Apr 7 2015
NanoViricides, Inc., a nanomedicine company developing anti-viral drugs, reports on the Company's progress in the recent quarter.
Ebola
Using NanoViricides's rapid design platform, it took only 4 months from design to synthesis of the multiple EbolaCide drug candidates needed for study. In late January, these novel anti-Ebola drug candidates were sent to our collaborating BSL-4 facility for initial testing. Our drug candidates were found to be broad-spectrum, in that they were equally effective against Ebola virus as well as Marburg viruses. This is unlike the antibody-based, siRNA-based and antisense-based anti-Ebola therapeutics currently being advanced, which only work against specific strains with a very narrow and selective spectrum of activity. Broad-spectrum activity of our drug candidates is a very important and valuable characteristic, as it indicates that mutations of the virus in the field are unlikely to cause escape of the virus from our final EbolaCide™ drug. We believe that with the new insight we have gained, and with our experience from earlier studies, we can continue to optimize our multiple drug candidates before another Ebola epidemic strikes. The recent outbreak in Africa, though now waning, has unequivocally demonstrated the need for an effective, broad-spectrum, anti-Ebola therapeutic in order to control any further outbreaks.
Herpes
The Company has also been working on its anti-herpes drug candidates. Our anti-HSV (herpes simplex virus) drug candidates have previously shown strong activity with >99.9% inhibition when tested against two significantly different strains of HSV-1 in cell culture studies. The anti-HSV drug candidates have since been further modified to improve effectiveness in dermal application in a small animal dermal HSV-1 infection model. The cell culture and animal studies have been completed as of today and we are now awaiting the reports. These studies were performed in Professor Ken Rosenthal's laboratory at the Northeast Ohio Medical University.
We anticipate that these broad-spectrum anti-HSV drug candidates would be effective against oral and skin lesions caused by HSV-1 strains, genital lesions caused by HSV-2 strains, herpes keratitis (a potentially blinding eye disease caused by HSV-1), and most probably against shingles as well. Shingles or zoster is a wide-spread skin disease that occurs from re-awakening of the chickenpox virus (namely, human herpesvirus-3 aka varicella zoster virus). VZV, like HSV-1 and HSV-2 is in the alpha-herpesvirus family. There are one million cases of shingles in the US yearly. There are approximately 25 million cases of genital herpes in the US on an annual basis.
Influenza
We are currently working to increase the production of FluCide™, our anti-influenza drug candidate. FluCide has been designed for use in hospitalized patients with complicated influenza. FluCide was found to be extremely safe in preliminary toxicology studies in mice and rats. As a result of the extreme safety finding, it was estimated that about 2.5kg of drug substance would be needed for the complete large animal toxicology studies. These studies are needed for filing an Investigational New Drug Application (IND). In mice, no adverse events were observed even at doses as high as 480 mg/kg/d repeated on five days (a total of 2,400 mg/kg), when given intraperitoneally. Similar strong safety was also observed in the initial part of the formal toxicology study in rats. In rats, no adverse events were observed with doses as high as 300mg/kg/d given by rapid intravenous infusion, and repeated for 14 days (a total of 4,200 mg/kg). We are in the process of producing a total of 2.5kg of FluCide for the final large animal toxicology studies. Our toxicology studies are being performed by BioAnalytical Systems, Inc. (BASI) of Indiana (NASDAQ: BASI).
We are now working to optimize all of the processes involved in the production of FluCide. Equipment needed for this task is being acquired, and is being installed by factory representatives as it arrives. Some items have lead times of 6 to 8 weeks for delivery. We are working as quickly as possible on setting up the production processes at our new state of the art c-GMP-capable manufacturing facility in Shelton, CT.
We are happy to announce that our Biological Characterization Group has now completely moved to our Shelton, CT campus. We are implementing a phased move to Shelton so that there is minimal impact on our continuing operations. We plan on continuing to use our West Haven facility to maximize R&D efforts on our large number of drug development programs.
Drug Pipeline
The Company has six commercially important drug development programs in its rich pipeline. These include (i) Injectable FluCide for hospitalized patients, (ii) Oral FluCide™ for out-patients with Influenza, (iii) broad spectrum HerpeCide™ for various forms of herpes virus infections that cause oral and genital herpes, herpes keratitis (eye disease), and possibly also chickenpox, and shingles, (iv) a broad-spectrum antiviral ophthalmic solution for viral diseases of the eye such as epidemic kerato-conjunctivitis (EKC, caused usually by adenoviruses), and herpes keratitis, (v) DengueCide™, a broad-spectrum drug against all four types of dengue viruses, and (vi) HIVCide™, a broad-spectrum anti-HIV drug candidate that may be a "functional cure" against HIV/AIDS. In addition, we are engaged in research programs for the development of broad-spectrum drug candidates against a number of other viruses. These include filoviruses such as Ebola and Marburg, Rabies, and many others. We continue to advance these programs as opportunities become available. In the past, we have been constrained by the limitation of our small laboratory R&D facility in West Haven, CT. We now have a 18,000 sq. ft. state of the art cGMP-capable manufacturing facility for clinical scale production of any of our nanomedicine dug candidates including injectables, located in Shelton, CT. We are now working to bring the facility into full-scale operation. We anticipate that this facility will dramatically expand our ability to move our drug candidates into a clinical stage pipeline.
The Company has previously announced that it had approximately $36.4 Million (M) of current assets plus restricted cash (cash, cash equivalents, collateral advance, prepaid expenses, and security deposits) as of December 31, 2014. The Company's operating expenditure is approximately $2M per quarter. We believe that we have sufficient funding available to perform initial human clinical studies on at least one of our drug candidates, and possibly to bring at least one other drug candidate into IND stage.