PHOENIX, Nov. 4, 2020 /PRNewswire/ — 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.
Regulators authorized AstraZeneca’s coronavirus vaccine for use in adults throughout the European Union on Friday, amid criticism the bloc is not moving fast enough to vaccinate its population.
WASHINGTON (AP) — A former FBI lawyer was sentenced to probation for altering an email that the Justice Department relied on during its surveillance of an aide to President Donald Trump during the Russia investigation.
MADISON, Wis. (AP) — Democratic Gov. Tony Evers lashed out Friday at rival Republicans who tried to repeal his statewide mask mandate, saying killing the order would be a ridiculous move comparable to abolishing speed limits.
COLUMBIA, S.C. (AP) — As some conservatives in South Carolina celebrated getting a bill that would ban almost all abortions in the state past a legislative barrier and likely becoming law, they said they are not finished trying to end all abortions.
A Moscow court on Friday put the brother and several allies of Russian opposition leader Alexei Navalny under house arrest for two months as authorities sought to stymie more protests over the jailing of the top Kremlin foe.