Muscle Pain

May 14, 2018

Bonti announced it has initiated dosing in its LANTERN-2 clinical trial, a Phase II clinical trial under Bonti’s LANTERN (Long-Acting NeuroToxin-E Relief, Non-opioid) clinical program aimed at treating focal muscle pain and reducing use of rescue medications, including opioids. LANTERN-2 is a randomized, placebo-controlled, ascending dose, double-blind clinical trial to evaluate the safety and efficacy of intramuscular (IM) injections of Bonti’s therapeutic product candidate, EB-001T, in subjects undergoing elective abdominoplasty (tummy tuck) surgery. The primary endpoint in this trial will be reduction of post-operative pain at rest as measured by the Numeric Pain Rating Scale (NPRS) over the first 96 hours. Secondary endpoints include NPRS during activity and patient use of rescue medications, including opioids, to address unrelieved pain. LANTERN-2 trial was based on favorable safety results from the recently completed LANTERN-1 clinical trial, which was Bonti’s first trial in the LANTERN program. EB-001T showed favorable safety in a wide dose range and was well tolerated, and in which the maximum tolerated dose was not reached.

February 3, 2014

Pluristem Therapeutics released results of a phase I/II trial of PLacental eXpanded (PLXPAD) cells for the treatment of muscle injury. This randomized, placebo-controlled, doubleblinded study enrolled 20 patients randomized into three treatment groups. Each patient received an injection in the gluteal muscle that had been traumatized during surgery. One group was treated with 150 million PLX-PAD cells per dose (n=7), the second was administered 300 million PLX-PAD cells per dose (n=6) and the third received placebo (n=7). The primary efficacy endpoint of the study was the change in maximal voluntary isometric contraction force of the gluteal muscle at six months post-surgery. Efficacy was shown in both PLX-PAD treated patient groups, with the group receiving the 150 million cell dose displaying a statistically significant 500% improvement over the placebo group in the change of the maximal contraction force of the gluteal muscle (p=0.0067). Patients treated at the 300 million cell dose showed a 300% improvement over the placebo (p=0.18).