The privately held company has submitted a Type IV Drug Master File (DMF) to the US Food and Drug Administration (FDA) for Neowater. This will help Do-Coop's pharmaceutical clients to cross-reference the DMF in their regulatory filings when they want to take Neowater-solvated compounds into clinical trials, the company says. The other milestone is that the first current good manufacturing practice (cGMP)-compliant manufacturing plant for Neowater is up and running in Israel. Together these achievements "mean that our pharma customers can now start clinical studies for their compounds formulated with Neowater, and also avoid the need for a separate Neowater control in their studies", noted Eran Gabbai, founder, president and chief technology officer of Do-Coop, as well as inventor of the Neowater technology. Formed in 1997 and based in Or Yehuda, near Tel Aviv, Do-Coop manufactures and markets synthesised water-based nano-reagents for pharmaceutical, molecular biology and medical diagnostic applications. The Neowater platform can be used to release the value of compounds that have proved effective in vitro but are hampered by poor solubility, over-solubility or a propensity for hydrolysis, it says. In Do-Coop's patented process, inorganic, insoluble crystals are introduced to water, creating nanoparticles with a typical diameter of 5-50nm and a concentration in the range of 1011-1013 nanoparticles per litre, maintaining the liquid property of the water. The nanoparticles are also chemically inert. The multi-layered hydration shells that form around them, as water molecules bind to the nanoparticles in clathrate-like structures, are thick enough to screen out any chemical interaction with the environment or other biomaterials (e.g., DNA, proteins, enzymes) that are dissolved into Neowater. In the manner of non-ionic detergent-derived micelles, this stable system of largely hydrated nanoparticles reduces the entropy of aqueous solutions, Do-Coop explains. The modification of the physical properties of water provides a better micro-environment for interactions, reactions and activation of molecules in a number of biological systems, with applications ranging from research to diagnostics and biopharmaceuticals. Used in conjunction with therapeutics, the company claims, Neowater can enhance effective cell-membrane permeability, increase drug efficacy, solubility, bioavailability and stability, and improve enzyme activity. As a non-toxic, environmentally friendly and inexpensive biomaterial, it can easily be integrated into existing drugs and diagnostic products. Moreover, Neowater's hydrophilic and hydrophobic properties lend themselves to the reduction or replacement of commonly used solvents such as detergents, surfactants, solvents or DMSO, Do-Coop adds. The company has used the Neowater technology to develop a number of products with pharmaceutical and research applications, including solubility, enzyme activity/stability and cellular uptake enhancers. The first line of Neowater based products targeting the molecular diagnostics and research segments of the life sciences industry was launched in 2004. Do-Coop now offers a Solubilization Service to pharmaceutical and biotechnology companies that want to enhance the bioavailability and solubility of new and existing drugs. According to company spokesman Miguel Cizin, Do-Coop has "a few customers including large US pharma and European customers under New Drug Application agreements". There is also increasing interest in Neowater from pharmaceutical customers looking to solve bioavailability, stability and solubilisation problems with their compounds, he added. The DMF and cGMP milestones illustrate the company's willingness to support its pharma clients "with the level of regulatory needs that the industry demands", Cizin commented. Moreover, it shows "that we have customers ready to move into clinical studies". A Type IV DMF, as submitted by Do Coop, is for excipients used in drug formulations, Cizin explained. It covers the Neowater technology and its use in formulating medicines. The company plans to make parallel filings in Europe and Japan "immediately".
