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Re: drkazmd65 post# 100433

Tuesday, 09/30/2014 11:31:34 PM

Tuesday, September 30, 2014 11:31:34 PM

Post# of 146211
Looks like a large bulk of this year's work is still on the pre-tox studies and manufacturing (test development of the drugs).
From 10K:-

Much of the R&D work this year, other than the programs listed above, was focused on the IND-enabling development of our anti-influenza drug candidate, Injectable FluCide. We have been actively studying different chemical processes and routes of synthesis of the backbone polymer, the ligand, and the nanoviricide drug itself, which is a chemical conjugate of the two. The objective of these studies is to develop pathways that will allow industrial manufacturing scale production of a well-defined drug substance, so that multiple batches will produce consistent product. Our studies also involve the development of methods of chemical and physical characterization of the materials at various stages in the entire production process. These studies also include performing the syntheses at different scales, and at least sufficiently characterizing the products at different stages to enable decision-making regarding different possible process variations. We are also continuing to develop additional tests that are needed for analyses of samples from animals that will be generated during the safety/toxicology studies, and later in the human clinical trials. Such tests are needed for estimating a drug’s distribution pattern in the body as well as the time profile of the distribution. Such tests are also needed to decipher the metabolic fate of the drug. Since a nanoviricide drug is not a simple small chemical or an antibody, development of these tests is relatively complex, and is taking a significant amount of time.

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