Replies to post #115406 on NanoViricides Inc. (NNVC)

[WorstLuck]

no biotech other than NNVC talks seriously about phase 1 and phase 2 tox studies.

An obfuscatory tactic. NNVC has that as a strong point. If you want to call it that.

[changes_iv]

Opinion of an anonymous poster. What can I say,...weak? Just because other companies don't divide Safety/Tox Studies/GLP in phases does not mean it cannot be done? or do you have evidence to the contrary?

Here are the facts:

NanoViricides Retains a Consulting Firm to Expedite First FluCide™ Human Trials in Australia
.
.
.
NanoViricides, Inc. (OTC BB:) (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.

The Company believes that it will have the capability for producing drugs suitable for human clinical trials when renovation of the new facility in Shelton is completed. In parallel, the Company continues to pursue appropriate human clinical study pathways for its highly effective anti-influenza drug candidate, NV-INF-1, in the FluCide™ program. The Company has engaged Australian Biologics to study and develop a roadmap for conducting certain Phase 1 and Phase 2 human clinical studies in Australia.

NV-INF-1 has been shown to be highly effective in controlling influenza viral infection in lethal infection mouse model. Animals survived for full duration of the study (21 days) when treated with NV-INF-1 on alternate days. In contrast, oseltamivir-treated animals (40mg/kg given every day) survived for only 8 days. Untreated animals survive only 5 days in this highly lethal influenza infection model. The Company has previously reported that depending upon the treatment protocol, NV-INF-1 has shown viral load reduction of 1.3 logs to 3 logs in these various studies. In contrast, oseltamivir (Tamiflu®) treatment in the same studies has resulted in viral load reductions of only about 0.2 logs to 0.8 logs. Further, the lung damage caused by the influenza virus infection is also substantially reduced upon FluCide treatment as compared to oseltamivir treatment. Our data indicate that NV-INF-1 is significantly more effective compared to the standard-of-care drug for influenza, viz. oseltamivir.

The Company believes, based on our animal studies data, that NV-INF-1 may be the most effective anti-influenza drug currently in development.

is a development stage company that is creating special purpose nanomaterials for viral therapy. The Company's novel nanoviricide® class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. The Company is developing drugs against a number of viral diseases including H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others.
.
.
.

http://www.fiercebiotech.com/press-releases/nanoviricides-retains-consulting-firm-expedite-first-flucide-human-trials-a

Any biotech do Phase 1, Phase 2, Phase 3 and possibly Phase 4 of human clinical trials but you are telling this forum that Preclinical/GLP cannot be divided into Phase 1, 2 and 3? Weak. Perhaps you may want to write Australian Biologics Pty, Ltd and then post here their reply/answer. Yes, you can!

Here is a company that did Preclinical studies in one fell swoop, as you claim!

NexBio...
-A small-biotech that is privately-held
-with Fludase a first-in-class Influenza drug
-government begins to grease skids for the small-biotech, Aug 8, 2005?
-a 50m contract with the NIH, fast-tracked

Why would a privately-held company, that seems to have everything going for them, would feel the urge to defraud the United States of America/taxpayers funded NIH? Cash-flow problems? with a 50m biologic-contract, how can that be?

Since its founding in 2003, NexBio has received at least $73 million in grants and contracts from the National Institutes of Health to develop and test Fludase, according to agency records and a 2009 report from the San Diego industry group Biocom.

After operating solely with government funding, the company in recent years tried to raise money from investors. It isn't clear whether those efforts were successful.

Company officials did not respond to several telephone and email messages.

source: http://www.sandiegouniontribune.com/news/2011/aug/04/feds-raid-san-diego-vaccine-developer/

==========================================

For a GLP inspector it should be possible to look at the documentation and to easily find out

who has done a study,
how the experiment was carried out,-
which procedures have been used, and
whether there has been any problem and if so
how it has been solved.

And this should not only be possible during and right after the study has been finished but also 5 to 10 or more years later.

Frequently the question comes: how much does this cost? It has been estimated that these additional organizational and documentation requirements increase operational costs of up to 30% compared to non-GLP operation.

The key requirements of a GLP type works are

-Responsibilities should be defined for the sponsor management, for study management and for the quality assurance unit.
-All routine work should follow written standard operating procedures.
-Facilities such as laboratories should be large enough and have the right construction to ensure the integrity of a study, for example, to avoid cross contamination.
-Test and control articles should have the right quality and instruments should be calibrated and well maintained
-People should be trained or otherwise qualified for the job
-Raw data and other data should be acquired, processed and archived to ensure integrity of data.
http://www.labcompliance.com/tutorial/glp/