Boston, MA 10/02/2014 (wallstreetpr) – Biopharmaceutical company, NanoViricides Inc (NYSEMKT:NNVC) disclosed that it shipped FluCide to BioAnalytical Systems Inc. for the commencement of toxicology trials. The company has selected BioAnalytical to perform safety trials.
IND Submission
NanoViricides Inc (NYSEMKT:NNVC) indicated that the safety and toxicology trials were needed for the submission of Investigational New Drug or IND application; its statement revealed. During the preliminary safety study, the company found that injectable FluCide drug candidate as extremely safe in mice. There was no proof of any unfavorable events even when the dosage was at the maximum tolerable level.
The company said that the trial indicated no changes in every observed parameter even when the dosage was at the maximum possible level of 2,700 mg/kg/d repeatedly given for five straight days. As a result and after consulting BioAnalytical Systems, it has designed the toxicology and safety trials for some starting trials.
NanoViricides expects 2.5 kg of the drug substance needed for the total tox package studies. The company disclosed that it has split the trials into parts and started developing a study protocol requiring only 200g a batch. Concurrently, it has also scaled up its synthesis process under the present Wood Street facilities to produce 200g a batch, which has undergone some tests for the quality. It then prepared the samples based on the protocol design and shipped them to BioAnalytical.
Market Size
NanoViricides Inc (NYSEMKT:NNVC) said that the total market size of injectable FluCide was predicted to be approximately $50 billion. Aside from developing a vaccine, the company indicated that it was also working on five other commercially essential drug candidates. They were: Oral FluCide, HerpeCide, HIVCide, and DengueCide. These were meant to treat out-patients affected by influenzas apart from a wider spectrum of antiviral drug for viral diseases.
NanoViricides said that all its programs were for treating viral infections and expect them to be useful for prophylactics too. The company said it has about $48 million in cash and investments, and this should be enough to take a minimum one or two drug candidate to initial human clinical trials.
