June 27, 2017 6:18pm
On track for top-line 1 year powered data and potential BLA filing in Q3/18
BLA to the FDA shortly thereafter and, if approved, launching NeoCart in the second half of 2019
Histogenics Corporation (HSGX) completed of patient enrollment of its NeoCart® P3 clinical trial in accordance with the Special Protocol Assessment (SPA) agreement with the FDA.
Novel tissue implant potentially accelerates recovery and reduces pain through proprietary process that replicates the Body’s Ability to Grow Cartilage …
· The randomized P3 clinical trial is designed to evaluate the safety and efficacy in 245 patients, of NeoCart compared to micro-fracture, the current standard of care for the treatment of articular cartilage defects.
· The primary endpoint of the trial is a dual-threshold responder analysis measuring the improvement in the pain and function of each patient treated with NeoCart compared to those treated with micro-fracture one year after treatment.
· The P3 clinical trial design and primary endpoint is based on Histogenics’ 30-patient Phase 2 clinical trial that demonstrated highly statistically significant superiority results of NeoCart compared to micro-fracture at one year.
The Bottom Line: Two-thirds or more of the patients who suffer from knee cartilage injuries remain untreated, due to the variable outcomes and lengthy rehabilitation associated with existing treatments, often leading to debilitating osteoarthritis. Specifically, patients with defects that are smaller than four centimeters in size, which HSGX believes represent the large majority of the market, are less likely to receive surgical treatment in part due to the low satisfaction with and poor outcomes of existing treatments.
HSGX closed down -$0.05 to $1.80 - BUY