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IRVINE, Calif., April 23, 2019 (GLOBE NEWSWIRE) -- 2Ctech, Inc., a privately-held development stage company focused on the application of nanoparticle technologies for the treatment of retinal diseases, announced the initiation of the first-known clinical program to demonstrate the effectiveness and safety of Quantum Dots (QDs) to achieve photovoltaic stimulation of the neural retina for preservation or enhancement of vision in patients with retinal degenerative diseases and, in particular, Retinitis Pigmentosa (RP). In previous pre-clinical and first-in-human trials, a one-time injection of QDs was administered into the vitreous and trial outcomes provided strong evidence of safety and positive indications of meaningful vision enhancement. The next human studies are intended to meet the intent of FDA’s Early Feasibility Study (EFS) program requirements and will be conducted at several US sites.
“Retinitis Pigmentosa is a particularly challenging condition, with the prospect of almost certain vision loss and with no viable therapeutic options,” said Chair-Department of Ophthalmology at University of Colorado, Naresh Mandava, M.D. “As a result of the innovative work performed by Dr. Jeffrey Olson and our team at the Sue Anschutz-Rodgers Eye Center, we will now have the opportunity for this exciting technology to be validated and strengthened by this important clinical study.”
The preparation and implementation of these clinical trials has been enabled by a Series B funding of $8 Million. The initial planning and support for the product development, clinical strategy, and regulatory filings was supported by an initial Series B-1 investment of $4 Million. Additional Series B-2 investments of $4 Million were recently added. Funding is expected to support completion of the pre-clinical and clinical studies under well-defined protocols and to fully demonstrate safety and efficacy in a well-controlled and defined RP population. Prior funding of the Company included approximately $2.5 Million in combined grants and early Series A investments.
2CTech President and CEO, Jim Taylor stated, “We are more than gratified to have reached this point in the development of this unique and high-potential therapeutic approach for what are otherwise debilitating retinal diseases and conditions. The opportunity to provide meaningful benefits for patients afflicted with RP is something that energizes everyone associated with this important program.”
Measurement of vision benefits in patients with inherited retinal diseases (IRDs) has been a significant challenge with respect to clinical trial designs and endpoint measures. As a result, recent guidance by the FDA has encouraged the use of “functional vision” as a primary endpoint. In 2CTech’s trials, mobility courses developed by Ora, Inc. (Andover, MA) will be utilized as one of the key efficacy measures of therapeutic effects.
David A. Hollander, MD, MBA, Ora’s Chief Medical Officer, noted, “We are proud to collaborate with our partners to provide an endpoint for demonstrating clinically meaningful changes in visual function through immersion of patients in a 360-degree visual challenge environment and we are excited to work with 2CTech on their novel application of QD devices for the treatment of RP.”
About Quantum Dots (QDs)
QDs are semiconductor crystalline structures a few nanometers wide which absorb light and generate a dipole electrical field, thereby stimulating the neuronal retina cells. These unique particles act much like small solar cells which produce energy in response to light. 2CTech’s proprietary QD treatment is designed to respond to the visible light naturally reaching the retina, requiring no artificial or applied light source.
The QDs are packaged in a single-use vial and delivered by a standard pars plana injection, the same way that Anti-VEGF treatment is administered. Once in the vitreous, the QDs migrate by diffusion through the retina and are eventually eliminated by normal biological processes. While in the layers of the retina, the particle emissions are intended to result in direct stimulation of the neural retina, creating action potentials that trigger the normal neural pathways to the brain.
About Retinitis Pigmentosa (RP)
Retinitis Pigmentosa is one of the more common inherited retinal diseases, affecting approximately 150,000 people in the USA, and reportedly up to one million globally. There are currently no effective therapeutic options for patients to prevent or slow progressive vision loss. In addition, the large number of genetic mutations associated with RP makes any one gene therapy of only specific benefit for that gene type, while the 2CTech approach is anticipated to have broad applicability, regardless of the underlying genetic defect.
About 2CTech , Inc.
2CTech, Inc. is a privately-held development stage company based in Irvine, CA, focused on the application of nanoparticle technologies for the treatment of retinal diseases. The Company’s first investigational therapeutic agent, Quantum Dot (QD) technology, is intended to deliver a photovoltaic stimulation to the retina in patients with retinal degenerative diseases. To learn more about 2CTech’s proprietary QD treatment, please visit www.2ctechcorp.com.