From yesterday's 10K
During the financial year ending June 30, 2015, we have continued to make significant progress in advancing our drug pipeline, improving our resources, as well as improving our corporate governance and executive capabilities. Significantly, in December 2014, NanoViricides completed purchase of the modern c-GMP-capable production and R&D facilities at 1 Controls Drive, Shelton, CT, from Inno-Haven, LLC, at cost (for details, see below). NanoViricides as well as our affiliates have added significant strength in our staffing, with the R&D staff more than doubling to over 20 persons this year. Our new campus in Shelton has enabled this substantial expansion of our capabilities. This expansion is necessary to accomplish the substantial amount of scientific investigations, process engineering, quality engineering, large scale production and document preparation that goes towards filing investigational new drug applications (IND’s) to the US Food and Drug Administration (“FDA”), and equivalent applications to regulatory agencies across the globe. This expansion has also enabled us to strengthen our novel platform technologies, and engage into further novel, application-oriented R&D work directed to the goal of eradication of viral diseases.
In addition to our anti-influenza drug for hospitalized, severely ill patients in the FluCide™ program, our herpeCide™ program has now advanced into a late pre-clinical stage, wherein optimization for various disease indications related to different herpesvirus infections is now being undertaken, such as eye drops and gel formulations for ocular herpes keratitis, skin creams for oral herpes “cold sores”, for genital herpes lesions, and for shingles (which is caused by the herpesvirus called Varicella-Zoster virus that also causes chickenpox in children).
It is believed that the development of the topical anti-herpes drug candidates may be significantly faster and easier than the development of the injectable FluCide that we are currently working on. Therefore, we have planned on continuing the development of the HerpeCide drug candidates as well as the FluCide drug candidate towards clinical trials in parallel. With the expanded R&D labs, Analytical Labs, the new Bio labs, the new Process Scale-Up production facility, and the new cGMP-capable manufacturing facility established at our new Shelton campus, we are in a much stronger position than ever to move our drug development programs into the clinic rapidly.
We now have two advanced pre-clinical drug candidates, namely, our injectable FluCide for severely ill patients, and our HerpeCide skin treatment for oral herpes cold sores. In addition, our HerpeCide program is poised to produce additional advanced candidates against ocular herpes and shingles. Our animal efficacy studies are performed by third parties. We opt into drug developments against specific disease indications for which we have appropriate partners that can perform the necessary cell culture and animal efficacy studies.
NanoViricides technology is now maturing rapidly toward the clinic, with the new facility, expanded staff, and the financial strength that we have attained since uplisting to NYSE-MKT.
We focused our drug development work plans primarily on our lead Influenza drug candidate, and our anti-Herpes-virus programs during the reporting financial year.
As part of the advanced IND–enabling development of our Injectable FluCide™ drug candidate, we performed initial safety-toxicology screening of an optimized FluCide® drug candidate in a GLPlike toxicology study in rats. We reported that a good safety profile was observed for this drug candidate in rats, around the end of January 2015. These results are in agreement with the previously reported results of a non-GLP toxicology study in mice. The current study results also support the Company’s positive findings in animal models of infection with different influenza A virus strains in which no safety or toxicology concerns were observed. The Company has previously reported that many of its FluCide candidates demonstrated extremely high anti-influenza activity in those models.
These results are extremely important since they indicate that FluCide continuesto look very promising as one of the most advanced candidates in the Company’s drug development pipeline.
The next phase of the toxicology package studies for injectable FluCide will involve larger animals, and are estimated to require much larger quantities of the anti-influenza drug candidate. In order to accomplish this, we have continued to scale up our production processes for both the backbone polymer and the ligands at our new Shelton facility. We believe that we will be able to make as much as a few kilograms in a single batch in the new cGMP-capable facility. We have continued to work successfully towards large-scale production of this anti-Influenza drug candidate. The Scale-Up Laboratory in our new Shelton campus now has the necessary equipment for this scale up. During and after each step is completed at the large scale, we must maintain certain process controls, obtain relevant data, and thereafter characterize the resulting products by various methods. This is a tedious, laborious, and time-consuming process.
In addition, in August 2014, we restarted our anti-Ebola drug development program in response to the then raging Ebola epidemic in Africa. Our materials testing agreement with US Army Medical Research in Infectious Diseases (USAMRIID) unfortunately took substantial amount of time to restart. We executed a CRADA (Collaborative Research and Development Agreement for Material Transfer) with the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) at the end of October, 2014. We were able to send a first panel of novel agents to USAMRIID at the end of January, 2015. We received initial test results in early March, 2015. The nanoviricides approach was found to be very promising in these cell culture studies. We mutually decided with
USAMRIID scientists that we should perform another round of improvement of the drug candidates. However, around this time, in early April 2015, the epidemic had begun to be brought under control by the international public health agencies with heroic efforts - despite the lack of treatments or vaccines - and the urgency of our Ebola program, which we engaged into because of the potential global epidemic threat, was no longer apparent. In addition, several drug candidates by other companies had been fortuitously advanced into various modified protocols of clinical trials by that time. With these changes in the global Ebola scenario, NanoViricides determined around May 2015 that we should re-focus our efforts on our commercially important priorities.
