NanoViricides Inc. (NNVC)

[changes_iv]

...NanoViricides, Inc.'s achievements this past year was, receiving orphan drug designation from the European Union and the US FDA for DengueCide, their drug for Dengue Hemorrhagic Fever, and Dengue. Also starting construction of their high tech, state of the art nano-medicine anti-viral drug manufacturing plant, the only one in the US and possibly the entire world. Next year's plans include: finishing the plant, completing toxicology studies and submitting paperwork to FDA, while awaiting for permission to start human trials.

source: http://www.marketwired.com/press-release/recap-nanoviricides-inc-ceo-dr-eugene-seymour-clear-channel-business-talk-radio-interview-nyse-mkt-nnvc-1865069.htm

Finishing the plant:

NanoViricides, Inc. has assembled a marquee team of experienced personnel to help us with the design, architecture, and engineering of this facility. Mr. Andrew Hahn continues to provide overall stewardship for this project. He was formerly Senior Director of Engineering, Pharmaceutical Facilities, Global Engineering, at the Bristol-Myers-Squibb Company Worldwide Medicines Group (BMS). He has almost 30 years of experience in architecture, design and project management in the creation of new and refurbished facilities at Bristol-Myers Squibb Company. Mr. Phil Mader and his firm, MPH Engineering, LLC (“MPH”), continue to help with the overall project management and design engineering of the laboratory and cGMP pilot production facility. Prior to founding MPH, from 2000 to 2007, Phil Mader served as the Senior Capital Project Manager at Bristol-Myers Squibb Company in Wallingford, CT (“BMS”). He was involved in the design, implementation, and commissioning of various biology and chemistry laboratory projects within budget and in a timely manner. Ms. Kathyann Cowles of ID3A, LLC, serves as the Principal Architect. Ms. Cowles, co-founder of Id3A, has over thirty years of experience as a licensed Architect and Senior Project Manager for diverse and complex design and construction projects in the academic, science, technology, corporate and research sectors.

Completing toxicology studies:

November 13, 2012 07:00 AM Eastern Standard Time

WEST HAVEN, Conn.--(BUSINESS WIRE)--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.

Submitting paperwork to FDA:

NanoViricides Inc., a development stage company focused on creating special purpose nanomaterials for viral therapy, today announced its consulting agreement with Biologics Consulting Group Inc. (BCG), in which the two companies will prepare for submission of Investigational New Drug (IND) applications to the U.S. FDA for NanoViricides’ nanoviricides® drug candidates.

BCG is an international consulting firm providing national and international regulatory and product development assistance for the development and commercial production of drug, biological and device products.

NanoViricides noted the advances and efforts it has made to get its anti-influenza drug candidates to the pre-IND and IND stages. From here on out, the company has engaged BCG to facilitate the FDA review and approval process, as well as to advise the company on the pre-IND application and development activities to follow.NanoViricides previously reported success in its FluCide™ drug candidates in pre-clinical animal studies, and the company says it remains on track to develop FluCide®.

Awaiting for permission to start human trials:

WEST HAVEN, Conn.--(BUSINESS WIRE)--Jul 23, 2012 - NanoViricides, Inc. (OTC BB: NNVC) (the "Company") announced today that it has retained Australian Biologics Pty. Ltd., a regulatory affairs consulting firm, to coordinate the regulatory review and approval to conduct the first human trials in Australia for Flucide™, the Company's broad-spectrum anti-influenza drug. Australian Biologics will also facilitate clinical trial site(s) selection and development of the clinical trials agreements.

Dr. Jim Ackland, the Manager of Australian Biologics Pty, Ltd, has extensive experience in this field. Prior to becoming managing director of this company, he was Vice-President, West Coast and Asia Pacific operations for the Biologics Consulting Group, the Company's US FDA regulatory affairs consulting group. In the 1990's, he was the Head of Regulatory Affairs, Vaccines, for the CSL Group in Australia. The CSL Group is a global, specialty biopharmaceutical company that researches, develops, manufactures and markets products to treat and prevent serious human medical conditions.

“We are very pleased to engage Jim and his staff because of their extensive experience in both the regulatory and operational aspects of the clinical trials landscape in Australia,” stated Eugene Seymour, MD, MPH, Chief Executive Officer of the Company.
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The events leading to a KaBOOM are in the "good hands" of NanoViricides, Inc. and a marquee team of experienced companies!
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* non-GLP studies were conducted by KARD Scientific, Inc. in Massachusetts

** and control program to enable large scale synthesis of FluCide in a reproducible manner.