Phoenix, October 20, 2020 Amnio Technology, LLC, a global leader in the development and distribution of amniotic tissue allografts, is announcing today that it has received authorization from FDA to proceed with a Phase 2 clinical trial under an Investigational New Drug (IND) application for its amniotic tissue-based product, PalinGen® Flow. The prospective, multicenter, randomized, controlled clinical study will investigate the efficacy of PalinGen® Flow treatment in adults with chronic ulcers of the lower extremities due to venous stasis or diabetic etiologies. PalinGen® Flow is comprised of amniotic fluid-derived elements including extracellular material and proteins, and micronized amnion membrane, yielding a fluid allograft for subcutaneous injection. Amnio Technology has confidence that this Phase 2 trial will demonstrate the safety, tolerability, and preliminary effectiveness of PalinGen® Flow as a wound care therapeutic.
Amniotic fluid, formulated in a proprietary sequence and combined with micronized amniotic tissue contains naturally occurring growth factors, cytokines, and several key protein structures. Amniotic tissue has been studied extensively for its regenerative properties. Preclinical studies suggest that amniotic tissues may have the ability to reduce inflammation and stimulate tissue repair in humans.
Larry Macal, Chief Operating Officer of Amnio Technology, confirms, “We are pleased the FDA has approved Amnio Technology to proceed with our PalinGen® Flow study in the treatment of severe chronic ulcers of the lower extremities due to venous stasis or diabetic etiologies.”
The PalinGen® Flow study will enroll patients with moderate-to-severe non-healing wounds at multiple clinical sites across the U.S. Amnio Technology in partnership with PharPoint Research, an award-winning clinical research organization, expects to commence trial recruitment and subject enrollment in the next 30 days.