The IND trial is designed to enrol patients with moderate-to-severe non-healing wounds at different clinical sites across the US
Amnio Technology has received the US Food and Drug Administration (FDA) Investigational New Drug (IND) approval to begin a Phase 2 clinical trial of PalinGen Flow, an amniotic tissue-based product.
The phase 2 multicentre, randomised, controlled clinical trial is expected to evaluate the efficacy of treatment using PalinGen Flow in adults with chronic ulcers due to venous stasis or diabetic etiologies.
The study is planned to enrol patients with moderate-to-severe non-healing wounds at different clinical sites across the US.
Amnio Technology is planning to start trial recruitment and patient enrolment in the coming month, in partnership with a clinical research organisation (CRO) PharPoint Research.
Amnio Technology chief operating officer Larry Macal said: “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.”
PalinGen Flow contains amniotic fluid-derived elements
Amnio Technology is engaged in development and distribution of amniotic tissue allografts. Amniotic tissue has been studied extensively for its regenerative properties.
According to preclinical studies, amniotic tissues may have the potential to reduce inflammation and stimulate tissue repair in humans.
The company said that amniotic fluid, formulated in a unique sequence and combined with micronized amniotic tissue, contains naturally occurring growth factors, cytokines, and several key protein structures.
PalinGen Flow contains amniotic fluid-derived elements including extracellular material and proteins, and micronized amnion membrane, yielding a fluid allograft for subcutaneous injection.
Amnio Technology expects that the Phase 2 study will establish the safety, tolerability, and preliminary effectiveness of its amniotic tissue-based product as a wound care therapeutic.