World Health Organization Accelerating Diagnostics, Vaccines, Therapeutics For Novel Coronavirus

PALM BEACH, FLORIDA, Jan. 23, 2020 /PRNewswire/ -- Since The Chinese authorities identified a new type of coronavirus, (novel coronavirus 2019-nCoV) from Wuhan, Hubei Province, China, which was isolated on 7 January 2020, the World Health Organization (WHO), governments and laboratories around the world have been coordinating the search to contain and diagnose and treat this new worldwide threat. This week experts at the World Health Organization will meet to decide whether to declare the outbreak a "public health emergency of international concern," a label given to "serious public health events that endanger international public health" and "potentially require a coordinated international response." WHO is working with their networks of researchers and other experts to coordinate global work on surveillance, epidemiology, modelling, diagnostics, clinical care and treatment, and other ways to identify, manage the disease and limit onward transmission. WHO has issued interim guidance for countries, updated to take into account the current situation.   Mentioned in today's commentary include:  NanoViricides, Inc. (NYSE: NNVC), Novavax, Inc. (NASDAQ: NVAX), BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX), Aethlon Medical, Inc. (NASDAQ: AEMD), Neurotrope, Inc. (NASDAQ: NTRP)

The New York Times reported that: "Public health officials around the world are on alert because the new infection is caused by a coronavirus, from the same family that caused outbreaks of SARS and MERS, killing hundreds of people in dozens of countries.  The W.H.O. has already advised governments to be prepared for the disease, to be vigilant and ready to test anyone with symptoms like cough and fever who has traveled to affected regions. Air travel is expected to surge as the Lunar New Year approaches this weekend."

But important questions about the outbreak are still unanswered, and W.H.O.'s expert committee now must grapple with significant unknowns.  "We don't know how many people are infected," said Tarik Jasarevic, a spokesman for the W.H.O. "The more you test, the more you will find people who are infected. We don't know if there are asymptomatic cases. If they are asymptomatic, are they contagious?"  Broad studies to test for evidence of infection, past and present, would give a true picture of how many people have been exposed to the virus.

One company to keep a close eye on, in the emerging sector, is NanoViricides, Inc. (NYSE American: NNVC).    Nanoviricides' platform technology enables the development of a drug against a new virus rather quickly. Previously, during MERS outbreak (which is a coronavirus, albeit not the same as Wuhan), and also in the 2014-2015 Ebola outbreak, they had worked on developing drugs against those viruses. NanoViricides has two drug candidates with potentially multi-billion indications in the pipeline focused on Shingles and Herpes. The company recently announced positive results - Adding Coronavirus would potentially give the industry three (3) shots on goal. 

Dr. Anil Diwan, PhD. of NanoViricides, Inc recently stated, "NanoViricides develops drugs (therapeutics) to treat the virus or viral disease. We do not develop vaccines. In sporadic outbreaks, vaccines are not useful for many reasons, including the fact that they cannot be developed sufficiently rapidly in the quantities needed to treat large numbers of people, and associated logistics.

Our technology enables the development of a drug against a new virus rather quickly. Previously, during MERS outbreak (which is a coronavirus, albeit not the same as Wuhan), and also in the 2014-2015 Ebola outbreak, we had worked on developing drugs against those viruses.

We believe that some of the broad-spectrum agents we had previously developed are worth testing against the Wuhan virus, and are likely to work against it. We would very much like to invite CDC and NIH to help us with the animal testing of our candidates.

Our first drug candidate against shingles, namely NV-HHV-101, has gone through all required safety/toxicology animal testing successfully. Therefore, if there is a perceived crisis of a magnitude where we can access help from government labs, we would be able to perform screening and hopefully develop a drug candidate that can help. There are several regulations for human use of experimental, novel drugs. We will need to work with that framework."

NanoViricides, Inc. also this week announced the pricing of an underwritten public offering with gross proceeds to the Company of $7.5 million before deducting underwriting and other estimated offering expenses. The offering is 2.5 million shares of the Company's common stock at a price of $3.00 per share. The Company intends to use the net proceeds from this offering to fund general corporate purposes and to fund ongoing operations and to repay certain accounts payable to related parties.

The Company has also granted the underwriters a 45-day option to purchase up to 375,000 additional shares of common stock to cover over-allotments at the public offering price, which would result in an additional $1.125 million in gross proceeds, for a total of $8.6 million.

In other biotech news in the markets this week: 

Novavax, Inc. (NASDAQ: NVAX) recently announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for NanoFlu™, its recombinant quadrivalent seasonal influenza vaccine candidate, adjuvanted with Matrix-M™, in adults 65 years of age and older.

"The FDA's decision to grant Fast Track Designation for NanoFlu reflects the urgent unmet medical need for a more effective vaccine against influenza, particularly in the older adult population which often experiences serious and sometimes life-threatening complications, of the disease" said Stanley C. Erck, President and Chief Executive Officer of Novavax. "We believe that NanoFlu will offer an innovative improvement compared to traditional egg-based vaccines, which frequently result in mismatch and poor effectiveness. We look forward to working closely with the FDA through the expedited review process, accelerating the access to this vaccine for the most vulnerable populations."

BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX) recently announced the appointments of Charles Gayer as chief commercial officer and Allen Hodge as vice president and general manager for the United States.

Mr. Gayer joined BioCryst in 2015 as vice president of global strategic marketing. Since July 2019 he has served as interim chief commercial officer, playing a key role in defining the strategy, and building the commercial operations, to support the launch of berotralstat, BioCryst's oral kallikrein inhibitor for hereditary angioedema (HAE).

Aethlon Medical, Inc. (NASDAQ: AEMD) makes a medical device called the Hemopurifier, which is designed to quickly eliminate viral pathogens from the circulatory system. The company said in 2016 that among the pathogens it could remove from the bloodstream were those known as Middle East Respiratory Syndrome Coronavirus (MERS-CoV). 

Beyond human treatment experiences, pre-clinical Hemopurifier studies have validated the broad-spectrum capture of numerous viral threats. These include: Chikungunya, Dengue and West Nile virus, as well as Vaccinia and Monkey pox, which serve as models for human Smallpox infection. Specific to pandemic influenza threats, Aethlon has validated the capture of H5N1 avian flu, H1N1 swine flu, and the reconstructed 1918 influenza virus, which represents a model for the strain of influenza that killed an estimated 50 million victims in 1918 and 1919. In vitro studies of other viral threats are ongoing.

Neurotrope, Inc. (NASDAQ: NTRP) recently announced its corporate update.  The Company has completed analysis of the data (Clinical Study Report) from its recently reported Phase 2 confirmatory clinical trial (the "203 study"), examining moderately severe to severe Alzheimer's disease patients treated with Byrostatin-1 in the absence of memantine / Namenda.

"A significant imbalance (4.8 points) in the baseline Severe Impairment Battery ("SIB") scores occurred, by chance, between the Bryostatin-1 treatment group and placebo group," stated Dr. Daniel Alkon, Neurotrope's President and Chief Scientific Officer.  "After consulting with our Scientific Advisory Board and statistical experts, we were advised that, in a small study such as this, a baseline imbalance could prevent a definitive analysis of Bryostatin-1 treatment versus placebo in SIB scores at the primary (Week #13) and secondary endpoints as provided in the original Statistical Analysis Plan ("SAP")," stated Dr. Alkon.

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