Asana recently conducted a robust multi-arm double-blinded pivotal preclinical study in anticipation of using it to file with regulatory authorities for a first in man clinical study. Management anticipates completion of the final report in Q2/Q3 2016. Results thus far underscore previous results obtained in Asana’s completed animal studies related to proof of concept (see Pilot Rat Study, Preclinical Canine Study).
Preclinical Pilot Rat Study
Six rats were given UC via DSS (a chemically induced inflammation). Three were left untreated and three were given ECMH once/day for seven days, then followed for seven days. All three control animals (no treatment) showed inflammation and no mucosal regrowth. In contrast, all three experimental animals (ECMH) showed reduction in inflammation and mucosal regrowth consistent with healthy controls.
Preclinical Canine Study
A well-controlled pilot animal study conducted as part of the Company’s preclinical studies showed positive results. In order to simulate severe ulcerative colitis, six dogs underwent a surgical mucosectomy of the rectum and ECM was sutured in place in four animals, with the remaining two serving as controls. In the ECM-treated group the tissue was restored to normal based on the anatomy and histology. Further, the results showed no stricture (narrowing) in the affected area. The mucosal layer was not regrown in the untreated control group.
- Six dogs (4 experimental + 2 control), survived 2 to 12 weeks
- Surgical mucosectomy in rectum (all six dogs)
- Engineered tissue ECM sutured in place (four experimental dogs)
- Control dogs: stricture + no mucosal regrowth
- Experimental dogs: no stricture + regrowth of histologically normal mucosa, see below – animals at 8 weeks