Posted in | News | Nanomedicine | Nanobusiness

NanoViricides, Bioanalytical Systems Partner for Drug Development Studies

NanoViricides, Inc. (OTCBB: NNVC) (the "Company") announced today that it has entered into an agreement with Bioanalytical Systems, Inc. (NASDAQ: BASI) to conduct drug development studies required for submission of Investigational New Drug (IND) applications to the FDA for its nanoviricides® drug candidates against various viral diseases.

The Company has designed the toxicology and safety pharmacology studies that will enable the IND submission and the first-in-human clinical trials of its FluCide® investigational anti-influenza product. BASi will conduct the cGLP and non-GLP studies as required (cGLP = current Good Laboratory Practices). These studies are designed to assess overall safety in animals receiving multiple doses of FluCide. Specific safety pharmacology studies will also be conducted to assess the effects of FluCide® on the cardiovascular, respiratory and central nervous systems. These studies are required for US FDA IND submission, as well as for applications to conduct human clinical trials in other countries such as Australia.

The design of the studies was reviewed by the FDA in a pre-IND meeting, as previously announced by the Company.

The Company has previously reported successful results of the Company’s FluCide™ drug candidates in pre-clinical animal studies using two different phylogenetically distinct types of Influenza A, viz. H1N1 and H3N2. The Company has also reported that the drug candidates have been found to be extremely safe in these animal studies. The Company intends to conduct additional efficacy studies as required for the IND application in parallel with the safety/toxicology studies.

The Company anticipates that it will need very large quantities of the drug candidate for these “tox package” studies. The Company has found FluCide to be safe in animals at large dosages, and will need to determine certain safety and toxicology limit parameters. The Company is currently performing scale-up studies in order to produce the necessary quantities of the drug candidate.

Source: http://www.nanoviricides.com

Citations

Please use one of the following formats to cite this article in your essay, paper or report:

  • APA

    NanoViricides, Inc. (2019, February 11). NanoViricides, Bioanalytical Systems Partner for Drug Development Studies. AZoNano. Retrieved on May 19, 2024 from https://www.azonano.com/news.aspx?newsID=25951.

  • MLA

    NanoViricides, Inc. "NanoViricides, Bioanalytical Systems Partner for Drug Development Studies". AZoNano. 19 May 2024. <https://www.azonano.com/news.aspx?newsID=25951>.

  • Chicago

    NanoViricides, Inc. "NanoViricides, Bioanalytical Systems Partner for Drug Development Studies". AZoNano. https://www.azonano.com/news.aspx?newsID=25951. (accessed May 19, 2024).

  • Harvard

    NanoViricides, Inc. 2019. NanoViricides, Bioanalytical Systems Partner for Drug Development Studies. AZoNano, viewed 19 May 2024, https://www.azonano.com/news.aspx?newsID=25951.

Tell Us What You Think

Do you have a review, update or anything you would like to add to this news story?

Leave your feedback
Your comment type
Submit

While we only use edited and approved content for Azthena answers, it may on occasions provide incorrect responses. Please confirm any data provided with the related suppliers or authors. We do not provide medical advice, if you search for medical information you must always consult a medical professional before acting on any information provided.

Your questions, but not your email details will be shared with OpenAI and retained for 30 days in accordance with their privacy principles.

Please do not ask questions that use sensitive or confidential information.

Read the full Terms & Conditions.