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.
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