in patients who had reported high monocyte counts.
“So we conclude that there was no safety concern associated with the study drug.” Additionally, Bania said that “in the total study cohort, LABR-312 had no effect on in-stent late loss, which was the primary endpoint, but in pro-inflammatory patients … there was a statistically significant and clinically meaningful reduction in late loss with the study drug,” Banai concluded.
Banai said that future clinical trials will focus on the clinical effect of LABR-312.
“This differential response would be identified and predicted a-priori providing the potential for personalized medicine.”