(These paragraphs in my opinion say that neither Nanoviricides nor any other candidates worked for Ebola)
We restarted the Ebola program based on our evaluation and belief that an optimized nanoviricide anti-Ebola drug candidate would have been the only viable option, had the epidemic continued to evolve into a global threat. Our belief is now supported by evidence. All of the anti-Ebola drug candidates that were advanced into clinical trials during the epidemic have been either rescinded by the sponsors or have not met statistically significant effectiveness end-points. These candidates include the siRNA therapeutics by Tekmira, antibody cocktail therapeutics by zMAPP, brincidofovir by Chimerix, and favipravir (T-705) by Takeda. In addition, Sarepta and BioCryst did not advance their anti-Ebola drug candidates into efficacy clinical trials.
This year, we also continued our work in our HerpeCide program, encouraged by results in animal studies. We are happy to report that our HerpeCide™ program is now maturing towards selection of final development candidates against several different indications.
In April 2015, we reported dramatic improvement in clinical symptoms associated with a herpes simplex virus dermal infection in recently completed studies in mice. The topical nanoviricide treatment significantly reduced the clinical disease, and led to >85% survival of the mice dermally infected with a highly aggressive, neurotropic, HSV-1 H129c strain, wherein all of the untreated mice had severe clinical morbidity and none of the untreated mice survived. Recently in August, we reported that these results were reproduced at a different laboratory, with 100% survival being observed.
The potential broad-spectrum nature of our anti-HSV drug candidates is expected to enable several antiviral indications. Thus, HSV-1 primarily affects skin and mucous membranes causing “cold sores”. HSV-2 primarily affects skin and mucous membranes leading to genital herpes. HSV-1 infection of the eye causes herpes keratitis that can lead to blindness in some cases. In addition, human herpesvirus-3 (HHV-3) aka varicella-zoster virus (VZV) causes chickenpox in children and when reactivated in adults, causes shingles. Shingles breakouts are amenable to topical treatment, as are the HSV cold sores, genital lesions, and herpes keratitis of the eye. Most of these indications do not have satisfactory treatments at present, if any. Further, the treatment of herpesvirus infections caused by acyclovir- and famciclovir- resistant mutants is currently an unmet medical need.
Topical treatment of herpesvirus infection is important because herpesviruses become latent in neuronal cells or in ganglia, and cause periodic localized breakouts that appear as skin rashes and lesions. Systemic drug treatment results in side effects because of the high systemic drug concentrations that need to be achieved and the large drug quantities that must be administered. Since the virus remains mostly localized in the area of the rash and connected nerve apparatus, using high concentrations of drugs delivered in small quantities topically would allow maximizing the effectiveness while minimizing the side effects.
The current market size for drugs for the treatment of herpes infections is about $2~4B. We believe that when an effective topical treatment is introduced, the market size is likely to expand substantially.
The Nanoviricides® technology continues to receive substantial attention and recognition in the scientific world. The NanoViricides Executive Team is also receiving recognition for the Company’s achievements.
Our “Injectable FluCide™” drug candidate for severe influenza was chosen as one of the “Top Ten Infectious Diseases Projects to Watch” by a panel of industry experts assembled by Informa and the publishers of In Vivo, Startup and The Pink Sheet. As a result of this selection, Anil R. Diwan, PhD, President and Chairman of the Company, gave a company presentation at the Therapeutic Area Partnerships Meeting on November 20, 2014.
In addition, NanoViricides was selected as one of the top 20 finalists in the “technologies of Tomorrow” segment of the “Buzz of BIO” spot for the BIO2015 conference in Philadelphia, PA. While NanoViricides did not win the top spot in the final voting, the selection itself speaks to recognition of the Company in the prestigious pharmaceutical industry community.
NanoViricides continues to make strides in improving our corporate governance. To this end, we have engaged EisnerAmper LLP as our new public auditors, switching from the smaller firm of Li & Company. EisnerAmper LLP found that in the previous year, we had not accounted for the derivative effect of certain warrants and debentures issued last year according to the required rules. While this does not affect our core financial position, we have corrected this defect and this has resulted in amended and restated filings of previous annual report and two quarterly reports. In addition, we have recently added a new Accounting Manager to our finance department to strengthen the processes and to provide additional oversight.
