SHELTON, Conn., April 27, 2015 /PRNewswire/ -- NanoViricides, Inc., (NYSE MKT: NNVC) (the "Company"), a nanomedicine company developing anti-viral drugs, discusses the significance of the strong effectiveness demonstrated by its anti-viral drug candidates in a lethal animal model of dermal herpes infection.
NanoViricides, Inc. recently reported that its anti-Herpes drug candidates demonstrated substantially complete survival of mice that were lethally infected with the HSV-1 H129c strain. In contrast, acyclovir, the standard of care drug, resulted in only a limited survival (less than 58%), even though it was employed at twice the human drug concentration. Further, the survival improvement correlated with the reduction in clinical disease scores, demonstrating significant reduction in disease severity.
These results are very significant considering that topical acyclovir in the form of a cream as well as an ointment are approved for the treatment of cold sores.
Our strong anti-herpes nanoviricide® drug candidates are capable of reaching approval as drug for topical use against herpes cold sores, the Company believes, based on these datasets. Further drug development is necessary towards the goal of drug approval.
The Company intends to meet with its FDA advisory consulting group, namely, Biologics Consulting Group, Inc., to chart out the path towards approval. In addition, the Company intends to engage a Contract Research Organization (CRO) for further development of a topical anti-herpes drug into the regulatory approval pathway for US FDA as well as internationally.
"A rapid drug approval process is possible for our anti-herpes nanoviricide® topical skin treatment," said Eugene Seymour, MD, MPH, "We intend to investigate the regulatory pathway and intend to put our anti-herpes drug candidates into the approval process as soon as feasible."
"The pace of development of our broad drug pipeline is now accelerating due to the strong financing we have been able to raise concomitant with our up-listing to the NYSE-MKT exchange," said Anil R. Diwan, PhD, President.
In another news, the Company reports that the process of commissioning of its new facility in Shelton is on course. Our Bio-Analysis Group has already moved operations to the new facility. Large Scale Chemistry Group is completing the necessary modifications to the facility to enable large scale production processes. Various laboratory instruments are being installed by vendors under warranty programs for installation qualification and operational qualification.
In just four cycles of further improvements undertaken since 2010, the Company has now reached its goal of substantially complete survival in the highly lethal animal model of dermal herpesvirus infection (HSV-1 H129c strain), wherein no current drugs have shown substantial survival effect. Our anti-Herpes program began in 2009, and soon thereafter, the Company demonstrated strong anti-herpes efficacy in cell cultures against two different HSV-1 strains at two different sites. Since then the Company has been optimizing the drug candidates to achieve strong effectiveness in a highly lethal animal model. Due to resource constraints, the Company has been able to perform these studies only sporadically. Since up-listing in late 2013 and raising significant amounts of financing, the Company has been able to make strong further progress against Herpes that has resulted in the recent achievements.
The reported studies were performed in Professor Ken Rosenthal's laboratory at the NorthEast Ohio Medical University (NEOMED). Professor Rosenthal retired last year and continued as Professor Emeritus at NEOMED. Even after his retirement, he continued his research, and was personally involved in on-going studies of nanoviricides drug candidates in his laboratory. Professor Rosenthal has now joined Roseman University of Health Sciences, Las Vegas, Nevada, as a Professor of Biomedical Sciences. He will continue as a consultant to NanoViricides for our anti-herpes drug development program.
The nanoviricides® mechanism of action is believed to mimic a natural host cell receptor using which the virus binds and infects cells; binding of a nanoviricide nanomicelle to the virus is expected to render it non-infectious. A nanoviricide would thus stop the spread of the viral infection to new uninfected cells. This mechanism is different from that of currently available anti-Herpes drugs. The Company therefore believes that it is able to develop broad-spectrum anti-herpes nanoviricide drugs.
The market size for herpes simplex virus treatments is in excess of $2 billion annually. The Company estimates that an effective treatment could lead to a doubling in the market size.
NanoViricides, Inc. (www.nanoviricides.com) is a development stage company that is creating special purpose nanomaterials for antiviral 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.
This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in pre-clinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.
SOURCE NanoViricides, Inc.